NCT01847469.
Study name | Zonisamide in Addition to E‐CPT‐C for Veterans With PTSD and Comorbid Alcohol Dependence |
Methods | Double‐blind, placebo‐controlled randomized assignment to 6 weeks' titration and 6 weeks' maintenance of treatment with zonisamide. Participants will receive E‐CPT‐C therapy for the 12 weeks of treatment. Randomization will be done using 3: 1 ratio and will be performed by the research pharmacy using a random assignment in blocks of 4, with 3 assigned to active medication and 1 to placebo |
Participants | 50 veterans with PTSD, aged 18‐65 (inclusive), with DSM‐IV diagnosis of current PTSD and alcohol use disorders |
Interventions | Zonisamide (400 mg) or placebo |
Outcomes | Primary outcomes: CAPS; TLFB assessment |
Starting date | June 2013 |
Contact information | Elizabeth Ralevski, Ph.D. (+1)203‐932‐5711 ext. 4282, elizabeth.ralevski@yale.edu; Diana Limoncelli, B.A. (+1)203‐932‐5711 ext. 5217, diana.limoncelli@yale.edu |
Notes |
CAPS: Clinician Administered PTSD Scale; DSM: Diagnostic and Statistical Manual; PTSD: post‐traumatic stress disorder; TLFB: Timeline Followback.