Major Depressive DisorderNCT05775809
Prospective Clinical Cohort Study of Depression
An observational study of Major Depressive Disorder, run by Sir Run Run Shaw Hospital at 1 site in China.
Trial summary
This is a prospective clinical cohort study of depression. The study was intended to include 300 patients with depression and 100 healthy controls. The study consisted of two phases: the baseline period and the follow-up period, in which all subjects were comprehensively collected, and the follow-up period in which… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- selective serotonin reuptake inhibitors and TMS
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2023to 20 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Depression is a mental state characterized by persistent low mood, loss of interest and pleasure in daily activities, autonomic disorders and decreased energy, resulting in varying degrees of impairment of social and occupational functioning.
Who may be able to join
- Out-patient or in-patient aged 18-65 years (including 18 and 65 years), regardless of gender;
- The Chinese version of the Concise International Neuropsychiatric Interview (M.I.N.I.) 7.0.2 type interview, in line with the DSM-5 Diagnostic criteria for major depressive disorder, either first or recurrent;
- Screening and baseline Hamilton Depression Scale (HAMD-17) Score ≥14;
- No antidepressants were taken for at least 14 days prior to enrollment (patients treated with fluoxetine prior to enrollment should Stop for at least 28 days);
- A single class of antidepressant medication is planned;
- Primary school education or above, able to understand the research content;
- Understand and voluntarily participate in this study, and I sign the informed consent.
Who cannot join
- A current or previous DSM-5 diagnosis of a major mental disorder other than major depressive disorder, Such as neurodevelopmental disorders, neurocognitive disorders, schizophrenia and other psychotic disorders, bipolar disorder Sensory disorder, obsessive disorder, panic disorder, post-traumatic stress disorder, alcohol (or drug) dependence or abuse User and personality disorder;
- depression secondary to an organic mental disorder caused by a systemic disease or a neurological disease Seizures, such as depression caused by hypothyroidism;
- Severe or unstable cardiovascular, respiratory, liver, kidney, endocrine, hematological or other conditions Other systemic diseases were not considered suitable for inclusion in this study.
- During the screening period or baseline period, the investigators considered that the physical examination and laboratory examination of the patients were abnormal and judged to have significant clinical significance Bedsense;
- had received systemic Modified Electric therapy (Modified Electric) 3 months before screening Convulsive Therapy, MECT) or Transcranial Magnetic stimulation (Transcranial Magnetic Stimulation (TMS), Deep Brain Stimulation (DBS), Vagus Nerve Stimulation (VNS);
- The withdrawal of psychotropic drugs did not reach 7 half-lives before screening.
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective clinical cohort study of depression. The study was intended to include 300 patients with depression and 100 healthy controls. The study consisted of two phases: the baseline period and the follow-up period, in which all subjects were comprehensively collected, and the follow-up period in which all subjects were followed up at least once a year and data were collected. For patients with major depressive disorder, the follow-up methods included fixed visit and planned visit, and the follow-up time point covered the whole course of depressive disease(baseline, 2nd weekend±7days, 6th weekend±14days, 8th weekend±14days, 12th weekend±14days, Week 14-104 Every 4 weekends ± 14 days). Based on standardized, multi-strategy follow-up system and mobile health technology, long-term follow-up of patients with major depressive disorder was realized, and key nodes of patients' disease fluctuations were captured in time. High quality multidimensional data were collected, including demographic, clinical, EEG and eye movement data. Finally, the objective index system of depression was constructed, and the diagnosis, efficacy/recurrence prediction and suicide warning models of depression were established.
Read the detailed description
- Research Treatment 1.1 Drug treatment The patient did not take antidepressant treatment at least 14 days before enrollment (the patients treated with fluoxetine before enrollment should stop using it for at least 28 days). During 8 weeks, all subjects with major depressive disorder received effective dosages of selective serotonin reuptake inhibitors, and all subjects with major depressive disorder were limited to a single class of antidepressants. If the antidepressant treatment plan needed to be adjusted, one antidepressant should be selected as far as possible, and combined treatment with two or more antidepressants should not be allowed. Antipsychotics and mood stabilizers are not permitted. If the treatment of selective serotonin reuptake inhibitors is not effective after eight weeks, the drugs can be considered for replacement. The drugs for replacement include but are not limited to selective serotonin reuptake inhibitors. 1.2 Other treatment Settings Psychotherapy and TMS are allowed. The method, frequency, and duration of therapy should be recorded. 1.3 Treatment compliance Participants were reminded to follow the medication regimen and their medication use was recorded at each visit. Non-use of prescription drugs for ≥70% of the time is considered noncompliance, and the reason for noncompliance should be checked. If there was a protocol violation, the protocol violation was recorded and the follow-up was continued as scheduled.
- Observation index
Main observation indicators:
Clinical effect: Changes of clinical symptoms in acute phase, maintenance phase and long-term follow-up period. Changes in HAMD-17 scores at different follow-up points compared with baseline were used as the main efficacy evaluation index in this study. The evaluation criteria of clinical efficacy and significant endpoints at different stages are as follows:
① Early onset: The total score of HAMD-17 decreased by more than 20% from baseline after 2 weeks of treatment;
② Effective: The total score of HAMD-17 was reduced by more than 50% compared with baseline; Stable and effective was defined as two consecutive HAMD-17 scores decreased by more than 50% from baseline at the 8th weekend of the acute phase.
2.1 A method of measuring or evaluating observational indicators
- General demographic data survey The patient's date of birth, gender, height, weight, nationality, marital status, occupation type and years of education were investigated.
Clinical information collection
2）Medical history information:
- Time of first onset of major depressive disorder/bipolar disorder
- The onset of the current depressive episode
- Total episodes (including this one) : depressive episodes
2.2 Scale evaluation(baseline, 2nd weekend±7days, 6th weekend±14days, 8th weekend±14days, 12th weekend±14days, Week 14-104 Every 4 weekends ± 14 days)：
We collect scale data of patients with major depressive disorder at different point (baseline, 2nd weekend±7days, 6th weekend±14days, 8th weekend±14days, 12th weekend±14days, Week 14-104 Every 4 weekends ± 14 days), and collect scale data of healthy controls during the baseline period.
self-rating scale： Snaith-Hamilton Pleasure Scale, SHAPS Generalized Anxiety Disorder,GAD-7 Patient Health Questionnare, PHQ-9 Hypomania Check List,HCL-33 Sheehan Disability Scale，SDS Childhood Trauma Questionnaire，CTQ Big 5 Personality Questionnaire， B5PQ Dysfunctional Attitude Scale，DAS Interpersonal Reactivity Index-C Scale for Suicide Ideation，SSI
Other rating scale Hamilton Depression Rating Scale for Depression - 17-item，HAMD-17 Hamilton Anxiety Scale，HAMA Brief Psychiatric Rating Scale, BPRS 4 items
2.3 EEG and eye movement data collection (baseline, 2nd weekend±7days, 6th weekend±14days, 8th weekend±14days, 12th weekend±14days, Week 14-104 Every 4 weekends ± 14 days)
We collect EEG and eye movement data of patients with major depressive disorder at different point(baseline, 2nd weekend±7days, 6th weekend±14days, 8th weekend±14days, 12th weekend±14days, Week 14-104 Every 4 weekends ± 14 days), and collect EEG and eye movement data of healthy controls during the baseline period.
- Conditions
- Major Depressive Disorder
- Being tested
- selective serotonin reuptake inhibitors, TMS
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
selective serotonin reuptake inhibitorsDrug
Also called Psychotherapy and TMS
Research Treatment Drug treatment The patient did not take antidepressant treatment at least 14 days before enrollment (the patients treated with fluoxetine before enrollment should stop using it for at least 28 days). During 8 weeks, all subjects with major depressive disorder received effective dosages of selective serotonin reuptake inhibitors, and all subjects with major depressive disorder were limited to a single class of antidepressants. If the treatment of selective serotonin reuptake inhibitors is not effective after eight weeks, the drugs can be considered for replacement. The drugs for replacement include but are not limited to selective serotonin reuptake inhibitors.
Other treatment Settings Psychotherapy and TMS are allowed. The method, frequency, and duration of therapy should be recorded.
TMSDevice
TMS are allowed. The method, frequency, and duration of therapy should be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Patients with major depressive disorder | We collect data of patients with major depressive disorder at different point (baseline, 2nd weekend±7days, 6th weekend±14days, 8th weekend±14days, 12th weekend±14days, Week 14-104 Every 4 weekends ± 14 days). Receives: Drug: selective serotonin reuptake inhibitors; Device: TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
score of Snaith-Hamilton Pleasure Scale, SHAPS
rating scale
Measured: baseline
Generalized Anxiety Disorder,GAD-7
rating scale
Measured: baseline
Patient Health Questionnare, PHQ-9
rating scale
Measured: baseline
Hypomania Check List,HCL-33
rating scale
Measured: baseline
Sheehan Disability Scale，SDS
rating scale
Measured: baseline
Childhood Trauma Questionnaire，CTQ
rating scale
Measured: baseline
Big 5 Personality Questionnaire， B5PQ
rating scale
Measured: baseline
Dysfunctional Attitude Scale，DAS
rating scale
Measured: baseline
Interpersonal Reactivity Index-C
rating scale
Measured: baseline
Scale for Suicide Ideation，SSI
rating scale
Measured: baseline
Hamilton Depression Rating Scale for Depression - 17-item，HAMD-17
rating scale
Measured: baseline
Hamilton Anxiety Scale，HAMA
rating scale
Measured: baseline
Brief Psychiatric Rating Scale, BPRS 4 items
rating scale
Measured: baseline
score of Snaith-Hamilton Pleasure Scale, SHAPS
rating scale
Measured: 2nd weekend±7days,
score of Generalized Anxiety Disorder,GAD-7
rating scale
Measured: 2nd weekend±7days,
score of Patient Health Questionnare, PHQ-9
rating scale
Measured: 2nd weekend±7days,
