Safety and Efficacy of Cariprazine in Patients With Schizophrenia

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01104766
• Date of registration: 09/04/2010
• Prospective Registration: Yes
• Primary sponsor: Forest Laboratories
• Public title: Safety and Efficacy of Cariprazine in Patients With Schizophrenia
• Scientific title: A Double-Blind, Placebo and Active-Controlled Evaluation of the Safety and Efficacy of Cariprazine in the Acute Exacerbation of Schizophrenia
• Date of first enrolment: April 23, 2010
• Target sample size: 617
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01104766
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Romania, Russian Federation, Ukraine, United States

Contacts

• Name: Raffaele Migliore, MA
• Affiliation: Forest Laboratories

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients who have provided informed consent prior to any study specific procedures

- Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders,
Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia (paranoid type,
disorganized type, catatonic type or undifferentiated type), as confirmed by the
Structured Clinical Interview for Diagnostic and Statistical Manual of Mental
Disorders, Fourth Edition (SCID)

- Patients with normal physical examination, laboratory, vital signs,and/ or
electrocardiogram (ECG)

- Current psychotic episode (schizophrenia exacerbation) < 2 weeks duration at Visit 1

- Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCIPANSS)
total score = 80 and = 120

- CGI-S score = 4

Exclusion Criteria:

- Schizoaffective disorder, schizophreniform disorder, and other psychotic disorders

- Bipolar I and II disorder

- Pervasive developmental disorder, mental retardation, delirium, dementia, amnestic and
other cognitive disorders

- DSM-IV-TR axis II disorder of sufficient severity to interfere with participation in
this study

- Women who are pregnant or breast feeding



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Schizophrenia

Intervention(s)

Drug: Aripiprazole

Drug: Placebo

Drug: Cariprazine

Primary Outcome(s)

Measurement of Schizophrenia Symptoms: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score. [Time Frame: Baseline to Week 6]

Secondary Outcome(s)

Measurement of the Overall Severity of Illness: Change From Baseline in Clinical Global Impression-Severity (CGI-S) [Time Frame: Baseline to Week 6]

Secondary ID(s)

RGH-MD-04

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Gedeon Richter Ltd.

Results

• Results available: Yes
• Date Posted: 29/10/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01104766