A Comparison of Adjunctive Quetiapine Versus Adjunctive Haloperidol in Combination with Sodium Valproate for Treatment of Patients with Bipolar I Disorder
Phase 3
Recruiting
- Conditions
- F31.13Bipolar Mood Disorder with Mania or Mixed feature.Bipolar disorder, current episode manic without psychotic features, severe Bipolar disorder , current episode mixed
- Registration Number
- IRCT20150221021168N3
- Lead Sponsor
- niversity of social welfare and rehabilitation sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Patients of 18 years or above
Patients were diagnosed with Bipolar I disorder experiencing an episode of acute mania or mixed feature according to psychiatric interview
All participants voluntarily provided a written informed consent form
Exclusion Criteria
History of Sensitivity to Sodium Valproate , Quetiapine and Haloperidol
History of Neurological , Cardiovascular , Respiratory, Blood , kidney, Hepatic , Endocrine, Immunological and other Systemic Disease
Pregnancy and Breastfeeding Period
HIV Positive and Uncontrolled Diabetic patients
Substance Use Disorders
History of Brain Blood Vessels Diseases and Head Trauma
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The relevant mania score obtained by the Young Mania Rating Scale. Timepoint: The assessment of treatment response prior the beginning of the study, as well as 3 and 6 weeks after the study onset. Method of measurement: Young Mania Rating Scale.
- Secondary Outcome Measures
Name Time Method The extent of drowsiness. Timepoint: Three and six weeks after the onset of the study. Method of measurement: The Epworth Sleepiness Scale.