score of Hypomania Check List,HCL-33
rating scale
Measured: 2nd weekend±7days,
score of Sheehan Disability Scale，SDS
rating scale
Measured: 2nd weekend±7days,
score of Interpersonal Reactivity Index-C
rating scale
Measured: 2nd weekend±7days,
score of Scale for Suicide Ideation，SSI
rating scale
Measured: 2nd weekend±7days,
Hamilton Depression Rating Scale for Depression - 17-item，HAMD-17
rating scale
Measured: 2nd weekend±7days,
Hamilton Anxiety Scale，HAMA
rating scale
Measured: 2nd weekend±7days,
score of Snaith-Hamilton Pleasure Scale, SHAPS
rating scale
Measured: 6th weekend±14days,
Generalized Anxiety Disorder,GAD-7
rating scale
Measured: 6th weekend±14days,
Patient Health Questionnare, PHQ-9
rating scale
Measured: 6th weekend±14days,
Hypomania Check List,HCL-33
rating scale
Measured: 6th weekend±14days,
Sheehan Disability Scale，SDS
rating scale
Measured: 6th weekend±14days,
Interpersonal Reactivity Index-C
rating scale
Measured: 6th weekend±14days,
Scale for Suicide Ideation，SSI
rating scale
Measured: 6th weekend±14days,
Hamilton Depression Rating Scale for Depression - 17-item，HAMD-17
rating scale
Measured: 6th weekend±14days,
Hamilton Anxiety Scale，HAMA
rating scale
Measured: 6th weekend±14days,
score of Snaith-Hamilton Pleasure Scale, SHAPS
rating scale
Measured: 8th weekend±14days,
score of Generalized Anxiety Disorder,GAD-7
rating scale
Measured: 8th weekend±14days,
score of Patient Health Questionnare, PHQ-9
rating scale
Measured: 8th weekend±14days,
score of Hypomania Check List,HCL-33
rating scale
Measured: 8th weekend±14days,
score of Sheehan Disability Scale，SDS
rating scale
Measured: 8th weekend±14days,
score of Interpersonal Reactivity Index-C
rating scale
Measured: 8th weekend±14days,
score of Scale for Suicide Ideation，SSI
rating scale
Measured: 8th weekend±14days,
score of Hamilton Depression Rating Scale for Depression - 17-item，HAMD-17
rating scale
Measured: 8th weekend±14days,
score of Hamilton Anxiety Scale，HAMA
rating scale
Measured: 8th weekend±14days,
score of Snaith-Hamilton Pleasure Scale, SHAPS
rating scale
Measured: 12th weekend±14days,
score of Generalized Anxiety Disorder,GAD-7
rating scale
Measured: 12th weekend±14days,
score of Patient Health Questionnare, PHQ-9
rating scale
Measured: 12th weekend±14days,
score of Hypomania Check List,HCL-33
rating scale
Measured: 12th weekend±14days,
score of Sheehan Disability Scale，SDS
rating scale
Measured: 12th weekend±14days,
score of Interpersonal Reactivity Index-C
rating scale
Measured: 12th weekend±14days,
score of Scale for Suicide Ideation，SSI
rating scale
Measured: 12th weekend±14days,
score of Hamilton Depression Rating Scale for Depression - 17-item，HAMD-17
rating scale
Measured: 12th weekend±14days,
score of Hamilton Anxiety Scale，HAMA
rating scale
Measured: 12th weekend±14days,
score of Snaith-Hamilton Pleasure Scale, SHAPS
rating scale
Measured: Week 14-104 Every 4 weekends ± 14 days
Generalized Anxiety Disorder,GAD-7
rating scale
Measured: Week 14-104 Every 4 weekends ± 14 days
score of Patient Health Questionnare, PHQ-9
rating scale
Measured: Week 14-104 Every 4 weekends ± 14 days
score of Hypomania Check List,HCL-33
rating scale
Measured: Week 14-104 Every 4 weekends ± 14 days
score of Sheehan Disability Scale，SDS
rating scale
Measured: Week 14-104 Every 4 weekends ± 14 days
score of Interpersonal Reactivity Index-C
rating scale
Measured: Week 14-104 Every 4 weekends ± 14 days
score of Scale for Suicide Ideation，SSI
rating scale
Measured: Week 14-104 Every 4 weekends ± 14 days
score of Hamilton Depression Rating Scale for Depression - 17-item，HAMD-17
rating scale
Measured: Week 14-104 Every 4 weekends ± 14 days
score of Hamilton Anxiety Scale，HAMA
rating scale
Measured: Week 14-104 Every 4 weekends ± 14 days
average power of 4 bands: δ (1-4 Hz)、 θ (4-8 Hz)、 α (8-13 Hz)、 β (13-30 Hz)
EEG features
Measured: baseline
1.Average duration of EEG microstates 2. The average number of occurrences of EEG microstates per second 3. Average percentage of time covered by EEG microstates 4.the calculation of microstate transition.
EEG features
Measured: baseline
Connectivity index of full-band brain function network, and connectivity index of each band brain function network
EEG features
Measured: baseline
EEG features extracted by machine learning
EEG features
Measured: baseline
average power of 4 bands: δ (1-4 Hz)、 θ (4-8 Hz)、 α (8-13 Hz)、 β (13-30 Hz)
EEG features
Measured: 2nd weekend±7days
Average duration of EEG microstates 2. The average number of occurrences of EEG microstates per second 3. Average percentage of time covered by EEG microstates 4.the calculation of microstate transition.
