Panic Disorder Clinical Trial
Official title:
An 8-week, Randomized, Double-Blind, Placebo-Controlled Trial of Seroquel SR Co-administration for SSRI-Resistant, Comorbid Panic Disorder
The primary objective of this study is to test the hypothesis that a SSRI plus quetiapine SR (Seroquel SR) will result in superior early (first 1-3 weeks of treatment) stabilization of panic symptoms in SSRI-resistant, comorbid Panic Disorder patients versus a SSRI plus placebo.
This was a single-site, double-blind, placebo-controlled (PLAC), randomized, parallel group
(2 groups), 8-week, quetiapine extended release (XR) coadministration trial. SSRI resistance
was determined either historically or prospectively. Patients were randomized if they
remained moderately ill (CGI-S score ≥ 4). Change in the PDSS scale total score was the
primary efficacy outcome measure. Responders were identified as those with a ≥50 % decrease
from their baseline PDSS score. In the early weeks of therapy, XR was flexibly and gradually
titrated from 50 to 400 mg/day.
Conclusions: This proof-of-concept RCT did not support the efficacy of this treatment
strategy for SSRI-resistant PD. Quetiapine XR was generally well-tolerated. Important
limitations were the small sample size, and the relatively low average dose of quetiapine XR
used.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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