Brain imaging in Posttraumatic Stress Disorder (PTSD): effects of paroxetine and Trauma-Focused Cognitive Behavioural Therapy (TF-CBT)

Conditions: PTSD en stress disorder

Registration Number: NL-OMON33322

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 88

Inclusion Criteria

CAPS score of * 50 (only for PTSD patients)
Male and female, aged 18 years and above
Written informed consent
Eligible for exposure therapy
Eligible for fMRI (no metals, pacemaker or claustrophobia)

Exclusion Criteria

Suicidal risk
Presence of any of the following DSM IV diagnoses, at present or in the past: psychotic disorder incl. schizophrenia, a bipolar disorder, depression with psychotic features, a panic disorder with or without agoraphobia or excessive substance related disorder over the past 6 months
Primary diagnosis of severe depressive disorder
Presence of primary or co-morbid personality disorder
An organic disorder
Taking any psychotropic medications at present

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameter included is the difference in structural and functional<br /><br>imaging results in patients with PTSD versus controls. Secondly, effective<br /><br>versus non-effective therapy (TF-CBT and paroxetine) will be compared with<br /><br>regard to structural and functional differences. Furthermore, neuro-immune,<br /><br>neuro-endocrine and neurocognitive data will be associated with structural and<br /><br>functional differences in patients and controls. Functional differences in the<br /><br>small subgroup of PTSD-patients receiving biofeedback as an adjunct to TF-CBT<br /><br>will be compared to PTSD-patients receiving regular TF-CBT as part of the main<br /><br>treatment study.</p><br>

Secondary Outcome Measures