EEG features
Measured: 2nd weekend±7days
Connectivity index of full-band brain function network, and connectivity index of each band brain function network
EEG features
Measured: 2nd weekend±7days
EEG features extracted by machine learning
EEG features
Measured: 2nd weekend±7days
average power of 4 bands: δ (1-4 Hz)、 θ (4-8 Hz)、 α (8-13 Hz)、 β (13-30 Hz)
EEG features
Measured: 6th weekend±14days
1.Average duration of EEG microstates 2. The average number of occurrences of EEG microstates per second 3. Average percentage of time covered by EEG microstates 4.the calculation of microstate transition.
EEG features
Measured: 6th weekend±14days
Connectivity index of full-band brain function network, and connectivity index of each band brain function network
EEG features
Measured: 6th weekend±14days
EEG features extracted by machine learning
EEG features
Measured: 6th weekend±14days
average power of 4 bands: δ (1-4 Hz)、 θ (4-8 Hz)、 α (8-13 Hz)、 β (13-30 Hz)
EEG features
Measured: 8th weekend±14days
1.Average duration of EEG microstates 2. The average number of occurrences of EEG microstates per second 3. Average percentage of time covered by EEG microstates 4.the calculation of microstate transition.
EEG features
Measured: 8th weekend±14days
Connectivity index of full-band brain function network, and connectivity index of each band brain function network
EEG features
Measured: 8th weekend±14days
EEG features extracted by machine learning
EEG features
Measured: 8th weekend±14days
average power of 4 bands: δ (1-4 Hz)、 θ (4-8 Hz)、 α (8-13 Hz)、 β (13-30 Hz)
EEG features
Measured: 12th weekend±14days
1.Average duration of EEG microstates 2. The average number of occurrences of EEG microstates per second 3. Average percentage of time covered by EEG microstates 4.the calculation of microstate transition.
EEG features
Measured: 12th weekend±14days
Connectivity index of full-band brain function network, and connectivity index of each band brain function network
EEG features
Measured: 12th weekend±14days
EEG features extracted by machine learning
EEG features
Measured: 12th weekend±14days
average power of 4 bands: δ (1-4 Hz)、 θ (4-8 Hz)、 α (8-13 Hz)、 β (13-30 Hz)
EEG features
Measured: Week 14-104 Every 4 weekends ± 14 days
1.Average duration of EEG microstates 2. The average number of occurrences of EEG microstates per second 3. Average percentage of time covered by EEG microstates 4.the calculation of microstate transition.
EEG features
Measured: Week 14-104 Every 4 weekends ± 14 days
Connectivity index of full-band brain function network, and connectivity index of each band brain function network
EEG features
Measured: Week 14-104 Every 4 weekends ± 14 days
EEG features extracted by machine learning
EEG features
Measured: Week 14-104 Every 4 weekends ± 14 days
Eye movement index
Collect resting eye movement data and task eye movement data. For eye movement data, features are extracted from blinking, scanning, staring, pupil diameter, initial fixation latency, initial fixation duration, total fixation duration and area of interest and so on.
Measured: baseline
Eye movement index
Collect resting eye movement data and task eye movement data. For eye movement data, features are extracted from blinking, scanning, staring, pupil diameter, initial fixation latency, initial fixation duration, total fixation duration and area of interest and so on.
Measured: 2nd weekend±7days
Eye movement index
Collect resting eye movement data and task eye movement data. For eye movement data, features are extracted from blinking, scanning, staring, pupil diameter, initial fixation latency, initial fixation duration, total fixation duration and area of interest and so on.
Measured: 6th weekend±14days
Eye movement index
Collect resting eye movement data and task eye movement data. For eye movement data, features are extracted from blinking, scanning, staring, pupil diameter, initial fixation latency, initial fixation duration, total fixation duration and area of interest and so on.
Measured: 8th weekend±14days
Eye movement index
Collect resting eye movement data and task eye movement data. For eye movement data, features are extracted from blinking, scanning, staring, pupil diameter, initial fixation latency, initial fixation duration, total fixation duration and area of interest and so on.
Measured: 12th weekend±14days
Eye movement index
Collect resting eye movement data and task eye movement data. For eye movement data, features are extracted from blinking, scanning, staring, pupil diameter, initial fixation latency, initial fixation duration, total fixation duration and area of interest and so on.
