Comparison of Efficacy of Quetiapine Alone versus Quetiapine plus Lamotrigine in the Treatment of Depressive episode of Bipolar I and II Disorder
- Conditions
- Bipolar depression
- Registration Number
- TCTR20230712005
- Lead Sponsor
- university of health sciences, lahore
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 166
Male or female patient age 16 to 45 years.
Patient of bipolar I or II disorder.
The patients experiencing an episode of depression at the time of enrollment with a total score on the QIDS-SR16 score of more than or equal to 11.
Patients who are rapid cyclers with more than four manic/hypomanic or depressive episodes within 12 months of the baseline evaluation.
Patients with a score greater than 12 on the Young Mania Rating Scale (YMRS).
Women who are pregnant, planning to conceive, or breastfeeding. All other women of child-bearing potential are eligible only if they have a negative pregnancy test at screening and agree to use an effective contraceptive method.
Patients who have a history of serious adverse reaction to the research medication.
Patients with prior exposure to Quetiapine or Lamotrigine within the last 2 months.
Patients with acute active suicidal ideation, recent suicide attempts, diagnosis of autism, mental retardation, or concurrent seizure disorders.
Patients with a history of substance abuse or dependency within the last 2 months.
Patients who have taken fluoxetine within 2 weeks of randomization, due to the long half-life of this medication.
Patients who have taken valproate, carbamazepine, or phenytoin within 3 days of randomization, to avoid potential drug interactions.
Patients with co-morbid medical conditions such as diabetes, renal, hepatic, or cardiac problems.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method