A randomized, double-blind and controlled study of clearing heat and resolving depression in the treatment of bipolar depression and fire heat depressio

Not Applicable

Completed

• Conditions: Bipolar disorder

• Registration Number: ITMCTR2200005825
• Lead Sponsor: Beijing Anding Hospital, Capital Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

? The diagnosis of bipolar disorder was evaluated by structured clinical interview for DSM-IV Axis I disorders (SCID-I / P). Bipolar disorder was diagnosed according to DSM-IV diagnostic criteria and is currently a depressive episode; ? Age 18-40 years; ? 24 items Hamilton Depression Scale (hamd-24) = 20 points, = 35 points (lasting for 2 weeks), and Hamilton Anxiety Scale (HAMA) = 7 points (lasting for more than 2 weeks); Young manic Rating Scale (YMRS) = 5 points; ? Meet the diagnostic criteria of fire heat syndrome; ? Junior high school education or above; ? No somatic diseases and endocrine diseases; ? Have sufficient audio-visual level to complete the examination necessary for the study; ? The patient and his guardian agreed and signed the informed consent form.

Exclusion Criteria

? The possibility of bipolar depression caused by somatic diseases and endocrine diseases; ? The possibility of bipolar depression caused by psychoactive substances; ? Accompanied by other mental diseases, such as anxiety, schizophrenia, manic episode, obsessive-compulsive disorder, etc; ? Patients with unstable vital signs and serious suicidal concept; ? Women breastfeeding, pregnant or preparing for pregnancy; ? Alcohol and drug dependence within 1 year; ? Those with a history of severe drug allergy; ? Those who have participated in clinical trials of other drugs within 30 days; ? Patients who had taken monoamine oxidase inhibitors within 4 weeks before enrollment, or patients treated with long-acting mental blockers, or patients receiving hormone drugs

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hamilton Depression Scale;Syndrome integral of internal depression of fire heat in traditional Chinese Medicine;

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impression;Hamilton Anxiety Scale;