Guidance Model of Standardized Treatment of Antidepressants in Bipolar Disorder

NCT ID: NCT03148535

Last Updated: 2017-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2018-12-01

Brief Summary

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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

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Conditions

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the Use of Antidepressants in Patients With Bipolar Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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lithium carbonate

recieve lithium carbonate

Group Type EXPERIMENTAL

Lithium Carbonate

Intervention Type DRUG

bipolar depression recieve lithium Carbonate treatment

lithium carbonate combined with SSRI antidepressant treatment

recieve lithium carbonate combined with SSRI antidepressant treatment

Group Type EXPERIMENTAL

lithium carbonate combined with SSRI antidepressant treatment

Intervention Type DRUG

lithium carbonate combined with SSRI antidepressant treatment

Interventions

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Lithium Carbonate

bipolar depression recieve lithium Carbonate treatment

Intervention Type DRUG

lithium carbonate combined with SSRI antidepressant treatment

lithium carbonate combined with SSRI antidepressant treatment

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* age 18-55 years old, bipolar depression

Exclusion Criteria

* other mental illness, serious somatic illnesses, MRI contradictions.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Peking University

OTHER

Sponsor Role lead

Responsible Party

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Si Tianmei

Clinical Psychopharmacology Division Institute of Mental Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Institute of mental health, Peking University

Beijing, Beijing Municipality, China

Site Status RECRUITING

The first hospital of Hebei Province University

Shijiazhuang, Hebei, China

Site Status RECRUITING

Nanjing Brain Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

Dalian No.7 People's Hospital

Dalian, Liaoning, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ji-Tao Li, MD

Role: CONTACT

010-62723742

Facility Contacts

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Tianmei Si, PhD.

Role: primary

8610-82801960

Xueyi Wang, Professor

Role: primary

0311-85917290

Zhijian Yao, PhD.

Role: primary

86-13851580276

Shoufu Xie, MD.

Role: primary

86-18441168381

Other Identifiers

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2016-1-4111

Identifier Type: -

Identifier Source: org_study_id

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