Major Depressive DisorderNCT05889234
Multimodal Magnetic Resonance Imaging-based Study of Electroconvulsive Efficacy Prediction in Adolescents With Depression: a Multicenter Prospective Cohort Study
An observational study of Major Depressive Disorder and Magnetic Resonance Imaging, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
The aim of this project is to investigate the multimodal magnetic resonance brain imaging changes in adolescents with major depressive disorder (MDD) before and after electroconvulsive therapy. Development of a predictive model for the efficacy of electroconvulsive therapy in adolescent MDD. Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder, Magnetic Resonance Imaging, Electroconvulsive Therapy
- What is being tested?
- Modified Electroconvulsive Therapy and Conventional pharmacotherapy
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 6 Nov 2023to 1 Jan 2026
- 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 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patients accepted for ECT or medication treatment in the inpatient adolescent MDD patients. According to treatment modality in two groups, as follows: Group 1 (modified electroconvulsive therapy (MECT) ,n=60); Group 2 (Non-modified electroconvulsive therapy(Non-MECT), n=60). Each enrolled participant in group 1 will undergo an index course of MECT, following standard clinical care. Group 2 will receive conventional drug therapy. At the same time, a healthy control group (n=60) will be recruited.
Who may be able to join
None listed.
Who cannot join
- Presence or previous serious medical, neurological or psychiatric illness.
- Patients with a history of substance or drug abuse.
- Contraindications to MRI.
- Lactating women or pregnant women.
- Left-handedness.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Province, 400000
Xinyu Zhou, Doctor of Psychiatry, 15823996993, zhouxinyu@cqmu.edu.cn
About this study
The aim of this project is to investigate the multimodal magnetic resonance brain imaging changes in adolescents with major depressive disorder (MDD) before and after electroconvulsive therapy. Development of a predictive model for the efficacy of electroconvulsive therapy in adolescent MDD.
Read the detailed description
This is a multicenter, prospective, observational study. We will divide the adolescent MDD patients into two groups according to the treatment modality as follows: Group 1 (Modified Electroconvulsive Therapy (MECT), n=60); Group 2 (Non-Modified Electroconvulsive Therapy (Non-MECT), n=60). Patients in group 1 will be treated with MECT according to standard clinical care. Group 2 will receive conventional drug therapy. A healthy control group (n=60) will also be recruited.
The most modern MRI sequences examining brain structure and function are used at 4 time points: at baseline (just before MECT series), the second examination (just after MECT series) and the third and forth (follow-up) examination (3 and 6 months after MECT series). Blood, urine and feces samples and the evaluation of clinical effect and side-effects to MECT are performed at the same time points.
The primary outcome for the treatment phase is the treatment remission rate and response rate. The secondary outcomes included: symptom scale, Quality of life, Sleep therapy, Symptoms of anxiety, Rumination and safety assessment.
- Being tested
- Modified Electroconvulsive Therapy, Conventional pharmacotherapy
- Keywords
- adolescent MDD, MECT, Multimodal MRI
- 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.
Modified Electroconvulsive TherapyDevice
MECT is performed using the Thymatron System IV (Somatics LLC, LakeBluff, IL, USA) electroconvulsive therapy (ECT) machine. Prior to ECT, all patients undergo laboratory tests such as routine blood, liver, kidney and thyroid function and an ECG and remain fasted for 12 hours. Initial treatment power is considered by age: percentage of power = age x 0.7. Stimulation power is adjusted according to seizure duration. If the seizure duration is less than 25 seconds, the energy is increased by 5% in the subsequent treatments. Anaesthesia and muscle relaxation were administered with propofol (1.5-2 mg/kg) and succinylcholine (0.5-1 mg/kg), respectively, and subjects were awakened after ECT treatment and adverse effects, such as subjective memory impairment, headache or nausea/vomiting, were recorded. Frequency of ECT treatment: 3-4 times per week for a total of 6-8 sessions
Conventional pharmacotherapyDrug
Conventional pharmacotherapy: SSRIs including fluoxetine, paroxetine, sertraline, cetinopram, fluvoxamine, vortioxetine, escitalopram; SNRIs including venlafaxine, duloxetine; NaSSA including mirtazapine; other antidepressants including trazodone, bupropion, agomelatine; potentiators including aripiprazole, olanzapine, quetiapine, risperidone.
