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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON33037
Enrollment
234
Registered
2010-03-08
Start date
2009-06-01
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PTSD en stress disorder

Interventions

Patients participating in this study, will be randomly allocated to one of two interventions: either paroxetine or TF-CBT. Paroxetine treatment will have a duration of 24 weeks. The dosage will sta

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)