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.
Time From Baseline to the First Symptom Relapse During the Double-blind PhasePrimary· Up to 34 Weeks and Bi-Weekly thereafter until Week 92
Relapse was defined as meeting ≥1 of the following criteria:1-Hospitalization due to worsening of condition;2-increase in Positive and Negative Syndrome Scale(PANSS) total score by ≥30% for participants,scored ≥50 or a ≥10-point increase for participants,scored \<50 at randomization;3-increase in Clinical Global Impressions-Severity(CGI-S) score by ≥2 points at Week 20;4-deliberate self-injury or aggressive behaviour;5-suicidal/homicidal ideation judged clinically significant by Investigator;6-score of \>4 on 1 or more of following PANSS items:P1,P2,P3,P6,P7,G8 or G14. Second assessment not pe
Group
Value
95% CI
Placebo
92
44 – 151
Cariprazine
224
99 – NA
Adverse events — posted to ClinicalTrials.gov
Time frame: First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)].
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 and safety of cariprazine relative to placebo in the prevention of relapse of symptoms in participants with 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
Other recruiting trials for Schizophrenia
Currently open trials in the same condition.
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· Phase 3
· recruiting
NCT07467993 — Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With Schizophrenia
· Phase 2
· recruiting
NCT07379827 — Effectiveness and Adverse-effect Switch Evaluation of Xanomeline and Trospium Chloride (KarXT)
· recruiting
NCT06758414 — CBT-CP for Veterans With SMI
· NA
· recruiting
NCT07395206 — Acceptability, Feasibility and Preliminary Outcomes of the Kiso Mind App for Outpatients With Schizophrenia Spectrum Dis
· NA
· recruiting
Other Forest Laboratories trials
Trials by the same sponsor.
NCT02788617 — Evaluation of the Efficacy of Diafert in Predicting Embryos' Potential to Develop to the Blastocyst Stage
· completed
NCT02732327 — Comparative Study of Ceftazidime-Avibactam Versus Standard of Care as Therapy in Febrile Neutropenic Adults With Cancer
· 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
· Phase 2
· completed
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: 6 July 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/NCT01412060.