Generalized Anxiety Disorder Clinical Trial
Official title:
A Prospective, Sixteen-Week, Double-Blind, Placebo-Controlled, Trial of Seroquel in Combination With Treatment as Usual in Patients With GAD and Remitted Comorbid Opiate Dependence
This is a 16 week study of the efficacy of quetiapine in treating symptoms of generalized
anxiety disorder (GAD) in subjects with comorbid opiate dependence. The study will be
conducted in a prospective, randomized, double-blind, and placebo-controlled fashion. Study
subjects will be inpatients at a residential drug-treatment facility, enrolled in a 1 year
methadone-to-abstinence treatment plan. Subjects will be randomized to receive either
quetiapine or placebo in addition to ongoing drug addiction treatment. Subjects will be
followed for 16 weeks and a variety of psychometric assessments will be made.
Hypothesis One: Compared to placebo, Quetiapine will demonstrate a greater reduction in
symptoms of anxiety in subjects with GAD and remitted comorbid opiate abuse.
Exploratory Hypotheses: Compared to placebo, Quetiapine will demonstrate a greater
improvement in psychosocial functioning and compliance with community norms in subjects
enrolled in a residential drug addiction treatment facility.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
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