Comparative treatment options in maniac depressive disorder: Cariprazine Vs Lamotrigine

Phase 4

Conditions: Health Condition 1: F313- Bipolar disorder, current episodedepressed, mild or moderate severity

Registration Number: CTRI/2024/03/064593

Lead Sponsor: A

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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