The purpose of the study is to determine if quetiapine is effective in the treatment of PTSD.
Objective: To assess the impact of quetiapine on core PTSD symptoms and associated psychiatric comorbidity including depressive and positive and negative psychotic symptoms. Research Design: 12-week, double-blind, placebo-controlled, randomized, fixed-flexible dose trial of quetiapine monotherapy. Intervention: Eligible patients will be randomized to receive quetiapine starting at 25 mg daily or matching placebo. Dose adjustments (to a minimum of 50 mg or a maximum of 800 mg), will be made at the investigator's discretion and according to patient's clinical response.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
Dosage initiated at 25 mg HS with gradual titration to target dose of 400 mg HS, up to maximum of 800 mg HS.
Dosage initiated at 25 mg HS with gradual titration to target dose of 400 mg HS, up to maximum of 800 mg HS.
NM VA Healthcare System
Albuquerque, New Mexico, United States
Ralph H. Johnson VAMC
Charleston, South Carolina, United States
Global scores on Clinician Administered PTSD Scale - One Week Symptom Version (CAPS-SX) at week 12
Week 12 scores on Positive and Negative Syndrome Scale (PANSS)
Hamilton Depression Rating Scale (HAMD)
Hamilton Rating Scale of Anxiety (HAMA)
Clinical Global Impression Severity Scale (CGI-S)
Clinical Global Impression Improvement Scale (CGI-I)
Davidson Trauma Scale (DTS)
Pittsburgh Sleep Quality Inventory/Pittsburgh Sleep Quality Inventory Addendum (PSQI/PSQI-A)
Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)
SDS
Arizona Sexual Experience Scale (ASEX)
AIMS
BAS
SAS
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