| Study group | Role | What they receive |
|---|---|---|
| Modified electroconvulsive therapy group | The adolescent MDD receiving modified electroconvulsive therapy and conventional medication. Receives: Device: Modified Electroconvulsive Therapy; Drug: Conventional pharmacotherapy | |
| Non-modified electroconvulsive therapy group | The adolescent MDD receiving only conventional medication. Receives: Drug: Conventional pharmacotherapy | |
| Healthy controls group | Healthy adolescents. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in CDRS-R (Children's Depression Rating Scale, Revised) scores
Clinical response (≥ 50% reduction in CDRS-R scores from baseline).
Measured: The treatment period was baseline, 2-4 weeks. The follow-up period was 1 month, 3 months, 6 months.
Secondary outcomes (17)
Changes in BDI (Beck's Depression Inventory) scores
The severity of depression symptom.
Measured: The treatment period was baseline, 2-4 weeks. The follow-up period was 1 month, 3 months, 6 months.
Changes in SCARED (Screen for Child Anxiety Related Disorders) scores
The severity of Anxiety symptom.
Measured: Baseline of treatment period, 2-4 weeks; The follow-up period was 3 months, 6 months
Changes in suicide risk on C-SSRS (Columbia Suicide Severity Rating Scale) scores
The severity of the suicide risk.
Measured: Baseline of treatment period, 2-4 weeks; The follow-up period was 3 months, 6 months
Changes in PSQI (Pittsburgh Sleep Quality Index) scores
Measures of sleep status.
Measured: Baseline of treatment period, 2-4 weeks; The follow-up period was 3 months, 6 months
Changes in PedsQL4.0 (The Pediatric Quality of Life Inventory 4.0) scores
Measures of children's quality of life.
Measured: Baseline of treatment period, 2-4 weeks; The follow-up period was 3 months, 6 months
Changes in CGI-S (Clinical Global Impressions-Severity Scales) scores
Measures of clinical impression severity.
Measured: Baseline of treatment period, 2-4 weeks
Changes in CGI-I (Clinical Global Impressions-Improvement Scales) scores
Measures of clinical general Impression scale.
Measured: The treatment period was 2-4 weeks
Changes in RSS (Ruminative Responses Scale) scores
Measures of negative thinking.
Measured: Baseline of treatment period, 2-4 weeks; The follow-up period was 3 months, 6 months
Assessment of CTQ（Childhood Trauma Questionnaire）
Measures of childhood trauma.
Measured: Baseline of treatment period
Assessment of OB/VQ（Olweus Bully/Victim Questionnaire）
Measures of bully/victim problems.
Measured: Baseline of treatment period
Changes in AE（Adverse Event）Scale
Measures of any untoward medical orrurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment.
Measured: The treatment period was 2-4 weeks; The follow-up period was 1 month, 3 months, 6 months.
Assessment of SAE（Serious Adverse Event）Scale
Measures of adverse medical events.
Measured: The treatment period was 2-4 weeks; The follow-up period was 1 month, 3 months, 6 months.
Changes in THINC-it
Measures of cognition function.
Measured: Baseline of treatment period, 2-4 weeks; The follow-up period was 3 months, 6 months
Changes in functional MRI
Resting state MRI, measurement of functional connectivity.
Measured: Baseline of treatment period, 2-4 weeks; The follow-up period was 3 months, 6 months
Changes in structural MRI T1 and T2
Measures of brain structure.
Measured: Baseline of treatment period, 2-4 weeks; The follow-up period was 3 months, 6 months
Changes in Cerebral Blood Flow
Estimated by Arterial Spin Labeling MRI.
Measured: Baseline of treatment period, 2-4 weeks; The follow-up period was 3 months, 6 months
Changes in concentration of Glu and GABA in ACC
MR Spectroscopy og the ACC, measures of neuronal integrity.
Measured: Baseline of treatment period, 2-4 weeks; The follow-up period was 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start6 Nov 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Jan 2026 (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 First Affiliated Hospital of Chongqing Medical UniversityThe 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
- 180 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The Second Affiliated Hospital of Chongqing Medical University, Second Xiangya Hospital of Central South University
- Responsible party
- Principal investigator, Xinyu Zhou, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05889234
- Sponsor's protocol ID
- 1stChongqingMUZXY
- Status last verified
- Sep 2023
- First submitted
- 26 May 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Magnetic Resonance Imaging-based Study of Electroconvulsive Efficacy Prediction in Adolescents With Depression: a Multicenter Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05889234
- Acronym / sponsor ID
- 1stChongqingMUZXY
- Keywords
- adolescent MDD, MECT, Multimodal MRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Collaborators
- The Second Affiliated Hospital of Chongqing Medical University, Second Xiangya Hospital of Central South University
- Study start
- 6 Nov 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 5 Jun 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.
The aim of this project is to investigate the multimodal magnetic resonance brain imaging changes in adolescents with major depressive disorder (MDD) before and after electroconvulsive therapy. Development of a predictive model for the efficacy of electroconvulsive therapy in adolescent MDD.
Detailed description
This is a multicenter, prospective, observational study. We will divide the adolescent MDD patients into two groups according to the treatment modality as follows: Group 1 (Modified Electroconvulsive Therapy (MECT), n=60); Group 2 (Non-Modified Electroconvulsive Therapy (Non-MECT), n=60). Patients in group 1 will be treated with MECT according to standard clinical care. Group 2 will receive conventional drug therapy. A healthy control group (n=60) will also be recruited.
The most modern MRI sequences examining brain structure and function are used at 4 time points: at baseline (just before MECT series), the second examination (just after MECT series) and the third and forth (follow-up) examination (3 and 6 months after MECT series). Blood, urine and feces samples and the evaluation of clinical effect and side-effects to MECT are performed at the same time points.
The primary outcome for the treatment phase is the treatment remission rate and response rate. The secondary outcomes included: symptom scale, Quality of life, Sleep therapy, Symptoms of anxiety, Rumination and safety assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Modified electroconvulsive therapy group | – | Device: Modified Electroconvulsive Therapy, Drug: Conventional pharmacotherapyThe adolescent MDD receiving modified electroconvulsive therapy and conventional medication. |
| Non-modified electroconvulsive therapy group | – | Drug: Conventional pharmacotherapyThe adolescent MDD receiving only conventional medication. |
| Healthy controls group | – | –Healthy adolescents. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients accepted for ECT or medication treatment in the inpatient adolescent MDD patients. According to treatment modality in two groups, as follows: Group 1 (modified electroconvulsive therapy (MECT) ,n=60); Group 2 (Non-modified electroconvulsive therapy(Non-MECT), n=60). Each enrolled participant in group 1 will undergo an index course of MECT, following standard clinical care. Group 2 will receive conventional drug therapy. At the same time, a healthy control group (n=60) will be recruited.
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Presence or previous serious medical, neurological or psychiatric illness.
- Patients with a history of substance or drug abuse.
- Contraindications to MRI.
- Lactating women or pregnant women.
- Left-handedness.
