Guidance Model of Standardized Treatment of Antidepressants in Bipolar Disorder

Peking University

Status and phase: Unknown; Phase 4

Conditions: the Use of Antidepressants in Patients With Bipolar Depression

Treatments: Drug: lithium carbonate combined with SSRI antidepressant treatment; Drug: Lithium Carbonate

Study type: Interventional

Funder types: Other

Identifiers

NCT03148535

2016-1-4111

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• age 18-55 years old, bipolar depression

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

lithium carbonate

Experimental group

Description:

recieve lithium carbonate

Treatment:

Drug: Lithium Carbonate

lithium carbonate combined with SSRI antidepressant treatment

Experimental group

Description:

recieve lithium carbonate combined with SSRI antidepressant treatment

Treatment:

Drug: lithium carbonate combined with SSRI antidepressant treatment