Phase 2 Completed N=296 Randomized Quadruple-blind Treatment

Risperidone Treatment for Military Service Related Chronic Post Traumatic Stress Disorder

Stress · Post-Traumatic

Source: ClinicalTrials.gov NCT00099983 ↗

Enrolled (actual)

296

Serious AEs

9.7%

Results posted

Aug 2014

Primary outcomePrimary: Change in CAPS Score From Baseline to Week 24 — -16.3; -12.5 units on a scale

Summary

The purpose of this research of 400 participants is to determine whether a drug called risperidone can decrease symptoms of Post-Traumatic Stress Disorder (PTSD). It is a placebo-controlled study, meaning that half of the participants will be assigned to receive a pill that contains no drug. The treatment phase of the study will last for 6 months, during which time participants will continue to receive all their usual treatments in addition to the study treatment and will be asked to complete procedures and assessments (questionnaires, interviews, laboratory tests, physical exams, etc.) related to their PTSD symptoms at various points within the 6-month treatment phase. At the end of the 6-month study, participants will discontinue the study treatment.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in CAPS Score From Baseline to Week 24	-16.3; -12.5	—

Eligibility Criteria

Inclusion Criteria

18 years or older
Military service related chronic PTSD
CAPS score >50
Participant in VA outpatient PTSD clinic
History of non-response to two or more antidepressants

Exclusion Criteria

Comorbid Axis I diagnosis requiring antipsychotic medication
Substance dependence diagnosis (excluding nicotine)
Hepatic or renal problems
Incompatible medical diagnosis or medication (i.e., coumadin, insulin)
Unstable living arrangements
Assault or suicide gesture within 1 year

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00099983). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.