The effect of spironolactone as adjunctive therapy on the improvement of cognitive symptoms and mania
Phase 3
Recruiting
- Conditions
- Bipolar disorder.Bipolar disorder
- Registration Number
- IRCT20190316043072N2
- Lead Sponsor
- Karaj University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Having DSM-V diagnostic criteria for patients with bipolar disorder with mania phase
Age 18 to 50 years
Their minimum score is 14 based on Young Mania Rating Scale (YMRS)
Exclusion Criteria
Neurological disease
Cardiovascular and hepatic disease
IQ less than 70
Drug abuse (except nicotine and caffeine)
pregnancy
Taking drugs that interfere with spironolactone .
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mood symptoms. Timepoint: Before and after the intervention. Method of measurement: Young Mania Rating Scale (YMRS), Mini-Mental State Examination (MMSE).;Sleep quality improvement. Timepoint: Before and after the intervention. Method of measurement: Pittsburgh Sleep Quality Index (PSQI).
- Secondary Outcome Measures
Name Time Method Appetite quality improvement. Timepoint: Before and after the intervention. Method of measurement: Simple appetite questionnaire.