Towards Neurobiology-based Diagnosis and Treatment of Affective Disorders

August 24, 2021 updated by: Si Tianmei, Peking University

Clinical Psychopharmacology Division

The project is a multi-center, prospective cohort study. The study's total targeted enrollment is 400 first-episode patients with major depressive disorder (MDD) and 400 healthy controls.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Four hundred patients with a primary diagnosis of depression and HAMD-17 scores ≥14 at baseline visit are to be assigned to one of the second-generation antidepressant drugs, including escitalopram, duloxetine, mirtazapine, paroxetine, sertraline, etc based on investigators' clinical practice. Initial treatment consists of a 8-week course with one of these monotherapies. Patients who meet criteria for full remission are followed for a 22-month follow-up phase to monitor for depression recurrence. Patients who do not remit are offered another 8 weeks of acute treatment, including combination therapy or switching to other antidepressant based on investigators' clinical practice. The clinical assessment (Hamilton Depression Rating Scale(HAMD)/ Clinical general impression (CGI) /the Positive and Negative Affect Schedule (PANAS) /subtypes of depression, Dimensional Anhedonia Rating Scale (DARS) , etc), early life stress, neuropsychological test, and biological examination (MRI, genetics, neurochemistry, and immunology) were conducted to identify the biomarkers associated with diagnosis, treatment efficacy prediction of depression. Among the 400 patients, about 100 patients receive MRI scans at baseline and after treatment.

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

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

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Recruiting
        • Institute of Mental Health, Peking University
        • Contact:
        • Principal Investigator:
          • Tianmei Si, PhD.

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

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with major depressive disorder

Description

Inclusion Criteria:

1. Patients with depression

  • The inclusion criteria for depressed patients were: male or female outpatients aged between 18 and 55 years old
  • Currently in acute depressive episode
  • Total HAMD-17 score≥14 at baseline visit.
  • The diagnosis of depression was confirmed by a trained psychiatrists using the Mini-International Neuropsychiatric Interview (MINI).
  • The patients participating in imaging scans should additionally satisfy: not taking psychiatric drugs within last two weeks (except for benzodiazepine) or fluoxetine last one month
  • Not receiving ECT within last 6 months.

Exclusion Criteria:

  • Unable to complete the questionnaire and psychological assessment independently
  • Significant cognitive impairments determined by system mental examination and inability to sign an informed consent form
  • Past or presently suffering from other psychiatric disorders, alcohol and drug dependence
  • Suffering from major physical diseases, such as cardiovascular and cerebrovascular diseases, respiratory diseases, kidney disease, cancer and so on; personality disorder
  • Intellectual disabilities
  • Suicidal behavior
  • Being participating in other studies.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Escitalopram-for MDD
Eligible patients were assigned to escitalopram treatment based on investigators' clinical practice.
Drug: Escitalopram Pill
escitalopram 10~20mg/day
Other Names:
  • Lexapro
Duloxetine-for MDD
Eligible patients were assigned to duloxetine treatment based on investigators' clinical practice.
Drug: Duloxetine
duloxetine 30~120mg/day
Other Names:
  • Cymbalta
Mirtazepine-for MDD
Eligible patients were assigned to mirtazepine treatment based on investigators' clinical practice.
Drug: Mirtazapine Pill
Mirtazapine 15~45mg/day
Other Names:
  • Remeron
other antidepressant-for MDD
Eligible patients were assigned to other antidepressant treatment (including sertraline, paroxetine, fluoxetine, venlafaxine, etc) based on investigators' clinical practice.
Drug: Other Antidepressants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
reduction in HAMD total scores
Time Frame: 8 weeks
reduction more than 50% was regarded as response
8 weeks
remision
Time Frame: 8 weeks
HAMD total score less than 7
8 weeks

Collaborators and Investigators

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

Sponsor

Peking University

Investigators

  • Principal Investigator: Tianmei Si, PhD, Sixth hospital of beijing 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)

January 1, 2016

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

August 1, 2022

Study Registration Dates

First Submitted

May 24, 2016

First Submitted That Met QC Criteria

September 22, 2017

First Posted (Actual)

September 27, 2017

Study Record Updates

Last Update Posted (Actual)

August 30, 2021

Last Update Submitted That Met QC Criteria

August 24, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001 (Buy Pharma Ecza Deposu San. Tic. Ltd.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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.

Clinical Trials on Affective Disorder

Clinical Trials on Escitalopram Pill

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe