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Guidance Model of Standardized Treatment of Antidepressants in Bipolar Disorder

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ClinicalTrials.gov Identifier: NCT03148535
Recruitment Status : Unknown
Verified May 2017 by Si Tianmei, Peking University.
Recruitment status was:  Recruiting
First Posted : May 11, 2017
Last Update Posted : May 11, 2017
Sponsor:
Information provided by (Responsible Party):
Si Tianmei, Peking University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
the Use of Antidepressants in Patients With Bipolar Depression Drug: Lithium Carbonate Drug: lithium carbonate combined with SSRI antidepressant treatment Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Psychopharmacology Division Institute of Mental Health, Peking University
Estimated Study Start Date : June 1, 2017
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants

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




Primary Outcome Measures :
  1. HRSD reduction ratio [ Time Frame: 8 weeks ]
    HRSD reduction ratio



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age 18-55 years old, bipolar depression

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03148535


Contacts
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Contact: Ji-Tao Li, MD 010-62723742 ljt_102124@163.com

Locations
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China, Beijing
Institute of mental health, Peking University Recruiting
Beijing, Beijing, China, 100191
Contact: Tianmei Si, PhD.    8610-82801960    si.tian-mei@163.com   
Principal Investigator: Tianmei Si, PhD.         
China, Hebei
The first hospital of Hebei Province University Recruiting
Shijiazhuang, Hebei, China, 050000
Contact: Xueyi Wang, Professor    0311-85917290      
Sub-Investigator: Xueyi Wang         
China, Jiangsu
Nanjing Brain Hospital Recruiting
Nanjing, Jiangsu, China, 210000
Contact: Zhijian Yao, PhD.    86-13851580276    zhijianyao@163.com   
China, Liaoning
Dalian No.7 People's Hospital Recruiting
Dalian, Liaoning, China, 116000
Contact: Shoufu Xie, MD.    86-18441168381    shoufuxie@126.com   
Sponsors and Collaborators
Peking University

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Responsible Party: Si Tianmei, Clinical Psychopharmacology Division Institute of Mental Health, Peking University
ClinicalTrials.gov Identifier: NCT03148535     History of Changes
Other Study ID Numbers: 2016-1-4111
First Posted: May 11, 2017    Key Record Dates
Last Update Posted: May 11, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Lithium Carbonate
Antidepressive Agents
Psychotropic Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs