A Study of Diagnosis and Treatment of Depression Based on Biological Evidence of Dopamine Reward Pathway

NCT03148509 | Unknown Phase 4

• 1 other identifier: Z171100000117016
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diagnosis and Treatment of Depression

Outcome Measures

Primary Outcomes (1)

• Hamilton Rating Scale for Depression

  8 weeks

Study Arms (3)

bupropion

EXPERIMENTAL

receive bupropion

Drug: risperidone

risperidone

EXPERIMENTAL

receive risperidone

Drug: aripiprazole

aripiprazole

EXPERIMENTAL

receive aripiprazole

Drug: bupropion

Interventions

risperidone DRUG

DA receptor-mediated drugs

bupropion

aripiprazole DRUG

DA receptor-mediated drugs

risperidone

bupropion DRUG

DA receptor-mediated drugs

aripiprazole

Eligibility Criteria

• Age: 15 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University: lead

MeSH Terms

Conditions

Disease

Interventions

Risperidone; Aripiprazole; Bupropion

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Propiophenones; Ketones; Organic Chemicals

Central Study Contacts

Ji-Tao Li, MD

CONTACT

010-62723742; ljt_102124@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Psychopharmacology Division,Institute of Mental Health

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: May 11, 2017
• Study Start: June 1, 2017
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: May 12, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share