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Effect and mechanisms of acupuncture at Wuzangshu and Geshu for Bipolar Depressio

Phase 1
Conditions
bipolar disorder
Registration Number
ITMCTR2200006464
Lead Sponsor
Beijing Anding Hospital, Capital Medical University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

We confirm the depressive episodes of bipolar disorder according to International Classifcation of Diseases 10th Edition (ICD-10). The participants meet the diagnostic criteria; no gender limitation, aged between 18 and 60; Hamilton-17 depression Scale score =18; no taken psychotropic drugs, or be cleaned for one week according to the provisions; voluntary participation, and informed consent signed by themselves and/or their guardians.

Exclusion Criteria

We exclude the patients according to any of the following 9 criteria in this clinical study: mental disorders caused by organic brain diseases; morbid psychoactive substance related disorder, cyclic mood disorder, rapid cycle bipolar disorder and personality disorder (ICD-10 diagnostic criteria); have aggressive behavior, or high suicidal risk; with serious physical diseases; have experienced obvious discomfort such as needle-sickness during acupuncture treatment; allergic to valproate, or stop taking valproate due to adverse reactions; pregnant or lactating women; have participated in other pharmaceutical clinical trials in the past one month; receive modified electroconvulsive treatment (MECT) in the last month.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Hamilton-17 Depression Scale;
Secondary Outcome Measures
NameTimeMethod
8-week remission rate;Young's Manic Rating Scale;Hamilton Anxiety Scale;Clinical Global Impression Scale;2-week early onset rate;8-week response rate;Switching rate;Side effect Scale;
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