Skip to content

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200005825
Enrollment
Unknown
Registered
1990-01-01
Start date
2018-07-01
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar disorder

Interventions

medicine:Quetiapine
traditional Chinese medicine:Traditional Chinese medicine granule preparation

Sponsors

Beijing Anding Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Hamilton Depression Scale;Syndrome integral of internal depression of fire heat in traditional Chinese Medicine;

Secondary

MeasureTime frame
Clinical Global Impression;Hamilton Anxiety Scale;

Countries

China

Contacts

Public ContactDongqing Yin
yindq1123@163.com13811005469

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026