Conditions: Major Depressive Disorder Generalized Anxiety Disorder
Keywords: seroquel XR quetiapine XR major depression generalized anxiety disorder CBT co-morbid MDD
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 62
Healthy volunteers: no

Brief summary:
The primary objective of the study is to determine whether quetiapine extended-release in combination with cognitive behavioral therapy (CBT) is more effective than CBT plus placebo in treating depressive and anxiety symptoms in patients with both major depression and generalized anxiety disorder. Approximately 64 individuals (adults 18-65) will be randomly assigned to treatment group for 16 weeks. Weekly CBT sessions will be conducted lasting about 45 minutes and weekly visits with the study psychiatrist lasting about 20 minutes in which medication will be discussed. Both clinician administered and self-report measures will be used to compare groups before and after 16 weeks.

Detailed description:
This study will evaluate the efficacy of quetiapine extended-release as adjunctive therapy to cognitive behavioral therapy (CBT) compared to CBT plus placebo in the treatment of patients with comorbid major depression and generalized anxiety disorder. We will also evaluate the quality of life in patients with comorbid MDD/GAD, the response and remission rates by treatment group, changes in sleep quality, and tolerability of adjunctive quetiapine to CBT.

Arms:
arm 1: quetiapine target dosage will be 150 mg/day, beginning at 50 mg/day 16 weeks of treatment including CBT arm 2: treatment group receiving placebo pill plus CBT

Interventions: intervention 1: seroquel xr intervention 2: CBT
Intervention descriptions: intervention 1: Quetiapine target dosage will be 150 mg/day, beginning at 50 mg/day intervention 2: 16 weeks of treatment

Protocol document: