A Diagnosis and Treatment Optimization Study of Depression Based on the Neurological Mechanism of Reward System

December 11, 2019 updated by: Si Tianmei, Peking University

Clinical Psychopharmacology Division,Institute of Mental Health,Peking University

Major depressive disorder (MDD) is a high-disabling disease. But its etiology and pathogenesis is not clear, and early recognition, diagnosis and treatment still has many challenges. Among numerous clinical manifestations of MDD, anhedonia is an important core symptom of MDD, especially in patients with melancholic features. Our previous studies and studies abroad have shown that MDD patients had functional abnormality in reward circuit. The abnormalities of reward-related core areas, such as the prefrontal cortex - nucleus accumbens - ventral tegmental area were closely associated with the development of MDD, and is an important neural basis of anhedonia. This study would take the reward circuit as mainline to carry out the etiology, diagnosis and therapeutic intervention studies of MDD. We would collect MDD patients with melancholic features and other populations with reward dysfunction. The neuroimaging techniques, stress assessment, genetic testing and drug intervention methods would be mainly used in this study. The functional connectivity of reward regions, such as the ventral striatum, nucleus accumben, and ventral medial prefrontal cortex, would be analyzed to identify the dysfunction of reward circuit of MDD, and its implication for early recognition, diagnosis and prediction of treatment efficacy of antidepressants. We would also investigate the effect of genetic and environmental factors on reward function of MDD and its biological basis. Finally, through modulating the reward circuit activity using animal experiments, we would verify and investigate reward dysfunction of MDD and its biological mechanisms. The project is expected to provide for new evidence for the establishment of reward mechanism - based objective diagnosis and treatment optimization strategy of MDD.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Recruiting
        • Yun-Ai SU
        • Contact:
          • Yun-Ai Su, MD

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

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • first-episode, drug naive melancholic depression; remitted depression; schizophrenia patients; first-degree relatives of depressed patients.

Exclusion Criteria:

  • major somatic diseases; DSM-IV axis I other mental illness; personality disorder, mental retardation; drug and / or alcohol dependence; serious suicidal tendencies or suicidal behavior; pregnant or lactating women; MRI 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: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: escitalopram
Eligible patients were assigned to escitalopram treatment based on investigators' clinical practice.
Drug: Escitalopram
receive escitalopram
EXPERIMENTAL: duloxetine
Eligible patients were assigned to duloxetine treatment based on investigators' clinical practice.
Drug: Duloxetine
receive duloxetine
EXPERIMENTAL: mirtazapine
Eligible patients were assigned to mirtazapine treatment based on investigators' clinical practice.
Drug: Mirtazapine
receive mirtazapine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hamilton Rating Scale for Depression
Time Frame: 8 weeks
remission defined by Hamilton Rating Scale for Depression < 7
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ACTUAL)

June 1, 2017

Primary Completion (ANTICIPATED)

December 30, 2021

Study Completion (ANTICIPATED)

June 30, 2022

Study Registration Dates

First Submitted

May 9, 2017

First Submitted That Met QC Criteria

May 9, 2017

First Posted (ACTUAL)

May 11, 2017

Study Record Updates

Last Update Posted (ACTUAL)

December 13, 2019

Last Update Submitted That Met QC Criteria

December 11, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 81630031

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

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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