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Safety and Efficacy of Cariprazine (RGH-188) in the Acute Exacerbation of 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.
 
ClinicalTrials.gov Identifier: NCT00694707
Recruitment Status : Completed
First Posted : June 10, 2008
Results First Posted : June 12, 2019
Last Update Posted : June 12, 2019
Sponsor:
Collaborator:
Gedeon Richter Ltd.
Information provided by (Responsible Party):
Forest Laboratories

Brief Summary:
This is a study to evaluate the safety, efficacy, and tolerability of cariprazine (RGH-188) relative to placebo in adult patients (18-60 years of age) with acute exacerbation of schizophrenia.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Placebo Drug: Cariprazine Drug: Risperidone Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 732 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Safety and Efficacy of RGH-188 in the Acute Exacerbation of Schizophrenia
Actual Study Start Date : June 30, 2008
Actual Primary Completion Date : August 31, 2009
Actual Study Completion Date : August 31, 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Placebo Comparator: Placebo
Participants received placebo orally once a day for 6 weeks.
Drug: Placebo
Placebo was supplied in capsules.

Experimental: Cariprazine 1.5 mg
Participants received cariprazine 1.5 mg orally once a day for 6 weeks.
Drug: Cariprazine
Cariprazine was supplied in capsules
Other Name: RGH-188

Experimental: Cariprazine 3.0 mg
Participants received cariprazine 3.0 mg orally once a day for 6 weeks.
Drug: Cariprazine
Cariprazine was supplied in capsules
Other Name: RGH-188

Experimental: Cariprazine 4.5 mg
Participants received cariprazine 4.5 mg orally once a day for 6 weeks.
Drug: Cariprazine
Cariprazine was supplied in capsules
Other Name: RGH-188

Active Comparator: Risperidone 4.0 mg
Participants received risperidone 4.0 mg orally once a day for 6 weeks.
Drug: Risperidone
Risperidone was supplied in capsules
Other Name: Risperdal




Primary Outcome Measures :
  1. Change From Baseline to Week 6 in the PANSS Total Score [ Time Frame: Baseline to Week 6 ]
    The Positive and Negative Syndrome Scale (PANSS) is a 30-item rating scale that assesses the positive and negative symptoms of individuals with schizophrenia. Responses to the 30 items are based on a structured clinical interview with the patient and on supporting clinical information obtained from family, hospital staff, or other reliable informants. Of the 30 psychiatric parameters measured by the scale, 7 assess positive symptoms (eg, delusions, grandiosity); 7 assess negative symptoms (eg, blunted affect, emotional withdrawal); and 16 assess general psychopathology (eg, poor attention, active social avoidance). Each item is scored on a 7-point scale (1 = absent, 2 = minimal, 3 = mild, 4 = moderate, 5 = moderately severe, 6 = severe, and 7 = extreme). The PANSS total score can range from 30 to 210. A higher score indicates worse symptoms. A negative change score indicates improvement.


Secondary Outcome Measures :
  1. Change From Baseline to Week 6 in the CGI-S Score [ Time Frame: Baseline to Week 6 ]
    The Clinical Global Impressions-Severity (CGI-S) scale is a 7-point scale that measures the overall severity of the illness compared with the severity of illness in other patients the Investigator has observed. The Investigator assesses the severity of the patient's illness as one of the following: 1 = Normal, not at all ill; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill patients. The CGI-S score can range from 1 to 7. A higher score indicates more severe illness. A negative change score indicates improvement.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, 18 to 60 years of age.
  • Meets Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for schizophrenia (paranoid type, disorganized type, catatonic type, or undifferentiated type) based on a Structured Clinical Interview for DSM-IV (SCID).
  • Total Positive and Negative Syndrome Scale (PANSS) score ≥ 80 and ≤ 120.
  • Diagnosis of schizophrenia for at least 1 year.

Exclusion Criteria:

  • Abnormalities on physical examination or abnormal vital signs, electrocardiogram, or clinical laboratory values.
  • First episode of psychosis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00694707


Locations
Show Show 65 study locations
Sponsors and Collaborators
Forest Laboratories
Gedeon Richter Ltd.
Investigators
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Study Director: Suresh Durgam, MD Forest Laboratories

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT00694707    
Obsolete Identifiers: NCT00892528
Other Study ID Numbers: RGH-MD-16
First Posted: June 10, 2008    Key Record Dates
Results First Posted: June 12, 2019
Last Update Posted: June 12, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
Cariprazine
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents