- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03148509
A Study of Diagnosis and Treatment of Depression Based on Biological Evidence of Dopamine Reward Pathway
May 10, 2017 updated by: Si Tianmei, Peking University
Clinical Psychopharmacology Division Institute of Mental Health, Peking University
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
300
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 55 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: bupropion
receive bupropion
|
DA receptor-mediated drugs
|
Experimental: risperidone
receive risperidone
|
DA receptor-mediated drugs
|
Experimental: aripiprazole
receive aripiprazole
|
DA receptor-mediated drugs
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hamilton Rating Scale for Depression
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
June 1, 2017
Primary Completion (Anticipated)
December 30, 2019
Study Completion (Anticipated)
December 30, 2019
Study Registration Dates
First Submitted
May 8, 2017
First Submitted That Met QC Criteria
May 9, 2017
First Posted (Actual)
May 11, 2017
Study Record Updates
Last Update Posted (Actual)
May 12, 2017
Last Update Submitted That Met QC Criteria
May 10, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Pathologic Processes
- Mood Disorders
- Depression
- Depressive Disorder
- Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Enzyme Inhibitors
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Dopamine Agonists
- Dopamine Agents
- Serotonin 5-HT1 Receptor Agonists
- Serotonin Receptor Agonists
- Serotonin 5-HT2 Receptor Antagonists
- Serotonin Antagonists
- Dopamine D2 Receptor Antagonists
- Dopamine Antagonists
- Cytochrome P-450 Enzyme Inhibitors
- Antidepressive Agents, Second-Generation
- Cytochrome P-450 CYP2D6 Inhibitors
- Dopamine Uptake Inhibitors
- Aripiprazole
- Bupropion
- Risperidone
Other Study ID Numbers
- Z171100000117016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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