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Sponsored by: |
Cyrenaic Pharmaceuticals |
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Information provided by: | Cyrenaic Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00861796 |
This Phase II study will test whether CYR-101, a CNS-active compound with novel pharmacological profile and devoid of dopamine D2 receptor binding properties, is efficacious when administered orally in the management of patients with a diagnosis of DSM-IV schizophrenia.
Condition | Intervention | Phase |
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Schizophrenia |
Drug: CYR-101 Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Center, Inpatient and Ambulatory, Phase 2, Doubleblind, Randomised, Placebo-Controlled Proof of Concept Study of CYR-101 in Patients With DSM-IV Schizophrenia |
Estimated Enrollment: | 100 |
Study Start Date: | March 2008 |
Arms | Assigned Interventions |
---|---|
1: Experimental | Drug: CYR-101 |
2: Placebo Comparator | Drug: Placebo |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | ( Lorenzo Pellegrini ) |
Study ID Numbers: | CYR-101C01 |
Study First Received: | March 11, 2009 |
Last Updated: | March 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00861796 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Schizophrenia Mental Disorders Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |
Schizophrenia Mental Disorders Schizophrenia and Disorders with Psychotic Features |