Measured: Week 14-104 Every 4 weekends ± 14 days
Eye movement features extracted by machine learning
Eye movement features extracted by machine learning
Measured: baseline
Eye movement features extracted by machine learning
Eye movement features extracted by machine learning
Measured: 2nd weekend±7days
Eye movement features extracted by machine learning
Eye movement features extracted by machine learning
Measured: 6th weekend±14days
Eye movement features extracted by machine learning
Eye movement features extracted by machine learning
Measured: 8th weekend±14days
Eye movement features extracted by machine learning
Eye movement features extracted by machine learning
Measured: 12th weekend±14days
Eye movement features extracted by machine learning
Eye movement features extracted by machine learning
Measured: Week 14-104 Every 4 weekends ± 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start15 Jun 2023
- Primary completion1 Dec 2023 (estimated)
- Study completion20 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Sir Run Run Shaw HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanhui Liao, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05775809
- Sponsor's protocol ID
- 2022-0334
- Status last verified
- Oct 2023
- First submitted
- 10 Feb 2023
- Last updated
- 27 Oct 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Cohort Study of Depression
- ClinicalTrials.gov ID
- NCT05775809
- Acronym / sponsor ID
- 2022-0334
- Conditions
- Major Depressive Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 20 May 2024 (estimated)
- First posted
- 20 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective clinical cohort study of depression. The study was intended to include 300 patients with depression and 100 healthy controls. The study consisted of two phases: the baseline period and the follow-up period, in which all subjects were comprehensively collected, and the follow-up period in which all subjects were followed up at least once a year and data were collected. For patients with major depressive disorder, the follow-up methods included fixed visit and planned visit, and the follow-up time point covered the whole course of depressive disease(baseline, 2nd weekend±7days, 6th weekend±14days, 8th weekend±14days, 12th weekend±14days, Week 14-104 Every 4 weekends ± 14 days). Based on standardized, multi-strategy follow-up system and mobile health technology, long-term follow-up of patients with major depressive disorder was realized, and key nodes of patients' disease fluctuations were captured in time. High quality multidimensional data were collected, including demographic, clinical, EEG and eye movement data. Finally, the objective index system of depression was constructed, and the diagnosis, efficacy/recurrence prediction and suicide warning models of depression were established.
Detailed description
- Research Treatment 1.1 Drug treatment The patient did not take antidepressant treatment at least 14 days before enrollment (the patients treated with fluoxetine before enrollment should stop using it for at least 28 days). During 8 weeks, all subjects with major depressive disorder received effective dosages of selective serotonin reuptake inhibitors, and all subjects with major depressive disorder were limited to a single class of antidepressants. If the antidepressant treatment plan needed to be adjusted, one antidepressant should be selected as far as possible, and combined treatment with two or more antidepressants should not be allowed. Antipsychotics and mood stabilizers are not permitted. If the treatment of selective serotonin reuptake inhibitors is not effective after eight weeks, the drugs can be considered for replacement. The drugs for replacement include but are not limited to selective serotonin reuptake inhibitors. 1.2 Other treatment Settings Psychotherapy and TMS are allowed. The method, frequency, and duration of therapy should be recorded. 1.3 Treatment compliance Participants were reminded to follow the medication regimen and their medication use was recorded at each visit. Non-use of prescription drugs for ≥70% of the time is considered noncompliance, and the reason for noncompliance should be checked. If there was a protocol violation, the protocol violation was recorded and the follow-up was continued as scheduled.
- Observation index
Main observation indicators:
Clinical effect: Changes of clinical symptoms in acute phase, maintenance phase and long-term follow-up period. Changes in HAMD-17 scores at different follow-up points compared with baseline were used as the main efficacy evaluation index in this study. The evaluation criteria of clinical efficacy and significant endpoints at different stages are as follows:
① Early onset: The total score of HAMD-17 decreased by more than 20% from baseline after 2 weeks of treatment;
② Effective: The total score of HAMD-17 was reduced by more than 50% compared with baseline; Stable and effective was defined as two consecutive HAMD-17 scores decreased by more than 50% from baseline at the 8th weekend of the acute phase.
2.1 A method of measuring or evaluating observational indicators
- General demographic data survey The patient's date of birth, gender, height, weight, nationality, marital status, occupation type and years of education were investigated.
Clinical information collection
2）Medical history information:
- Time of first onset of major depressive disorder/bipolar disorder
- The onset of the current depressive episode
- Total episodes (including this one) : depressive episodes
2.2 Scale evaluation(baseline, 2nd weekend±7days, 6th weekend±14days, 8th weekend±14days, 12th weekend±14days, Week 14-104 Every 4 weekends ± 14 days)：
We collect scale data of patients with major depressive disorder at different point (baseline, 2nd weekend±7days, 6th weekend±14days, 8th weekend±14days, 12th weekend±14days, Week 14-104 Every 4 weekends ± 14 days), and collect scale data of healthy controls during the baseline period.
self-rating scale： Snaith-Hamilton Pleasure Scale, SHAPS Generalized Anxiety Disorder,GAD-7 Patient Health Questionnare, PHQ-9 Hypomania Check List,HCL-33 Sheehan Disability Scale，SDS Childhood Trauma Questionnaire，CTQ Big 5 Personality Questionnaire， B5PQ Dysfunctional Attitude Scale，DAS Interpersonal Reactivity Index-C Scale for Suicide Ideation，SSI
Other rating scale Hamilton Depression Rating Scale for Depression - 17-item，HAMD-17 Hamilton Anxiety Scale，HAMA Brief Psychiatric Rating Scale, BPRS 4 items
2.3 EEG and eye movement data collection (baseline, 2nd weekend±7days, 6th weekend±14days, 8th weekend±14days, 12th weekend±14days, Week 14-104 Every 4 weekends ± 14 days)
We collect EEG and eye movement data of patients with major depressive disorder at different point(baseline, 2nd weekend±7days, 6th weekend±14days, 8th weekend±14days, 12th weekend±14days, Week 14-104 Every 4 weekends ± 14 days), and collect EEG and eye movement data of healthy controls during the baseline period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with major depressive disorder | – | Drug: selective serotonin reuptake inhibitors, Device: TMSWe collect data of patients with major depressive disorder at different point (baseline, 2nd weekend±7days, 6th weekend±14days, 8th weekend±14days, 12th weekend±14days, Week 14-104 Every 4 weekends ± 14 days). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Depression is a mental state characterized by persistent low mood, loss of interest and pleasure in daily activities, autonomic disorders and decreased energy, resulting in varying degrees of impairment of social and occupational functioning.
