A Study of Individualized Diagnosis and Treatment for Major Depressive Disorder With Atypical Features
NCT ID: NCT04209166
Last Updated: 2019-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
780 participants
INTERVENTIONAL
2019-08-12
2022-10-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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FAD
the first-episode major depressive disorder with atypical feature
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.
SSRIs/SNRIs+Mood Stabilizer
Patients will be treated with Mood Stabilizer combined with Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors.
SSRIs/SNRIs+Quetiapine
Patients will be treated with Quetiapine combined with Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors.
Usual Treatment
Patients' treatment will be decided by the clinical doctor.
RAD
the recurrent major depressive disorder with atypical feature who have been medication-free for no less than 2 weeks
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.
SSRIs/SNRIs+Mood Stabilizer
Patients will be treated with Mood Stabilizer combined with Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors.
SSRIs/SNRIs+Quetiapine
Patients will be treated with Quetiapine combined with Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors.
Usual Treatment
Patients' treatment will be decided by the clinical doctor.
BD
the depressive episode of bipolar disorder
No interventions assigned to this group
HC
healthy control
No interventions assigned to this group
Interventions
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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.
SSRIs/SNRIs+Mood Stabilizer
Patients will be treated with Mood Stabilizer combined with Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors.
SSRIs/SNRIs+Quetiapine
Patients will be treated with Quetiapine combined with Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors.
Usual Treatment
Patients' treatment will be decided by the clinical doctor.
Eligibility Criteria
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Inclusion Criteria
2. Meeting with the criteria of major depressive disorder in the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5;
3. Scored 20 or higher on the Hamilton's Depression Scale with 24 items (HAMD-24);
4. With enough audio-visual ability and comprehensive ability to accomplish the visits;
5. Be necessary and suitable to accept the treatment of antidepressants;
6. Scored less than 14 on Hamilton's Anxiety Scale (HAMA) and scored less than 14 on the Hypomania Symptom Checklist-32 (HCL-32);
7. 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.
Exclusion Criteria
2. Previous mania or hypomania episodes;
3. Female patients who are pregnant, planning to be pregnant or breastfeeding;
4. Actively suicide ascertained by research psychiatrist or 3rd item of HAMD scored≥3(suicidality);
5. Had ECT, MECT or rTMS in the past 6 months;
6. Experienced severe personality disorder, mental retardation, anorexia/bulimia nervosa.
16 Years
60 Years
ALL
Yes
Sponsors
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Air Force Military Medical University, China
OTHER
Guangzhou Psychiatric Hospital
OTHER_GOV
Dalian Seventh People's Hospital
OTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Shanghai Jiao Tong University School of Medicine
OTHER
Shanghai Mental Health Center
OTHER
Responsible Party
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Principal Investigators
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Daihui Peng, MD. PhD.
Role: STUDY_CHAIR
Shanghai Mental Health Center
Locations
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Guangzhou Psychiatric Hospital
Guanzhou, Guangdong, China
Wuhan Mental Health Center
Wuhan, Hubei, China
Dalian Seventh People's Hospital
Dalian, Liaoning, China
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China
Fourth Military Medical University
Xian, Shanxi, China
Countries
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Central Contacts
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Facility Contacts
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Guiyun Xu, MD
Role: primary
Yi Li, MD
Role: primary
Shoufu Xie, MD
Role: primary
Daihui Peng, M.D.,Ph.D.
Role: primary
Huaning Wang, MD
Role: primary
References
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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.
Other Identifiers
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CRC2018ZD05
Identifier Type: -
Identifier Source: org_study_id