60
Participants
Start Date
February 29, 2008
Primary Completion Date
July 31, 2010
Study Completion Date
July 31, 2010
quetiapine fumarate
At baseline, subjects in the experimental group will initially be administered 50 mg/day of Seroquel XR™ (extended release formulation of quetiapine fumarate), to be titrated up to 400 mg/day of Seroquel XR™ by the end of the second week. By the end of week 2, subjects will be stabilized on a dose of 400 mg/day or alternatively 300, 200, 100, or 50 mg/day of study drug, as tolerated. If a subject is unable to tolerate the 50 mg/day dose, he or she will be discontinued from the drug portion of the study.
Matched Placebo
Subjects randomized to the placebo comparator group will follow the same titration and dosing procedures as the experimental group, but will receive matched placebo tablets.
Cognitive-behavioral Therapy
During the 12 week treatment phase, all subjects attended weekly group cognitive-behavioral therapy sessions. This therapy platform utilized the cognitive-behavioral therapy manual, Seeking Safety. Seeking Safety has been shown to effectively reduce substance use and to improve psychological functioning in a variety of populations.
VA Puget Sound Health Care System, Tacoma
Collaborators (1)
VA Puget Sound Health Care System
FED
AstraZeneca
INDUSTRY
Seattle Institute for Biomedical and Clinical Research
OTHER