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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 24, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 27, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 30, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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