Adults 18 to 60, any sex, with Schizophrenia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Measurement of Schizophrenia Symptoms: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score.Primary· Baseline to Week 6
The Positive and Negative Syndrome Scale is a 30-item rating scale specifically developed to asses both the positive and negative symptom syndromes of patients with schizophrenia. The PANSS total score is rated based on a structured clinical interview with the patient and supporting clinical information obtained from family, hospital staff, or other reliable informants. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point (1 to 7) scale, with 1 bein
Group
Value
95% CI
Placebo
-14.3
± 1.5
Cariprazine 3.0 mg
-20.2
± 1.5
Cariprazine 6.0mg
-23.0
± 1.5
Aripiprazole 10.0 mg
-21.2
± 1.4
Measurement of the Overall Severity of Illness: Change From Baseline in Clinical Global Impression-Severity (CGI-S)Secondary· Baseline to Week 6
The Clinical Global Impressions-Severity scale is a clinician-rated scale that measures the overall severity of a participant's illness in comparison with the severity of illness in other participants the physician has observed. The participant is rated on a scale from 1 to 7 with 1 indicating a "normal state" and 7 indicating "among the most extremely ill participants." A higher score indicates greater illness. A negative change from baseline score indicates improvement.
Group
Value
95% CI
Placebo
-1.0
± 0.1
Cariprazine 3.0 mg
-1.4
± 0.1
Cariprazine 6.0mg
-1.5
± 0.1
Aripiprazole 10.0 mg
-1.4
± 0.1
Adverse events — posted to ClinicalTrials.gov
Time frame: Assessed over 2 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of acute exacerbation of schizophrenia.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06433635 — Sequential Multiple Assignment Randomized Trial for Bipolar Depression
· Phase 4
· active not recruiting
NCT05913947 — Lithium Versus Cariprazine in the Acute Phase Treatment of Bipolar Depression (DUAG9)
· Phase 4
· recruiting
NCT05368558 — Study to Assess Adverse Events and Change in Disease Activity of Oral Cariprazine Capsules in Adult Participants With Sc
· Phase 3
· terminated
NCT05384483 — Cariprazine Versus Placebo for Social Anxiety Disorder
· Phase 4
· completed
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Currently open trials in the same condition.
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NCT07379827 — Effectiveness and Adverse-effect Switch Evaluation of Xanomeline and Trospium Chloride (KarXT)
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NCT06758414 — CBT-CP for Veterans With SMI
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NCT07395206 — Acceptability, Feasibility and Preliminary Outcomes of the Kiso Mind App for Outpatients With Schizophrenia Spectrum Dis
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Other Forest Laboratories trials
Trials by the same sponsor.
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· completed
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· Phase 2
· terminated
NCT02670538 — Study of the Efficacy of a Fixed-dose Regimen of Cariprazine Compared to Placebo for Treatment of the Depressive Episode
· Phase 3
· completed
NCT02670551 — Study on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I Depres
· Phase 3
· completed
NCT02559570 — A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 6-17 Years Who Fulfill
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Forest Laboratories
Last refreshed: 29 October 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01104766.