A clinical trial to study the effects of two drugs, olanzapine and asenapine in patients with manic episode of bipolar 1 disorder
Phase 4
Completed
- Conditions
- Health Condition 1: null- Manic Episode in Bipolar 1 disorder
- Registration Number
- CTRI/2013/09/003950
- Lead Sponsor
- nil
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
Inclusion Criteria
OPD patients
Patient free of psychotropic drugs for at least 1 month
Age > 18 or < 55 yrs
Both Sex
Legitimate consent
Those who meet DSM-IV-TR criteria for acute mania in Bipolar1 disorder (American Psychiatric Association, 2000).
Exclusion Criteria
Pregnancy, lactation
H/o epilepsy
Presence of uncontrolled, unstable, clinically significant medical condition
Narrow angle glaucoma
Primary psychiatric disorder other than bipolar
History of substance dependence
History of rapid cycling ((American Psychiatric Association, 2000)
Judged by the clinical investigator - inability to reduce intake of lorazepam to a maximum of 4 mg per day
Intolerant or allergic to the drug
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Decrease in Mean±SEM in YMRS (Young Mania Rating Scale) scale below 12Timepoint: Decrease in Mean±SEM in YMRS (Young Mania Rating Scale) scale below 12 at 3 weeks and 6 weeks
- Secondary Outcome Measures
Name Time Method 1.CGI (Clinical Global Impression) <br/ ><br>2.Rescue count. Assessment will be done at 3 weeks and 6 weeks. <br/ ><br>4.Additional dose required to prevent impending exacerbation <br/ ><br>5.N (%) of subjects presenting with impending exacerbations <br/ ><br>N (%) of subjects presenting with exacerbations <br/ ><br>Timepoint: 3 weeks and 6 weeks