Key inclusion criteria (7 listed)
- Out-patient or in-patient aged 18-65 years (including 18 and 65 years), regardless of gender;
- The Chinese version of the Concise International Neuropsychiatric Interview (M.I.N.I.) 7.0.2 type interview, in line with the DSM-5 Diagnostic criteria for major depressive disorder, either first or recurrent;
- Screening and baseline Hamilton Depression Scale (HAMD-17) Score ≥14;
- No antidepressants were taken for at least 14 days prior to enrollment (patients treated with fluoxetine prior to enrollment should Stop for at least 28 days);
- A single class of antidepressant medication is planned;
Key exclusion criteria (6 listed)
- A current or previous DSM-5 diagnosis of a major mental disorder other than major depressive disorder, Such as neurodevelopmental disorders, neurocognitive disorders, schizophrenia and other psychotic disorders, bipolar disorder Sensory disorder, obsessive disorder, panic disorder, post-traumatic stress disorder, alcohol (or drug) dependence or abuse User and personality disorder;
- depression secondary to an organic mental disorder caused by a systemic disease or a neurological disease Seizures, such as depression caused by hypothyroidism;
- Severe or unstable cardiovascular, respiratory, liver, kidney, endocrine, hematological or other conditions Other systemic diseases were not considered suitable for inclusion in this study.
- During the screening period or baseline period, the investigators considered that the physical examination and laboratory examination of the patients were abnormal and judged to have significant clinical significance Bedsense;
- had received systemic Modified Electric therapy (Modified Electric) 3 months before screening Convulsive Therapy, MECT) or Transcranial Magnetic stimulation (Transcranial Magnetic Stimulation (TMS), Deep Brain Stimulation (DBS), Vagus Nerve Stimulation (VNS);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| selective serotonin reuptake inhibitorsAlso: Psychotherapy and TMSResearch Treatment Drug treatment The patient did not take antidepressant treatment at least 14 days before enrollment (the patients treated with fluoxetine before enrollment should stop using it for at least 28 days). During 8 weeks, all subjects with major depressive disorder received effective dosages of selective serotonin reuptake inhibitors, and all subjects with major depressive disorder were limited to a single class of antidepressants. If the treatment of selective serotonin reuptake inhibitors is not effective after eight weeks, the drugs can be considered for replacement. The drugs for replacement include but are not limited to selective serotonin reuptake inhibitors. Other treatment Settings Psychotherapy and TMS are allowed. The method, frequency, and duration of therapy should be recorded. | Drug | Patients with major depressive disorder |
| TMSTMS are allowed. The method, frequency, and duration of therapy should be recorded. | Device | Patients with major depressive disorder |
Primary outcome
score of Snaith-Hamilton Pleasure Scale, SHAPS
Time frame: baseline
rating scale
Generalized Anxiety Disorder,GAD-7
Time frame: baseline
rating scale
Patient Health Questionnare, PHQ-9
Time frame: baseline
rating scale
Hypomania Check List,HCL-33
Time frame: baseline
rating scale
Sheehan Disability Scale，SDS
Time frame: baseline
rating scale
Childhood Trauma Questionnaire，CTQ
Time frame: baseline
rating scale
Big 5 Personality Questionnaire， B5PQ
Time frame: baseline
rating scale
Dysfunctional Attitude Scale，DAS
Time frame: baseline
rating scale
Interpersonal Reactivity Index-C
Time frame: baseline
rating scale
Scale for Suicide Ideation，SSI
Time frame: baseline
rating scale
Hamilton Depression Rating Scale for Depression - 17-item，HAMD-17
Time frame: baseline
rating scale
Hamilton Anxiety Scale，HAMA
Time frame: baseline
rating scale
Brief Psychiatric Rating Scale, BPRS 4 items
Time frame: baseline
rating scale
score of Snaith-Hamilton Pleasure Scale, SHAPS
Time frame: 2nd weekend±7days,
rating scale
score of Generalized Anxiety Disorder,GAD-7
Time frame: 2nd weekend±7days,
rating scale
score of Patient Health Questionnare, PHQ-9
Time frame: 2nd weekend±7days,
rating scale
score of Hypomania Check List,HCL-33
Time frame: 2nd weekend±7days,
rating scale
score of Sheehan Disability Scale，SDS
Time frame: 2nd weekend±7days,
rating scale
score of Interpersonal Reactivity Index-C
Time frame: 2nd weekend±7days,
rating scale
