Comparison of Efficacy of Quetiapine Alone versus Quetiapine plus Lamotrigine in the Treatment of Depressive episode of Bipolar I and II Disorder

university of health sciences, lahore0 个研究点目标入组 166 人开始时间: 2023年7月12日最近更新: 2024年8月19日

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•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.

发起方

university of health sciences, lahore