The effectiveness of Paroxetine vs Trauma Focused Cognitive Behavioural Therapy (TF-CBT) in the treatment of Posttraumatic Stress Disorder (PTSD).

Phase 4

Conditions: PTSD en stress disorder

Registration Number: NL-OMON33037

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 234

Inclusion Criteria

CAPS score of * 50
Male and female, aged 18 years and above
Written informed consent
Eligible for exposure therapy

Exclusion Criteria

Suicidal risk
Presence of a psychotic disorder, a bipolar disorder, depression with psychotic features, or excessive substance related disorder over the past 6 months.
Primary diagnosis of severe depressive disorder
An organic disorder
Intolerance to paroxetine or any other SSRI, taking psychotropic medications
Pregnancy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The change in PTSD symptoms before and after treatment (at week 1, 3, 6 months,<br /><br>12 and 18 months after treatment), measured by the CAPS and determination of<br /><br>the cost-effectiveness. The primary cost-effectiveness analysis will be one<br /><br>that evaluates costs associated with an improved PTSD outcome in terms of CAPS<br /><br>scores.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>At 1 week, and 3, 6, 12 and 18 months post-intervention the following secondary<br /><br>outcomes will be assessed as well: response rate (criteria for response are a<br /><br>30% or more change compared to baseline on CAPS and a CGI score from 1 or two<br /><br>(much improved or very much improved), possible other psychopathology,<br /><br>quality of life, anxiety and depression and costs, as well as neuroendocrine<br /><br>and neuro-immune measures, neurocognitive functioning and genetic measures. </p><br>