A Neuroimaging and Epigenetic Investigation of Antidepressants in Depression

September 14, 2019 updated by: Yuqi Cheng, Kunming Medical University

The purpose of this study is:

  1. to find out the structural or functional effects of selective serotonin reuptake inhibitors (SSRI) in major depressive disorder (MDD);
  2. find special abnormalities in depression secondary to other disease, e.g., autoimmune disease like systemic lupus erythematosus (SLE).
  3. find the relationship between the efficacy of antidepressant and the change of neuroimaging in MDD
  4. to find possible predispose to MDD
  5. to explore the DNA methylation status in depression;

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. to explore the pathology of depression
  2. to identify the difference between MDD and depression secondary to other disease ,especially autoimmune disease
  3. to explore the effect of gene-environment interaction on the epigenetic regulation of the depression

Study Type

Interventional

Enrollment (Actual)

200

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
    • Yunnan
      • Kunming, Yunnan, China, 650031
        • The First Affiliated Hospital of Kunming Medical College

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • DSM-IV Major Depression or Dysthymia
  • Age 18-65
  • Physically healthy
  • Drug-free

Exclusion Criteria:

  • Body metal (e.g., wire stitches, screws in bones, stainless steel hips)
  • History of Psychosis or Epilepsy
  • Current (past six months) Substance Use Disorder (illicit drugs and/or alcohol)
  • Bipolar I
  • Need for wash-out from effective treatment in order to participate
  • Pregnant
  • High suicide risk
  • Currently taking (within 2 weeks; 4 weeks for Fluoxetine) antidepressants

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: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A,1
A: Escitalopram, 20 mg/day,8weeks
Drug: Escitalopram
A,1: Escitalopram, oral, 20 mg/day, 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change of fMRI after medication
Time Frame: baseline, 4 weeks, 8 weeks
baseline, 4 weeks, 8 weeks

Collaborators and Investigators

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

Sponsor

Kunming Medical University

Collaborators

Chinese Academy of Sciences

Investigators

  • Study Director: Xu Xiufeng, Kunming Medical 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

June 1, 2008

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

June 20, 2008

First Submitted That Met QC Criteria

June 20, 2008

First Posted (Estimate)

June 23, 2008

Study Record Updates

Last Update Posted (Actual)

September 17, 2019

Last Update Submitted That Met QC Criteria

September 14, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Kunming MC

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.

Clinical Trials on Depression

Clinical Trials on Escitalopram

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Panama

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe