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Risperidone for PTSD in Women Survivors of Domestic Abuse and Rape
NCT00208182Phase 4
Key facts
- Status
- Completed
- Start
- Jul 2001
- Countries
- 1
- Sponsor
- Creighton University
- Modality
- Small Molecules
- Drugs
- risperidone
- Conditions
- post-traumatic stress disorder (PTSD)
01
Overview
Phase 4, randomised, double-blind trial in post-traumatic stress disorder (PTSD) comparing Risperidone with Placebo (2 arms). Primary endpoints: Clinician Administered PTSD Scale and Treatment Outcomes PTSD Scale. Started Jul 2001; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Risperidone
Participants receive risperidone monotherapy.
Placebo
Participants receive placebo.
03
Who it enrols
Women aged 19-64 with a DSM-IV diagnosis of PTSD caused by domestic violence or rape, excluding those with schizophrenia, bipolar I disorder, active substance dependence, or serious suicidal risk.
04
Endpoints
Primary
Clinician Administered PTSD Scale
Treatment Outcomes PTSD Scale
Secondary
Hamilton Rating Scale for Anxiety
Hamilton Rating Scale for Depression
Clinical Global Impression
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