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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT00694707 |
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Date of registration:
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06/06/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Safety and Efficacy of Cariprazine (RGH-188) in the Acute Exacerbation of Schizophrenia
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Scientific title:
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Evaluation of the Safety and Efficacy of RGH-188 in the Acute Exacerbation of Schizophrenia |
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Date of first enrolment:
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June 30, 2008 |
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Target sample size:
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732 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00694707 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 2
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Countries of recruitment
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India
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Malaysia
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Russian Federation
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Ukraine
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United States
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Contacts
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Name:
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Suresh Durgam, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Forest Laboratories |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Schizophrenia
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Intervention(s)
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Drug: Risperidone
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Drug: Placebo
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Drug: Cariprazine
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Primary Outcome(s)
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Change From Baseline to Week 6 in the PANSS Total Score
[Time Frame: Baseline to Week 6]
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Secondary Outcome(s)
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Change From Baseline to Week 6 in the CGI-S Score
[Time Frame: Baseline to Week 6]
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Secondary ID(s)
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RGH-MD-16
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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