Guidance Model of Standardized Treatment of Antidepressants in Bipolar Disorder

May 9, 2017 updated by: Si Tianmei, Peking University

Clinical Psychopharmacology Division Institute of Mental Health, Peking University

The bipolar depression patients of 18-55 years old were recruited. At the time of enrollment, the demographic, symptomatic, neuropsychological, neurobiological and genetic data was collected. After the completion of the baseline assessment and examination, the patients were given lithium carbonate or lithium carbonate combined with SSRI antidepressant treatment. Clinical evaluation was performed at 2 and 8 weeks after treatment, including the therapeutic efficacy and adverse drug reactions, and monitoring of serum lithium concentration. The patients further receive the fMRI scans after treatment for 8 weeks. Through above work, this study aimed to provide some guidance for the use of antidepressants in patients with bipolar depression.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

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
        • Institute of Mental Health, Peking University
        • Contact:
        • Principal Investigator:
          • Tianmei Si, PhD.
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • Recruiting
        • The first hospital of Hebei Province University
        • Contact:
          • Xueyi Wang, Professor
          • Phone Number: 0311-85917290
        • Sub-Investigator:
          • Xueyi Wang
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • Nanjing Brain Hospital
        • Contact:
    • Liaoning
      • Dalian, Liaoning, China, 116000
        • Recruiting
        • Dalian No.7 People's Hospital
        • Contact:

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

Description

Inclusion Criteria:

  • age 18-55 years old, bipolar depression

Exclusion Criteria:

  • other mental illness, serious somatic illnesses, MRI contradictions.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: lithium carbonate
recieve lithium carbonate
Drug: Lithium Carbonate
bipolar depression recieve lithium Carbonate treatment
Experimental: lithium carbonate combined with SSRI antidepressant treatment
recieve lithium carbonate combined with SSRI antidepressant treatment
Drug: lithium carbonate combined with SSRI antidepressant treatment
lithium carbonate combined with SSRI antidepressant treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HRSD reduction ratio
Time Frame: 8 weeks
HRSD reduction ratio
8 weeks

Collaborators and Investigators

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

Sponsor

Peking University

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 (Anticipated)

June 1, 2017

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

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)

May 11, 2017

Last Update Submitted That Met QC Criteria

May 9, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-1-4111

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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