Guidance Model of Standardized Treatment of Antidepressants in Bipolar Disorder

the Use of Antidepressants in Patients With Bipolar Depression Clinical Trial

Official title:

Clinical Psychopharmacology Division Institute of Mental Health, Peking University

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03148535
• Other study ID #: 2016-1-4111
• Status: Recruiting
• Phase: Phase 4
• First received: May 9, 2017
• Last updated: May 9, 2017
• Start date: June 1, 2017
• Est. completion date: December 1, 2018

Study information

• Verified date: May 2017
• Source: Peking University
• Contact: Ji-Tao Li, MD
• Phone: 010-62723742
• Email: ljt_102124[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• age 18-55 years old, bipolar depression

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Bipolar Disorder
• the Use of Antidepressants in Patients With Bipolar Depression

Intervention

Drug:
• Lithium Carbonate
bipolar depression recieve lithium Carbonate treatment
• lithium carbonate combined with SSRI antidepressant treatment
lithium carbonate combined with SSRI antidepressant treatment

Locations

Country	Name	City	State
China	Institute of mental health, Peking University	Beijing	Beijing
China	Dalian No.7 People's Hospital	Dalian	Liaoning
China	Nanjing Brain Hospital	Nanjing	Jiangsu
China	The first hospital of Hebei Province University	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HRSD reduction ratio	HRSD reduction ratio	8 weeks