Cariprazine Relative to Placebo in the Prevention of Relapse of Symptoms in Patients With Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01412060
Recruitment Status : Completed
First Posted : August 8, 2011
Last Update Posted : September 30, 2015
Gedeon Richter Ltd.
Information provided by (Responsible Party):
Forest Laboratories

August 4, 2011
August 8, 2011
September 30, 2015
August 2011
August 2014   (Final data collection date for primary outcome measure)
Time from baseline to the first symptom relapse during the Double-Blind phase [ Time Frame: At 17 Weeks and Bi-Weekly thereafter until week 92 ]
Same as current
Complete list of historical versions of study NCT01412060 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
Cariprazine Relative to Placebo in the Prevention of Relapse of Symptoms in Patients With Schizophrenia
A Randomized, Double-Blind, Placebo-controlled, Parallel-group Study of Cariprazine(RGH-188) in the Prevention of Relapse in Patients With Schizophrenia
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 patients with schizophrenia.
Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Drug: Cariprazine
    Patients who meet eligibility criteria will be administered a once daily oral dose of 3.0 to 9.0 mg cariprazine during the open-label phase and then randomized when they will receive cariprazine or placebo
  • Drug: Placebo
    Dose-matched placebo, once daily oral administration
  • Placebo Comparator: 1
    Intervention: Drug: Placebo
  • Experimental: 2
    Cariprazine, 3- 9mg/day (dosage depends on tolerability)
    Intervention: Drug: Cariprazine
Durgam S, Earley W, Li R, Li D, Lu K, Laszlovszky I, Fleischhacker WW, Nasrallah HA. Long-term cariprazine treatment for the prevention of relapse in patients with schizophrenia: A randomized, double-blind, placebo-controlled trial. Schizophr Res. 2016 Oct;176(2-3):264-271. doi: 10.1016/j.schres.2016.06.030. Epub 2016 Jul 15. Erratum in: Schizophr Res. 2018 Feb;192:493.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
November 2014
August 2014   (Final data collection date for primary outcome measure)

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 as confirmed by the
  • Patients with normal physical examination, laboratory, vital signs,and/ or ECG
  • Diagnosis of schizophrenia for a minimum of 1 year before Visit 1
  • Positive and Negative Syndrome Scale (PANSS) total score greater than or equal to 70 and less than or equal to 120 at Visit 1 and Visit 2
  • Negative serum B-human chorionic gonadotropin (B-hCG) pregnancy test (applies to female patients of childbearing potential only)
  • Body mass index between 18 and 40kg/m2, inclusive

Exclusion Criteria:

  • Patients 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
  • Patients 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
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
India,   Romania,   Slovakia,   Ukraine,   United States
2011-002048-29 ( EudraCT Number )
Not Provided
Not Provided
Forest Laboratories
Forest Laboratories
Gedeon Richter Ltd.
Study Director: Rui Li Forest Laboratories, Inc. a subsidiary of Actavis plc
Forest Laboratories
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP