Trial · NCT00694707

Safety and Efficacy of Cariprazine (RGH-188) in the Acute Exacerbation of Schizophrenia

NCT00694707, Phase 2, Completed, Forest Laboratories; results first posted 2019-06-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy of Cariprazine (RGH-188) in the Acute Exacerbation of Schizophrenia. Trials, record NCT00694707. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00694707

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Trial

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

Title: Safety and Efficacy of Cariprazine (RGH-188) in the Acute Exacerbation of Schizophrenia
NCT number: NCT00694707
Status: Completed
Phases: Phase 2
Enrollment: 732 participants, actual
Lead sponsor: Forest Laboratories
Conditions: Schizophrenia
Interventions: Placebo, Cariprazine, Risperidone
First posted: 2008-06-10
Last updated: 2019-06-12
Results first posted: 2019-06-12

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Change From Baseline to Week 6 in the PANSS Total Score	Baseline to Week 6	The Positive and Negative Syndrome Scale (PANSS) is a 30-item rating scale that assesses the positive and negative symptoms of individuals with schizophrenia. Responses to the 30 items are based on a structured clinical interview with the patient and on supporting clinical information obtained from family, hospital staff, or other reliable informants. Of the 30 psychiatric parameters measured by the scale, 7 assess positive symptoms (eg, delusions, grandiosity); 7 assess negative symptoms (eg, blunted affect, emotional withdrawal); and 16 assess general psychopathology (eg, poor attention, active social avoidance). Each item is scored on a 7-point scale (1 = absent, 2 = minimal, 3 = mild, 4 = moderate, 5 = moderately severe, 6 = severe, and 7 = extreme). The PANSS total score can range from 30 to 210. A higher score indicates worse symptoms. A negative change score indicates improvement.
Secondary	Change From Baseline to Week 6 in the CGI-S Score	Baseline to Week 6	The Clinical Global Impressions-Severity (CGI-S) scale is a 7-point scale that measures the overall severity of the illness compared with the severity of illness in other patients the Investigator has observed. The Investigator assesses the severity of the patient's illness as one of the following: 1 = Normal, not at all ill; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill patients. The CGI-S score can range from 1 to 7. A higher score indicates more severe illness. A negative change score indicates improvement.

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline to Week 6 in the PANSS Total Score	Baseline to Week 6	Intent-to-treat population: All participants who took at least 1 dose of double-blind investigational product and who had at least 1 post-baseline assessment of the primary efficacy parameter, the PANSS total score.	Units on a scale	MEAN
SECONDARY	Change From Baseline to Week 6 in the CGI-S Score	Baseline to Week 6	Intent-to-treat population: All participants who took at least 1 dose of double-blind investigational product and who had at least 1 post-baseline assessment of the primary efficacy parameter, the PANSS total score.	Units on a scale	MEAN

Source ClinicalTrials.gov

Results by group20

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

Outcome	Group	Category	Value	Spread	Units
Change From Baseline to Week 6 in the PANSS Total Score	Placebo	Baseline	97.3	Standard Error 0.8	Units on a scale
Change From Baseline to Week 6 in the PANSS Total Score	Cariprazine 1.5 mg	Baseline	97.1	Standard Error 0.8	Units on a scale
Change From Baseline to Week 6 in the PANSS Total Score	Cariprazine 3.0 mg	Baseline	97.2	Standard Error 0.7	Units on a scale
Change From Baseline to Week 6 in the PANSS Total Score	Cariprazine 4.5 mg	Baseline	96.7	Standard Error 0.8	Units on a scale
Change From Baseline to Week 6 in the PANSS Total Score	Risperidone 4.0 mg	Baseline	98.1	Standard Error 0.8	Units on a scale
Change From Baseline to Week 6 in the PANSS Total Score	Placebo	Change at Week 6	-9.5	Standard Error 1.6	Units on a scale
Change From Baseline to Week 6 in the PANSS Total Score	Cariprazine 1.5 mg	Change at Week 6	-17.3	Standard Error 1.7	Units on a scale
Change From Baseline to Week 6 in the PANSS Total Score	Cariprazine 3.0 mg	Change at Week 6	-18.7	Standard Error 1.8	Units on a scale
Change From Baseline to Week 6 in the PANSS Total Score	Cariprazine 4.5 mg	Change at Week 6	-20.2	Standard Error 1.6	Units on a scale
Change From Baseline to Week 6 in the PANSS Total Score	Risperidone 4.0 mg	Change at Week 6	-25.3	Standard Error 1.7	Units on a scale

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow15

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	151
Overall Study	STARTED	Cariprazine 1.5 mg	145
Overall Study	STARTED	Cariprazine 3.0 mg	147
Overall Study	STARTED	Cariprazine 4.5 mg	148
Overall Study	STARTED	Risperidone 4.0 mg	141
Overall Study	COMPLETED	Placebo	79
Overall Study	COMPLETED	Cariprazine 1.5 mg	90
Overall Study	COMPLETED	Cariprazine 3.0 mg	96
Overall Study	COMPLETED	Cariprazine 4.5 mg	98
Overall Study	COMPLETED	Risperidone 4.0 mg	101

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events135

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
other	Nausea	Gastrointestinal disorders	Placebo	5	151
other	Nausea	Gastrointestinal disorders	Cariprazine 1.5 mg	7	145
other	Nausea	Gastrointestinal disorders	Cariprazine 3.0 mg	11	146
other	Nausea	Gastrointestinal disorders	Cariprazine 4.5 mg	11	147
other	Nausea	Gastrointestinal disorders	Risperidone 4.0 mg	9	140
other	Constipation	Gastrointestinal disorders	Placebo	6	151
other	Constipation	Gastrointestinal disorders	Cariprazine 1.5 mg	14	145
other	Constipation	Gastrointestinal disorders	Cariprazine 3.0 mg	9	146
other	Constipation	Gastrointestinal disorders	Cariprazine 4.5 mg	8	147
other	Constipation	Gastrointestinal disorders	Risperidone 4.0 mg	13	140

1 to 10 of 135Source ClinicalTrials.gov

See all 135 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	151
Total, all-cause mortality	Cariprazine 1.5 mg	0	145
Total, all-cause mortality	Cariprazine 3.0 mg	0	146
Total, all-cause mortality	Cariprazine 4.5 mg	0	147
Total, all-cause mortality	Risperidone 4.0 mg	0	140
Total, other adverse events	Placebo	67	151
Total, other adverse events	Cariprazine 1.5 mg	73	145
Total, other adverse events	Cariprazine 3.0 mg	74	146
Total, other adverse events	Cariprazine 4.5 mg	87	147
Total, other adverse events	Risperidone 4.0 mg	80	140

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers6

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
24412468	DERIVED	PubMed
26845266	DERIVED	PubMed
28692485	DERIVED	PubMed
30470662	DERIVED	PubMed
33854317	DERIVED	PubMed
34091867	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 comparisons0

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

None in this release.

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/NCT00694707

GET https://conductscience.org/api/trials/v1/NCT00694707/events?page=2

API reference For AI assistants