score of Scale for Suicide Ideation，SSI
Time frame: 2nd weekend±7days,
rating scale
Hamilton Depression Rating Scale for Depression - 17-item，HAMD-17
Time frame: 2nd weekend±7days,
rating scale
Hamilton Anxiety Scale，HAMA
Time frame: 2nd weekend±7days,
rating scale
score of Snaith-Hamilton Pleasure Scale, SHAPS
Time frame: 6th weekend±14days,
rating scale
Generalized Anxiety Disorder,GAD-7
Time frame: 6th weekend±14days,
rating scale
Patient Health Questionnare, PHQ-9
Time frame: 6th weekend±14days,
rating scale
Hypomania Check List,HCL-33
Time frame: 6th weekend±14days,
rating scale
Sheehan Disability Scale，SDS
Time frame: 6th weekend±14days,
rating scale
Interpersonal Reactivity Index-C
Time frame: 6th weekend±14days,
rating scale
Scale for Suicide Ideation，SSI
Time frame: 6th weekend±14days,
rating scale
Hamilton Depression Rating Scale for Depression - 17-item，HAMD-17
Time frame: 6th weekend±14days,
rating scale
Hamilton Anxiety Scale，HAMA
Time frame: 6th weekend±14days,
rating scale
score of Snaith-Hamilton Pleasure Scale, SHAPS
Time frame: 8th weekend±14days,
rating scale
score of Generalized Anxiety Disorder,GAD-7
Time frame: 8th weekend±14days,
rating scale
score of Patient Health Questionnare, PHQ-9
Time frame: 8th weekend±14days,
rating scale
score of Hypomania Check List,HCL-33
Time frame: 8th weekend±14days,
rating scale
score of Sheehan Disability Scale，SDS
Time frame: 8th weekend±14days,
rating scale
score of Interpersonal Reactivity Index-C
Time frame: 8th weekend±14days,
rating scale
score of Scale for Suicide Ideation，SSI
Time frame: 8th weekend±14days,
rating scale
score of Hamilton Depression Rating Scale for Depression - 17-item，HAMD-17
Time frame: 8th weekend±14days,
rating scale
score of Hamilton Anxiety Scale，HAMA
Time frame: 8th weekend±14days,
rating scale
score of Snaith-Hamilton Pleasure Scale, SHAPS
Time frame: 12th weekend±14days,
rating scale
score of Generalized Anxiety Disorder,GAD-7
Time frame: 12th weekend±14days,
rating scale
score of Patient Health Questionnare, PHQ-9
Time frame: 12th weekend±14days,
rating scale
score of Hypomania Check List,HCL-33
Time frame: 12th weekend±14days,
rating scale
score of Sheehan Disability Scale，SDS
Time frame: 12th weekend±14days,
rating scale
score of Interpersonal Reactivity Index-C
Time frame: 12th weekend±14days,
rating scale
score of Scale for Suicide Ideation，SSI
Time frame: 12th weekend±14days,
rating scale
score of Hamilton Depression Rating Scale for Depression - 17-item，HAMD-17
Time frame: 12th weekend±14days,
rating scale
score of Hamilton Anxiety Scale，HAMA
Time frame: 12th weekend±14days,
rating scale
score of Snaith-Hamilton Pleasure Scale, SHAPS
Time frame: Week 14-104 Every 4 weekends ± 14 days
rating scale
Generalized Anxiety Disorder,GAD-7
Time frame: Week 14-104 Every 4 weekends ± 14 days
rating scale
score of Patient Health Questionnare, PHQ-9
Time frame: Week 14-104 Every 4 weekends ± 14 days
rating scale
score of Hypomania Check List,HCL-33
Time frame: Week 14-104 Every 4 weekends ± 14 days
rating scale
score of Sheehan Disability Scale，SDS
Time frame: Week 14-104 Every 4 weekends ± 14 days
rating scale
score of Interpersonal Reactivity Index-C
Time frame: Week 14-104 Every 4 weekends ± 14 days
rating scale
score of Scale for Suicide Ideation，SSI
Time frame: Week 14-104 Every 4 weekends ± 14 days
rating scale
score of Hamilton Depression Rating Scale for Depression - 17-item，HAMD-17
Time frame: Week 14-104 Every 4 weekends ± 14 days
rating scale
score of Hamilton Anxiety Scale，HAMA
Time frame: Week 14-104 Every 4 weekends ± 14 days
rating scale
average power of 4 bands: δ (1-4 Hz)、 θ (4-8 Hz)、 α (8-13 Hz)、 β (13-30 Hz)
Time frame: baseline
EEG features
1.Average duration of EEG microstates 2. The average number of occurrences of EEG microstates per second 3. Average percentage of time covered by EEG microstates 4.the calculation of microstate transition.
Time frame: baseline
EEG features
Connectivity index of full-band brain function network, and connectivity index of each band brain function network
Time frame: baseline
EEG features
EEG features extracted by machine learning
Time frame: baseline
EEG features
average power of 4 bands: δ (1-4 Hz)、 θ (4-8 Hz)、 α (8-13 Hz)、 β (13-30 Hz)
Time frame: 2nd weekend±7days
EEG features
Average duration of EEG microstates 2. The average number of occurrences of EEG microstates per second 3. Average percentage of time covered by EEG microstates 4.the calculation of microstate transition.
