Trial · NCT00099983

Risperidone Treatment for Military Service Related Chronic Post Traumatic Stress Disorder

NCT00099983, Phase 2, Completed, US Department of Veterans Affairs; results first posted 2014-08-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Risperidone Treatment for Military Service Related Chronic Post Traumatic Stress Disorder. Trials, record NCT00099983. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00099983

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Risperidone Treatment for Military Service Related Chronic Post Traumatic Stress Disorder
NCT number: NCT00099983
Status: Completed
Phases: Phase 2
Enrollment: 296 participants, actual
Lead sponsor: US Department of Veterans Affairs
Conditions: Stress Disorders, Post-Traumatic
Interventions: Risperidone, Placebo
First posted: 2004-12-22
Last updated: 2014-08-22
Results first posted: 2014-08-22

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in CAPS Score From Baseline to Week 24	24 Weeks	The primary outcome measure for this study was the total score on the 34-item Clinician-Administered PTSD Scale (CAPS). This study was the intent-to-treat analysis of the improvement in PTSD symptoms from baseline to week-24 follow-up as measured by the CAPS. Total score range for the CAPS is 0-136 with higher values representing a worse outcome. This study was powered initially to detect a 9-point difference between the treatment groups in the CAPS change score.

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in CAPS Score From Baseline to Week 24	24 Weeks		units on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change in CAPS Score From Baseline to Week 24	Risperidone		-16.3	95% Confidence Interval -19.7 to -12.9	units on a scale
Change in CAPS Score From Baseline to Week 24	Sugar Pill		-12.5	95% Confidence Interval -15.7 to -9.4	units on a scale

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Risperidone	147
Overall Study	STARTED	Sugar Pill	149
Overall Study	COMPLETED	Risperidone	123
Overall Study	COMPLETED	Sugar Pill	124
Overall Study	NOT COMPLETED	Risperidone	24
Overall Study	NOT COMPLETED	Sugar Pill	25

Source ClinicalTrials.gov

Adverse events20

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
serious	Suicidal ideation	Psychiatric disorders	Risperidone	8	133	8
serious	Suicidal ideation	Psychiatric disorders	Sugar Pill	2	134	2
serious	Aggression	Psychiatric disorders	Risperidone	0	133	0
serious	Aggression	Psychiatric disorders	Sugar Pill	1	134	1
serious	Gastrooesphageal reflus Disease	Gastrointestinal disorders	Risperidone	0	133	0
serious	Gastrooesphageal reflus Disease	Gastrointestinal disorders	Sugar Pill	1	134	1
serious	Intestinal Obstruction	Gastrointestinal disorders	Risperidone	0	133	0
serious	Intestinal Obstruction	Gastrointestinal disorders	Sugar Pill	1	134	1
serious	Non-cardiac	General disorders	Risperidone	0	133	0
serious	Non-cardiac	General disorders	Sugar Pill	1	134	1

1 to 10 of 20Source ClinicalTrials.gov

See all 20 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Risperidone
Total, all-cause mortality	Sugar Pill
Total, other adverse events	Risperidone	0	133
Total, other adverse events	Sugar Pill	0	134
Total, serious adverse events	Risperidone	16	133
Total, serious adverse events	Sugar Pill	10	134

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
21813427	DERIVED	PubMed
26890894	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Risperidone vs Sugar Pill: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00099983

GET https://conductscience.org/api/trials/v1/NCT00099983/registered

API reference For AI assistants