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A Study of Individualized Diagnosis and Treatment for Major Depressive Disorder With Atypical Features

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04209166
Recruitment Status : Recruiting
First Posted : December 23, 2019
Last Update Posted : December 23, 2019
Sponsor:
Collaborators:
Fourth Military Medical University
Guangzhou Psychiatric Hospital
Dalian Seventh People's Hospital
Wuhan Union Hospital, China
Shanghai Jiao Tong University School of Medicine
Information provided by (Responsible Party):
Shanghai Mental Health Center

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.


Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors) Drug: SSRIs/SNRIs+Mood Stabilizer Drug: SSRIs/SNRIs+Quetiapine Drug: Usual Treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 780 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Study of Individualized Diagnosis and Treatment for Major Depressive Disorder With Atypical Features
Actual Study Start Date : August 12, 2019
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : October 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FAD
the first-episode major depressive disorder with atypical feature
Drug: 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: SSRIs/SNRIs+Mood Stabilizer
Patients will be treated with Mood Stabilizer combined with Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors.

Drug: SSRIs/SNRIs+Quetiapine
Patients will be treated with Quetiapine combined with Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors.

Drug: Usual Treatment
Patients' treatment will be decided by the clinical doctor.

Experimental: RAD
the recurrent major depressive disorder with atypical feature who have been medication-free for no less than 2 weeks
Drug: 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: SSRIs/SNRIs+Mood Stabilizer
Patients will be treated with Mood Stabilizer combined with Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors.

Drug: SSRIs/SNRIs+Quetiapine
Patients will be treated with Quetiapine combined with Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors.

Drug: Usual Treatment
Patients' treatment will be decided by the clinical doctor.

No Intervention: BD
the depressive episode of bipolar disorder
No Intervention: HC
healthy control



Primary Outcome Measures :
  1. remission of acute phase [ Time Frame: 12th week ]
    scored 7 or lower on the Hamilton's Depression Scale with 24 items

  2. switch rate [ Time Frame: 4th year ]
    the rate of patients who switch from depression to mania or hypomania during 4-year follow-up



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 16-60 years old;
  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:

  1. Severe medical or neurological problems;
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04209166


Contacts
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Contact: Daihui Peng, MD. PhD. 18017311136 pdhsh@126.com

Locations
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China, Guangdong
Guangzhou Psychiatric Hospital Not yet recruiting
Guanzhou, Guangdong, China, 510000
Contact: Guiyun Xu, MD    18922165291    13650774898@163.com   
China, Hubei
Wuhan Mental Health Center Not yet recruiting
Wuhan, Hubei, China, 430000
Contact: Yi Li, MD    13554013182    psylee@163.com   
China, Liaoning
Dalian Seventh People's Hospital Not yet recruiting
Dalian, Liaoning, China, 116000
Contact: Shoufu Xie, MD    13998622066      
China, Shanghai
Shanghai Mental Health Center Recruiting
Shanghai, Shanghai, China, 200030
Contact: Daihui Peng, M.D.,Ph.D.    18017311136    pdhsh@126.com   
China, Shanxi
Fourth Military Medical University Not yet recruiting
Xian, Shanxi, China, 710000
Contact: Huaning Wang, MD    13609161341    13609161341@163.com   
Sponsors and Collaborators
Shanghai Mental Health Center
Fourth Military Medical University
Guangzhou Psychiatric Hospital
Dalian Seventh People's Hospital
Wuhan Union Hospital, China
Shanghai Jiao Tong University School of Medicine
Investigators
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Study Chair: Daihui Peng, MD. PhD. Shanghai Mental Health Center
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Responsible Party: Shanghai Mental Health Center
ClinicalTrials.gov Identifier: NCT04209166    
Other Study ID Numbers: CRC2018ZD05
First Posted: December 23, 2019    Key Record Dates
Last Update Posted: December 23, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Norepinephrine
Quetiapine Fumarate
Serotonin
Serotonin Uptake Inhibitors
Serotonin and Noradrenaline Reuptake Inhibitors
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators