Effects of ziprasidone vs. placebo during the first four weeks of eight weeks sertraline treatment in patients with posttraumatic stress disorder (PTSD)
- Conditions
- Post-traumatic Stress Disorder (PTSD) according to DSM-IV criteria
- Registration Number
- EUCTR2005-000223-42-DE
- Lead Sponsor
- niversity Hospital Hamburg-Eppendorf, Psychiatry
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
PTSD (DSM-IV), age over 18 years
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Psychotic disorders, current substance dependence
Contraindications against study medication (including hypersensitivity against tartrazine
In women: Gravidity, lactation, lack of reliable contraception
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Does additional ziprasidone medication (4 weeks) during the first 8 weeks of sertraline treatment result in a more rapid reduction of PTSD and depressive symptoms?;Secondary Objective: Do the effects in the ziprasidone group persist until week 8?;Primary end point(s): Posttraumatic Diagnostic Scale (PDS) score, Beck Depression Inventary (BDI) score
- Secondary Outcome Measures
Name Time Method