A Study of Diagnosis and Treatment of Depression Based on Biological Evidence of Dopamine Reward Pathway
Primary Purpose
Diagnosis and Treatment of Depression
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
risperidone
aripiprazole
bupropion
Sponsored by
About this trial
This is an interventional treatment trial for Diagnosis and Treatment of Depression
Eligibility Criteria
Inclusion Criteria:
- patients unresponsive to SSRI antidepressant treatment, first-degree relatives (parents or siblings) of depressed patients, schizophrenia, Parkinson's disease with and without depression, and healthy controls
Exclusion Criteria:
- Major physical illness; other DSM-IV axis I mental illness; personality disorder, mental retardation; drug and/or alcohol dependence; pregnant or lactating women; MRI examination contraindications.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
bupropion
risperidone
aripiprazole
Arm Description
receive bupropion
receive risperidone
receive aripiprazole
Outcomes
Primary Outcome Measures
Hamilton Rating Scale for Depression
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03148509
Brief Title
A Study of Diagnosis and Treatment of Depression Based on Biological Evidence of Dopamine Reward Pathway
Official Title
Clinical Psychopharmacology Division Institute of Mental Health, Peking University
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2017 (Anticipated)
Primary Completion Date
December 30, 2019 (Anticipated)
Study Completion Date
December 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will recruit depressed patients unresponsive to selective serotonin reuptake inhibitor antidepressant treatment, first-degree relatives (parents or siblings) of depressed patients, schizophrenia, Parkinson's disease with and without depression, and healthy controls. The subjects need to complete the brain positron emission tomography/magnetic resonance examination, stress assessment, genetic testing, clinical evaluation and neuropsychological tests. Using the data, this study aimed to identify the abnormalities of reward circuit of depression and its differences with other diseases, and its abnormalities in first-degree relatives of depression. The depressed patients who were ineffective in treatment with selective serotonin reuptake inhibitor antidepressants were then given combined medication with dopamine receptor-mediated drugs, including dopamine transporter inhibitor - bupropion, D2 receptor antagonist - risperidone, or D2 receptor partial agonist - aripiprazole, to examine the regulation of dopamine pathway and its relationship with the therapeutic effect. Through the above work, we will provide new evidence for integrating the biological evidence of dopamine reward pathway into the clinical practice of depression.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diagnosis and Treatment of Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
bupropion
Arm Type
Experimental
Arm Description
receive bupropion
Arm Title
risperidone
Arm Type
Experimental
Arm Description
receive risperidone
Arm Title
aripiprazole
Arm Type
Experimental
Arm Description
receive aripiprazole
Intervention Type
Drug
Intervention Name(s)
risperidone
Intervention Description
DA receptor-mediated drugs
Intervention Type
Drug
Intervention Name(s)
aripiprazole
Intervention Description
DA receptor-mediated drugs
Intervention Type
Drug
Intervention Name(s)
bupropion
Intervention Description
DA receptor-mediated drugs
Primary Outcome Measure Information:
Title
Hamilton Rating Scale for Depression
Time Frame
8 weeks
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
patients unresponsive to SSRI antidepressant treatment, first-degree relatives (parents or siblings) of depressed patients, schizophrenia, Parkinson's disease with and without depression, and healthy controls
Exclusion Criteria:
Major physical illness; other DSM-IV axis I mental illness; personality disorder, mental retardation; drug and/or alcohol dependence; pregnant or lactating women; MRI examination contraindications.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ji-Tao Li, MD
Phone
010-62723742
Email
ljt_102124@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of Diagnosis and Treatment of Depression Based on Biological Evidence of Dopamine Reward Pathway
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