Major Depressive DisorderNCT04209166
A Study of Individualized Diagnosis and Treatment for Major Depressive Disorder With Atypical Features
A study testing SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors), SSRIs/SNRIs+Mood Stabilizer and SSRIs/SNRIs+Quetiapine in people with Major Depressive Disorder, run by Shanghai Mental Health Center at 5 sites in China.
Trial summary
The lifetime prevalence of major depressive disorder (MDD) is 10%~20%. Worldwide, nearly 340 million individuals have suffered the torture of depression. World Health Organization has reported that MDD would become the most serious global burden of disease and eventually turn into a public health problem in 2030. Read more about this study
- Who is it for?
- Ages 16 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors), SSRIs/SNRIs+Mood Stabilizer and SSRIs/SNRIs+Quetiapine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 780 participants
- Where
- 5 sitesChina
- Study dates
- 12 Aug 2019to 31 Oct 2022
- Phase
- Interventional
- 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 16 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 16-60 years old;
- Meeting with the criteria of major depressive disorder in the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5;
- Scored 20 or higher on the Hamilton's Depression Scale with 24 items (HAMD-24);
- With enough audio-visual ability and comprehensive ability to accomplish the visits;
- Be necessary and suitable to accept the treatment of antidepressants;
- Scored less than 14 on Hamilton's Anxiety Scale (HAMA) and scored less than 14 on the Hypomania Symptom Checklist-32 (HCL-32);
- With 2 or more atypical symptoms including significant weight gain or increase in appetite, hypersomnia, leaden paralysis, and a long-standing pattern of interpersonal rejection sensitivity that results in significant social or occupational impairment.
Who cannot join
- Severe medical or neurological problems;
- Previous mania or hypomania episodes;
- Female patients who are pregnant, planning to be pregnant or breastfeeding;
- Actively suicide ascertained by research psychiatrist or 3rd item of HAMD scored≥3(suicidality);
- Had ECT, MECT or rTMS in the past 6 months;
- Experienced severe personality disorder, mental retardation, anorexia/bulimia nervosa.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites, 5 recruiting
- Not yet recruiting
Dalian Seventh People's Hospital
Dalian, Liaoning, 116000
Shoufu Xie, MD, 13998622066
- Not yet recruiting
Guangzhou Psychiatric Hospital
Guanzhou, Guangdong, 510000
Guiyun Xu, MD, 18922165291, 13650774898@163.com
- Recruiting
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Daihui Peng, M.D.,Ph.D., 18017311136, pdhsh@126.com
- Not yet recruiting
Wuhan Mental Health Center
Wuhan, Hubei, 430000
Yi Li, MD, 13554013182, psylee@163.com
- Not yet recruiting
Fourth Military Medical University
Xian, Shanxi, 710000
Huaning Wang, MD, 13609161341, 13609161341@163.com
About this study
The lifetime prevalence of major depressive disorder (MDD) is 10%~20%. Worldwide, nearly 340 million individuals have suffered the torture of depression. World Health Organization has reported that MDD would become the most serious global burden of disease and eventually turn into a public health problem in 2030. Varied clinical symptoms, inappropriate treatment, unclear pathogenesis, and lack of recurrent risk early-warning predictors cause a series of clinical problems, such as low diagnostic rate, low effective treatment rate, and high recurrent rate. Hence, this study aims to search multidimensional markers for early diagnosis of MDD, to establish optimized personalized therapy, and to explore sensitive recurrence predictors.
Based on the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), MDD is subdivided into eight different clinical specifiers, one of which the incident rate of MDD with atypical features reaches 30%~38%. However, there is still a lack of meta-evidence for the clinical treatment strategy in MDD with atypical features. And 45.4 percentage of MDD with atypical features convert to bipolar disorder. Therefore, this study will focus on three issues about what's the objective endophenotype in MDD with atypical features, how to select appropriate personalized treatment for MDD with atypical features, what's the predictive biomarker of conversion to bipolar disorder.
Based on the investigators' previous findings, this study will investigate adult depression at a cross-sectional study and a prospective cohort study. Multivariate informatics analysis was performed from three research dimensions (cognitive neuropsychology, metabonomics, and multimodal neuroimaging), including atypical features, "cold/hot" cognition assessment, KP (kynurenine pathway) metabolomics and inflammatory factors, multimodal MRI robust property. Referring guidelines for the diagnosis and treatment of depression and evidence-based medicine evidence, MDD with atypical features are divided into f groups (antidepressants, antidepressants+mood stabilizers, mood stabilizers, treat as usual). Then, the investigators perform follow-up to verify optimized treatment strategies and to explore risk factors of conversion from MDD with atypical features to bipolar disorder. Furthermore, this study performs correlation analysis to analyze cross-omics data, weight coefficient analysis to analyze multidimensional indexes, clustering analysis to analyze multivariate bio-information data, and artificial intelligence technologies (such as pattern recognition, and machine learning) to realize the transformation from medical data to practical transformation. Eventually, this study builds three specific models (the multidimensional early diagnosis models for MDD with atypical features, the optimized personalized therapy model, and the recurrence and conversion risk early-warning model), which form the integrated intelligent platform for multidimensional diagnosis, personalized treatment, recovery management of MDD with atypical features.
- Conditions
- Major Depressive Disorder
- Being tested
- SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors), SSRIs/SNRIs+Mood Stabilizer, SSRIs/SNRIs+Quetiapine, Usual Treatment
- 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.
SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors)Drug
Patients will be treated with Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors.
SSRIs/SNRIs+Mood StabilizerDrug
Patients will be treated with Mood Stabilizer combined with Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors.
SSRIs/SNRIs+QuetiapineDrug
Patients will be treated with Quetiapine combined with Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors.
Usual TreatmentDrug
Patients' treatment will be decided by the clinical doctor.
| Study group | Role | What they receive |
|---|---|---|
| FAD | Experimental | the first-episode major depressive disorder with atypical feature Receives: Drug: SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors); Drug: SSRIs/SNRIs+Mood Stabilizer; Drug: SSRIs/SNRIs+Quetiapine; Drug: Usual Treatment |
| RAD | Experimental | the recurrent major depressive disorder with atypical feature who have been medication-free for no less than 2 weeks Receives: Drug: SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors); Drug: SSRIs/SNRIs+Mood Stabilizer; Drug: SSRIs/SNRIs+Quetiapine; Drug: Usual Treatment |
| BD | No intervention | the depressive episode of bipolar disorder |
| HC | No intervention | healthy control |
What is being measured
The primary outcome is the main question the study is designed to answer.
remission of acute phase
scored 7 or lower on the Hamilton's Depression Scale with 24 items
Measured: 12th week
switch rate
the rate of patients who switch from depression to mania or hypomania during 4-year follow-up
Measured: 4th year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start12 Aug 2019
- Primary completion31 Oct 2022 (estimated)
- Study completion31 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 780 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Air Force Military Medical University, China, Guangzhou Psychiatric Hospital, Dalian Seventh People's Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Shanghai Jiao Tong University School of Medicine
- Responsible party
- Sponsor
- Investigators
- Daihui Peng, MD. PhD., Study chair, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04209166
- Sponsor's protocol ID
- CRC2018ZD05
- Status last verified
- Oct 2019
- First submitted
- 16 Dec 2019
- Last updated
- 23 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhou R, Zhang H, He S, Li Y, Xu G, Huang J, Wang H, Wang Q, Li B, Wang X, Chen N, Li F, Li X, Liu M, Peng D. A Study of Individualized Diagnosis and Treatment for Depression with Atypical Features (iDoT-AFD): study protocol for a randomized clinical trial and prognosis study. Trials. 2023 May 4;24(1):308. doi: 10.1186/s13063-023-07317-w.
PubMed 37143128
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Individualized Diagnosis and Treatment for Major Depressive Disorder With Atypical Features
- ClinicalTrials.gov ID
- NCT04209166
- Acronym / sponsor ID
- CRC2018ZD05
- Conditions
- Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 780 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Collaborators
- Air Force Military Medical University, China, Guangzhou Psychiatric Hospital, Dalian Seventh People's Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Shanghai Jiao Tong University School of Medicine
- Study start
- 12 Aug 2019 (actual)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 23 Dec 2019 (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 lifetime prevalence of major depressive disorder (MDD) is 10%~20%. Worldwide, nearly 340 million individuals have suffered the torture of depression. World Health Organization has reported that MDD would become the most serious global burden of disease and eventually turn into a public health problem in 2030. Varied clinical symptoms, inappropriate treatment, unclear pathogenesis, and lack of recurrent risk early-warning predictors cause a series of clinical problems, such as low diagnostic rate, low effective treatment rate, and high recurrent rate. Hence, this study aims to search multidimensional markers for early diagnosis of MDD, to establish optimized personalized therapy, and to explore sensitive recurrence predictors.
Based on the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), MDD is subdivided into eight different clinical specifiers, one of which the incident rate of MDD with atypical features reaches 30%~38%. However, there is still a lack of meta-evidence for the clinical treatment strategy in MDD with atypical features. And 45.4 percentage of MDD with atypical features convert to bipolar disorder. Therefore, this study will focus on three issues about what's the objective endophenotype in MDD with atypical features, how to select appropriate personalized treatment for MDD with atypical features, what's the predictive biomarker of conversion to bipolar disorder.
