Health Condition 1: null- Manic Episode in Bipolar 1 disorder
Conditions
Interventions
Intervention1: tab olanzapine: tab olanzapine 5-10 mg and tab Divaloprex 20 mg/kg/ day for 6 weeks
Control Intervention1: tab asenapine: tab asenapine 5-10 mg and tab Divaloprex 20 mg/kg/ day for 6 we
Sponsors
nil
Eligibility
Inclusion criteria
Inclusion criteria: OPD patients Patient free of psychotropic drugs for at least 1 month Age > 18 or Both Sex Legitimate consent Those who meet DSM-IV-TR criteria for acute mania in Bipolar1 disorder (American Psychiatric Association, 2000).
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1. CGI (Clinical Global Impression) 2. Rescue count. Assessment will be done at 3 weeks and 6 weeks. 4. Additional dose required to prevent impending exacerbation 5. N (%) of subjects presenting with impending exacerbations N (%) of subjects presenting with exacerbations Timepoint: 3 weeks and 6 weeks | — |
Countries
India
Contacts
Public ContactVivek Mahajan
Government Medical College Jammu
Outcome results
None listed