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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
Peking University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diagnosis and Treatment of Depression

Eligibility Criteria

15 Years - 55 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    May 8, 2017
    Last Updated
    May 10, 2017
    Sponsor
    Peking University
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    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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