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Effects of ziprasidone vs. placebo during the first four weeks of eight weeks sertraline treatment in patients with posttraumatic stress disorder (PTSD)

Effects of ziprasidone vs. placebo during the first four weeks of eight weeks sertraline treatment in patients with posttraumatic stress disorder (PTSD)

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-000223-42-DE
Enrollment
24
Registered
2005-11-03
Start date
2005-10-31
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

Post-traumatic Stress Disorder (PTSD) according to DSM-IV criteria

Interventions

Trade Name: Zoloft 50 mg Product Name: Zoloft 50 mg Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Sertralin Concentration unit: mg milligram(s) Concentration type: equal Concentration n

Sponsors

University Hospital Hamburg-Eppendorf, Psychiatry
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: Psychotic disorders, current substance dependence Contraindications against study medication (including hypersensitivity against tartrazine In women: Gravidity, lactation, lack of reliable contraception

Design outcomes

Primary

MeasureTime frame
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

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026