Quetiapine Augmentation for Treatment-resistant PTSD
Condition: Combat Disorders; Stress Disorders, Post-Traumatic
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Combat Disorders
Intervention: Open Label (OL) Paroxetine; Placebo; Quetiapine
Intervention description: Open-label Paroxetine; Double-blind placebo taken with OL paroxetine; Double-blind quetiapine taken with OL paroxetine
Intervention MeSH terms: Quetiapine Fumarate; Paroxetine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 124.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Atypical Antipsychotics; Controlled Trial; Paroxetine; Quetiapine; Stress Disorders, Post-Traumatic; Treatment refractory; Treatment resistant

Summary:

      The purpose of this study is to compare the response of veterans with PTSD without an optimal
      response to paroxetine to quetiapine augmentation versus placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Veteran age 18 to 75.

          -  Competent to give informed consent.

          -  Meeting DSM-IV criteria for PTSD.

          -  Minimal CAPS score of 50 at baseline.

          -  If female of childbearing potential, patient must have a negative pregnancy test and,
             if sexually active, be using a medically approved contraceptive method.

          -  Patients who have not taken psychiatric medications within 1 week prior to study entry
             (except fluoxetine [5 weeks])

               -  monoamine oxidase inhibitors (MAOIs [4 weeks])

               -  depot neuroleptics [4 weeks])

               -  or any investigational drug within 30 days prior to study enrollment.

          -  To be eligible for Phase II

               -  patients must be refractory to paroxetine in Phase I, as defined by less than 30%
                  reduction in CAPS scores or a minimum CAPS score of 50 at week 8

               -  must have PTSD symptoms at least moderate severity on CGI-S

               -  and must have been compliant with study medicine in Phase I, as defined by taking
                  at least 80% of prescribed doses.

        Exclusion Criteria:

          -  History of sensitivity to paroxetine or quetiapine.

          -  Failure to respond to a prior adequate therapeutic trial i.e. minimum of 8 weeks at
             maximum tolerated dose of paroxetine (up to 60 mg daily) or quetiapine (up to 800 mg
             daily).

          -  Women who are

               -  breast-feeding

               -  pregnant

               -  expect to become pregnant during the course of the study

               -  or are sexually active and are not using a medically acceptable method of birth
                  control.

          -  Presence of clinically significant hepatic

               -  cardiovascular

               -  or other medical conditions that may prevent safe administration of paroxetine or
                  quetiapine

               -  or any other clinically significant unstable medical conditions.