A Study of Cariprazine in the Prevention of Relapse of Symptoms in Participants With Schizophrenia

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01412060
• Date of registration: 04/08/2011
• Prospective Registration: Yes
• Primary sponsor: Forest Laboratories
• Public title: A Study of Cariprazine in the Prevention of Relapse of Symptoms in Participants With Schizophrenia
• Scientific title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Cariprazine (RGH-188) in the Prevention of Relapse in Patients With Schizophrenia
• Date of first enrolment: September 27, 2011
• Target sample size: 765
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01412060
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

India, Romania, Slovakia, Ukraine, United States

Contacts

• Name: Willie Earley
• Affiliation: Allergan

Key inclusion & exclusion criteria

Inclusion Criteria:

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

- Participants currently meeting the Diagnostic and Statistical Manual of Mental
Disorders, Fourth Edition - Text Revision (DSM-IV-TR) criteria for schizophrenia.

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

- Diagnosis of schizophrenia for a minimum of 1 year before Visit 1 (Screening).

- Positive and Negative Syndrome Scale (PANSS) total score = to 70 and = 120 at Visit 1
(Screening) and Visit 2 (beginning of Run-in Phase).

- Negative serum B-human chorionic gonadotropin (B-hCG) pregnancy test (applies to
female participants of childbearing potential only).

- Body mass index between 18 and 40 kg/m^2, inclusive.

Exclusion Criteria:

- Participants currently meeting DSM-IV-TR criteria for schizoaffective disorder,
schizophreniform disorder, bipolar I and II and known or suspected borderline or
antisocial personality disorder. or other DSM-IV-TR axis II disorders.

- Participants in their first episode of psychosis.

- Treatment-resistant schizophrenia over the last 2 years.

- Positive result from the blood alcohol test or from the urine drug screen for any
prohibited medication.

- At imminent risk of injuring self or others or causing significant damage to property.

- Suicide risk.



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

Health Condition(s) or Problem(s) studied

Schizophrenia

Intervention(s)

Drug: Placebo

Drug: Cariprazine

Primary Outcome(s)

Time From Baseline to the First Symptom Relapse During the Double-blind Phase [Time Frame: Up to 34 Weeks and Bi-Weekly thereafter until Week 92]

Secondary ID(s)

RGH-MD-06

2011-002048-29

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Gedeon Richter Ltd.

Results

• Results available: Yes
• Date Posted: 06/07/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01412060