Bipolar depression Bipolar depression
Conditions
Interventions
Quetiapine,Quetiapine plus Lamotrigine
Active Comparator Drug,Active Comparator Drug
Sponsors
university of health sciences, lahore
Eligibility
Sex/Gender
All
Age
16 Years to 45 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Depressive Symptomatology - Self-Report 16 will be measured after 4 weeks, 8 weeks, and 12 weeks of initiation of treatment questionnaire/ scoring system | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse effects will be measured after 4 weeks, 8 weeks, and 12 weeks of initiation of treatment Binary method (YES/NO) | — |
Countries
Pakistan
Contacts
Public ContactHuma Kanwal
Postgraduate medical institute lahore
Outcome results
None listed