Guidance Model of Standardized Treatment of Antidepressants in Bipolar Disorder

Phase 4

• Conditions: the Use of Antidepressants in Patients With Bipolar Depression
• Interventions: Drug: lithium carbonate combined with SSRI antidepressant treatment; Drug: Lithium Carbonate

• Registration Number: NCT03148535
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-05
• Study First Submitted: 2017-05-09
• Study First Submitted QC: 2017-05-09
• Last Update Submitted: 2017-05-09
• Study First Posted: 2017-05-11
• Last Update Posted: 2017-05-11
• Study Start: 2017-06-01
• Primary Completion: 2018-12-01
• Study Completion: 2018-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• age 18-55 years old, bipolar depression

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lithium carbonate combined with SSRI antidepressant treatment	lithium carbonate combined with SSRI antidepressant treatment	recieve lithium carbonate combined with SSRI antidepressant treatment
lithium carbonate	Lithium Carbonate	recieve lithium carbonate

Primary Outcome Measures

Name	Time	Method
HRSD reduction ratio	8 weeks	HRSD reduction ratio

Trial Locations

Locations (4)

The first hospital of Hebei Province University; 🇨🇳 Shijiazhuang, Hebei, China

Dalian No.7 People's Hospital; 🇨🇳 Dalian, Liaoning, China

Institute of mental health, Peking University; 🇨🇳 Beijing, Beijing, China

Nanjing Brain Hospital; 🇨🇳 Nanjing, Jiangsu, China