A Study of Individualized Diagnosis and Treatment for Major Depressive Disorder With Atypical Features
1 other identifier
interventional
780
1 country
5
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable major-depressive-disorder
Started Aug 2019
Typical duration for not_applicable major-depressive-disorder
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 12, 2019
CompletedFirst Submitted
Initial submission to the registry
December 16, 2019
CompletedFirst Posted
Study publicly available on registry
December 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2022
CompletedDecember 23, 2019
October 1, 2019
3.2 years
December 16, 2019
December 20, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
remission of acute phase
scored 7 or lower on the Hamilton's Depression Scale with 24 items
12th week
switch rate
the rate of patients who switch from depression to mania or hypomania during 4-year follow-up
4th year
Study Arms (4)
FAD
EXPERIMENTALthe first-episode major depressive disorder with atypical feature
RAD
EXPERIMENTALthe recurrent major depressive disorder with atypical feature who have been medication-free for no less than 2 weeks
BD
NO INTERVENTIONthe depressive episode of bipolar disorder
HC
NO INTERVENTIONhealthy control
Interventions
Patients will be treated with Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors.
Patients will be treated with Mood Stabilizer combined with Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors.
Patients will be treated with Quetiapine combined with Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shanghai Mental Health Centerlead
- Air Force Military Medical University, Chinacollaborator
- Guangzhou Psychiatric Hospitalcollaborator
- Dalian Seventh People's Hospitalcollaborator
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technologycollaborator
- Shanghai Jiao Tong University School of Medicinecollaborator
Study Sites (5)
Guangzhou Psychiatric Hospital
Guanzhou, Guangdong, 510000, China
Wuhan Mental Health Center
Wuhan, Hubei, 430000, China
Dalian Seventh People's Hospital
Dalian, Liaoning, 116000, China
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030, China
Fourth Military Medical University
Xian, Shanxi, 710000, China
Related Publications (1)
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.
PMID: 37143128DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Daihui Peng, MD. PhD.
Shanghai Mental Health Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2019
First Posted
December 23, 2019
Study Start
August 12, 2019
Primary Completion
October 31, 2022
Study Completion
October 31, 2022
Last Updated
December 23, 2019
Record last verified: 2019-10