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This is a study designed to evalute the safety and efficacy of RGH-188 in the treatment of acute schizophrenia. This study will be 10 weeks in duration; 6 weeks double-blind treatment, and 4 weeks safety follow-up. All patients meeting the eligibility criteria will be randomized to one of the three treatment groups--one of two doses of RGH-188 or placebo
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RGH-188 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| PANSS Total Score |
| Measure | Description | Time Frame |
|---|---|---|
| CGI-S |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For information regarding investigative sites, contact Forest Professional Affairs | St Louis | Missouri | 63045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34091867 | Derived | Laszlovszky I, Barabassy A, Nemeth G. Cariprazine, A Broad-Spectrum Antipsychotic for the Treatment of Schizophrenia: Pharmacology, Efficacy, and Safety. Adv Ther. 2021 Jul;38(7):3652-3673. doi: 10.1007/s12325-021-01797-5. Epub 2021 Jun 6. | |
| 33854317 | Derived | Barabassy A, Sebe B, Acsai K, Laszlovszky I, Szatmari B, Earley WR, Nemeth G. Safety and Tolerability of Cariprazine in Patients with Schizophrenia: A Pooled Analysis of Eight Phase II/III Studies. Neuropsychiatr Dis Treat. 2021 Apr 7;17:957-970. doi: 10.2147/NDT.S301225. eCollection 2021. |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C533287 | cariprazine |
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| 28692485 | Derived | Earley W, Durgam S, Lu K, Laszlovszky I, Debelle M, Kane JM. Safety and tolerability of cariprazine in patients with acute exacerbation of schizophrenia: a pooled analysis of four phase II/III randomized, double-blind, placebo-controlled studies. Int Clin Psychopharmacol. 2017 Nov;32(6):319-328. doi: 10.1097/YIC.0000000000000187. |