Based on the investigators' previous findings, this study will investigate adult depression at a cross-sectional study and a prospective cohort study. Multivariate informatics analysis was performed from three research dimensions (cognitive neuropsychology, metabonomics, and multimodal neuroimaging), including atypical features, "cold/hot" cognition assessment, KP (kynurenine pathway) metabolomics and inflammatory factors, multimodal MRI robust property. Referring guidelines for the diagnosis and treatment of depression and evidence-based medicine evidence, MDD with atypical features are divided into f groups (antidepressants, antidepressants+mood stabilizers, mood stabilizers, treat as usual). Then, the investigators perform follow-up to verify optimized treatment strategies and to explore risk factors of conversion from MDD with atypical features to bipolar disorder. Furthermore, this study performs correlation analysis to analyze cross-omics data, weight coefficient analysis to analyze multidimensional indexes, clustering analysis to analyze multivariate bio-information data, and artificial intelligence technologies (such as pattern recognition, and machine learning) to realize the transformation from medical data to practical transformation. Eventually, this study builds three specific models (the multidimensional early diagnosis models for MDD with atypical features, the optimized personalized therapy model, and the recurrence and conversion risk early-warning model), which form the integrated intelligent platform for multidimensional diagnosis, personalized treatment, recovery management of MDD with atypical features.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| FAD | Experimental | Drug: SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors), Drug: SSRIs/SNRIs+Mood Stabilizer, Drug: SSRIs/SNRIs+Quetiapine, Drug: Usual Treatmentthe first-episode major depressive disorder with atypical feature |
| RAD | Experimental | Drug: SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors), Drug: SSRIs/SNRIs+Mood Stabilizer, Drug: SSRIs/SNRIs+Quetiapine, Drug: Usual Treatmentthe recurrent major depressive disorder with atypical feature who have been medication-free for no less than 2 weeks |
| BD | No intervention | –the depressive episode of bipolar disorder |
| HC | No intervention | –healthy control |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 16-60 years old;
- Meeting with the criteria of major depressive disorder in the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5;
- Scored 20 or higher on the Hamilton's Depression Scale with 24 items (HAMD-24);
- With enough audio-visual ability and comprehensive ability to accomplish the visits;
- Be necessary and suitable to accept the treatment of antidepressants;
Key exclusion criteria (6 listed)
- Severe medical or neurological problems;
- Previous mania or hypomania episodes;
- Female patients who are pregnant, planning to be pregnant or breastfeeding;
- Actively suicide ascertained by research psychiatrist or 3rd item of HAMD scored≥3(suicidality);
- Had ECT, MECT or rTMS in the past 6 months;
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 |
|---|---|---|
| SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors)Patients will be treated with Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors. | Drug | FAD, RAD |
| SSRIs/SNRIs+Mood StabilizerPatients will be treated with Mood Stabilizer combined with Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors. | Drug | FAD, RAD |
| SSRIs/SNRIs+QuetiapinePatients will be treated with Quetiapine combined with Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors. | Drug | FAD, RAD |
| Usual TreatmentPatients' treatment will be decided by the clinical doctor. | Drug | FAD, RAD |
Primary outcome
remission of acute phase
Time frame: 12th week
scored 7 or lower on the Hamilton's Depression Scale with 24 items
switch rate
Time frame: 4th year
the rate of patients who switch from depression to mania or hypomania during 4-year follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2019.
- Derived from this study: PubMed 37143128Zhou R, Zhang H, He S, Li Y, Xu G, Huang J, Wang H, Wang Q, Li B, Wang X, Chen N, Li F, Li X, Liu M, Peng D. A Study of Individualized Diagnosis and Treatment for Depression with Atypical Features (iDoT-AFD): study protocol for a randomized clinical trial and prognosis study. Trials. 2023 May 4;24(1):308. doi: 10.1186/s13063-023-07317-w.
- Individual participant dataSharing planned: Undecided
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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.
Daihui Peng, MD. PhD. study chair
Shanghai Mental Health Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors), SSRIs/SNRIs+Mood Stabilizer and SSRIs/SNRIs+Quetiapine in people with Major Depressive Disorder, run by Shanghai Mental Health Center at 5 sites 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 23 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 Daihui Peng, MD. PhD. (18017311136, pdhsh@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
remission of acute phase (time frame: 12th week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04209166, which also lists 1 linked publication.
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 23 Dec 2019.