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 |
|---|---|---|
| Modified Electroconvulsive TherapyMECT is performed using the Thymatron System IV (Somatics LLC, LakeBluff, IL, USA) electroconvulsive therapy (ECT) machine. Prior to ECT, all patients undergo laboratory tests such as routine blood, liver, kidney and thyroid function and an ECG and remain fasted for 12 hours. Initial treatment power is considered by age: percentage of power = age x 0.7. Stimulation power is adjusted according to seizure duration. If the seizure duration is less than 25 seconds, the energy is increased by 5% in the subsequent treatments. Anaesthesia and muscle relaxation were administered with propofol (1.5-2 mg/kg) and succinylcholine (0.5-1 mg/kg), respectively, and subjects were awakened after ECT treatment and adverse effects, such as subjective memory impairment, headache or nausea/vomiting, were recorded. Frequency of ECT treatment: 3-4 times per week for a total of 6-8 sessions | Device | Modified electroconvulsive therapy group |
| Conventional pharmacotherapyConventional pharmacotherapy: SSRIs including fluoxetine, paroxetine, sertraline, cetinopram, fluvoxamine, vortioxetine, escitalopram; SNRIs including venlafaxine, duloxetine; NaSSA including mirtazapine; other antidepressants including trazodone, bupropion, agomelatine; potentiators including aripiprazole, olanzapine, quetiapine, risperidone. | Drug | Modified electroconvulsive therapy group, Non-modified electroconvulsive therapy group |
Primary outcome
Changes in CDRS-R (Children's Depression Rating Scale, Revised) scores
Time frame: The treatment period was baseline, 2-4 weeks. The follow-up period was 1 month, 3 months, 6 months.
Clinical response (≥ 50% reduction in CDRS-R scores from baseline).
17 secondary outcomes
Changes in BDI (Beck's Depression Inventory) scores
Time frame: The treatment period was baseline, 2-4 weeks. The follow-up period was 1 month, 3 months, 6 months.
Changes in SCARED (Screen for Child Anxiety Related Disorders) scores
Time frame: Baseline of treatment period, 2-4 weeks; The follow-up period was 3 months, 6 months
Changes in suicide risk on C-SSRS (Columbia Suicide Severity Rating Scale) scores
Time frame: Baseline of treatment period, 2-4 weeks; The follow-up period was 3 months, 6 months
Changes in PSQI (Pittsburgh Sleep Quality Index) scores
Time frame: Baseline of treatment period, 2-4 weeks; The follow-up period was 3 months, 6 months
Changes in PedsQL4.0 (The Pediatric Quality of Life Inventory 4.0) scores
Time frame: Baseline of treatment period, 2-4 weeks; The follow-up period was 3 months, 6 months
Changes in CGI-S (Clinical Global Impressions-Severity Scales) scores
Time frame: Baseline of treatment period, 2-4 weeks
Changes in CGI-I (Clinical Global Impressions-Improvement Scales) scores
Time frame: The treatment period was 2-4 weeks
Changes in RSS (Ruminative Responses Scale) scores
Time frame: Baseline of treatment period, 2-4 weeks; The follow-up period was 3 months, 6 months
Assessment of CTQ（Childhood Trauma Questionnaire）
Time frame: Baseline of treatment period
Assessment of OB/VQ（Olweus Bully/Victim Questionnaire）
Time frame: Baseline of treatment period
Changes in AE（Adverse Event）Scale
Time frame: The treatment period was 2-4 weeks; The follow-up period was 1 month, 3 months, 6 months.
Assessment of SAE（Serious Adverse Event）Scale
Time frame: The treatment period was 2-4 weeks; The follow-up period was 1 month, 3 months, 6 months.
Changes in THINC-it
Time frame: Baseline of treatment period, 2-4 weeks; The follow-up period was 3 months, 6 months
Changes in functional MRI
Time frame: Baseline of treatment period, 2-4 weeks; The follow-up period was 3 months, 6 months
Changes in structural MRI T1 and T2
Time frame: Baseline of treatment period, 2-4 weeks; The follow-up period was 3 months, 6 months
Changes in Cerebral Blood Flow
Time frame: Baseline of treatment period, 2-4 weeks; The follow-up period was 3 months, 6 months
Changes in concentration of Glu and GABA in ACC
Time frame: Baseline of treatment period, 2-4 weeks; The follow-up period was 3 months, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 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.
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 and Magnetic Resonance Imaging, run by First Affiliated Hospital of Chongqing Medical University 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 0 inclusion and 5 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 28 Sep 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?
Contact Xinyu Zhou (15823996993, zhouxinyu@cqmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in CDRS-R (Children's Depression Rating Scale, Revised) scores (time frame: The treatment period was baseline, 2-4 weeks. The follow-up period was 1 month, 3 months, 6 months.). 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 28 Sep 2023.