Time frame: 2nd weekend±7days
EEG features
Connectivity index of full-band brain function network, and connectivity index of each band brain function network
Time frame: 2nd weekend±7days
EEG features
EEG features extracted by machine learning
Time frame: 2nd weekend±7days
EEG features
average power of 4 bands: δ (1-4 Hz)、 θ (4-8 Hz)、 α (8-13 Hz)、 β (13-30 Hz)
Time frame: 6th weekend±14days
EEG features
1.Average duration of EEG microstates 2. The average number of occurrences of EEG microstates per second 3. Average percentage of time covered by EEG microstates 4.the calculation of microstate transition.
Time frame: 6th weekend±14days
EEG features
Connectivity index of full-band brain function network, and connectivity index of each band brain function network
Time frame: 6th weekend±14days
EEG features
EEG features extracted by machine learning
Time frame: 6th weekend±14days
EEG features
average power of 4 bands: δ (1-4 Hz)、 θ (4-8 Hz)、 α (8-13 Hz)、 β (13-30 Hz)
Time frame: 8th weekend±14days
EEG features
1.Average duration of EEG microstates 2. The average number of occurrences of EEG microstates per second 3. Average percentage of time covered by EEG microstates 4.the calculation of microstate transition.
Time frame: 8th weekend±14days
EEG features
Connectivity index of full-band brain function network, and connectivity index of each band brain function network
Time frame: 8th weekend±14days
EEG features
EEG features extracted by machine learning
Time frame: 8th weekend±14days
EEG features
average power of 4 bands: δ (1-4 Hz)、 θ (4-8 Hz)、 α (8-13 Hz)、 β (13-30 Hz)
Time frame: 12th weekend±14days
EEG features
1.Average duration of EEG microstates 2. The average number of occurrences of EEG microstates per second 3. Average percentage of time covered by EEG microstates 4.the calculation of microstate transition.
Time frame: 12th weekend±14days
EEG features
Connectivity index of full-band brain function network, and connectivity index of each band brain function network
Time frame: 12th weekend±14days
EEG features
EEG features extracted by machine learning
Time frame: 12th weekend±14days
EEG features
average power of 4 bands: δ (1-4 Hz)、 θ (4-8 Hz)、 α (8-13 Hz)、 β (13-30 Hz)
Time frame: Week 14-104 Every 4 weekends ± 14 days
EEG features
1.Average duration of EEG microstates 2. The average number of occurrences of EEG microstates per second 3. Average percentage of time covered by EEG microstates 4.the calculation of microstate transition.
Time frame: Week 14-104 Every 4 weekends ± 14 days
EEG features
Connectivity index of full-band brain function network, and connectivity index of each band brain function network
Time frame: Week 14-104 Every 4 weekends ± 14 days
EEG features
EEG features extracted by machine learning
Time frame: Week 14-104 Every 4 weekends ± 14 days
EEG features
Eye movement index
Time frame: baseline
Collect resting eye movement data and task eye movement data. For eye movement data, features are extracted from blinking, scanning, staring, pupil diameter, initial fixation latency, initial fixation duration, total fixation duration and area of interest and so on.
Eye movement index
Time frame: 2nd weekend±7days
Collect resting eye movement data and task eye movement data. For eye movement data, features are extracted from blinking, scanning, staring, pupil diameter, initial fixation latency, initial fixation duration, total fixation duration and area of interest and so on.
Eye movement index
Time frame: 6th weekend±14days
Collect resting eye movement data and task eye movement data. For eye movement data, features are extracted from blinking, scanning, staring, pupil diameter, initial fixation latency, initial fixation duration, total fixation duration and area of interest and so on.
Eye movement index
Time frame: 8th weekend±14days
Collect resting eye movement data and task eye movement data. For eye movement data, features are extracted from blinking, scanning, staring, pupil diameter, initial fixation latency, initial fixation duration, total fixation duration and area of interest and so on.
Eye movement index
Time frame: 12th weekend±14days
Collect resting eye movement data and task eye movement data. For eye movement data, features are extracted from blinking, scanning, staring, pupil diameter, initial fixation latency, initial fixation duration, total fixation duration and area of interest and so on.
Eye movement index
Time frame: Week 14-104 Every 4 weekends ± 14 days
Collect resting eye movement data and task eye movement data. For eye movement data, features are extracted from blinking, scanning, staring, pupil diameter, initial fixation latency, initial fixation duration, total fixation duration and area of interest and so on.
Eye movement features extracted by machine learning
Time frame: baseline
Eye movement features extracted by machine learning
Eye movement features extracted by machine learning
Time frame: 2nd weekend±7days
Eye movement features extracted by machine learning
Eye movement features extracted by machine learning
Time frame: 6th weekend±14days
Eye movement features extracted by machine learning
Eye movement features extracted by machine learning
Time frame: 8th weekend±14days
Eye movement features extracted by machine learning
Eye movement features extracted by machine learning
Time frame: 12th weekend±14days
Eye movement features extracted by machine learning
Eye movement features extracted by machine learning
Time frame: Week 14-104 Every 4 weekends ± 14 days
Eye movement features extracted by machine learning
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder, run by Sir Run Run Shaw Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
score of Snaith-Hamilton Pleasure Scale, SHAPS (time frame: baseline). The study lists 94 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2023.