Health Condition 1: F313- Bipolar disorder, current episodedepressed, mild or moderate severity
Conditions
Interventions
Intervention1: Cariprazine: Group A: Participants would receive Cariprazine Monotherapy of 1.5 mg/day orally for 30 days and the dose will be increased to 3mg/day from 31st day onwards
Control Interve
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: 18-65 years of age, of either sex, with a principal diagnosis of Bipolar Depression based on ICD-10 & BDRS Screening, after receiving a written informed consent A physical examination, clinical laboratory and ECG with no significant clinical results
Exclusion criteria
Exclusion criteria: 1. History or current diagnosis of various axis I disorders other than Bipolar I disorder, suicide risk as observed using MADRS scale, risk of injury to self or others, organic disorders or mental retardation 2. Patients of Unipolar depression 3. Patients with 4 or more mood episodes in the prior 12 months or any current psychiatric diagnoses, including personality disorders of significant severity to interfere with the study besides Bipolar I depression 4.History of allergic or autoimmune disorders 5.Any major cardiovascular, renal or hepatic comorbidities/diseases 6. Psychotropic drug use except eszopiclone, zolpidem, zopiclone,Chloral hydrate or zaleplon, lorazepam or diphenhydramine, benztropine or propranolol 7. Women of childbearing potential having positive UPT 8. Patients not willing to give consent for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To Compare the effectiveness of Cariprazine and Lamotrigine in Bipolar Depression using Clinical Global Impression - Improvement (CGI-I) scale.Timepoint: Baseline,2 weeks,4 weeks,8 weeks,12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the prevalence of substance abuse in the patients of bipolar depression with the help of a detailed interview.Timepoint: Baseline;To study the comparative effect of Cariprazine & Lamotrigine on substance abuse in patients of Bipolar Depression using Severity of Dependence (SDS) scale.Timepoint: Baseline,4 weeks & 12 weeks | — |
Countries
India
Contacts
Public ContactDr Sankasha Sharma
Government Medical College, Amritsar
Outcome results
None listed