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Study of CYR-101 in Patients With Schizophrenia
This study is currently recruiting participants.
Verified by Cyrenaic Pharmaceuticals, March 2009
First Received: March 11, 2009   Last Updated: March 12, 2009   History of Changes
Sponsored by: Cyrenaic Pharmaceuticals
Information provided by: Cyrenaic Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00861796
  Purpose

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
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

Resource links provided by NLM:


Further study details as provided by Cyrenaic Pharmaceuticals:

Primary Outcome Measures:
  • Global PANSS score and sub-scores [ Time Frame: one month (28 days +/- 2 days) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PANSS total score and sub-scores [ Time Frame: Three months (84 days +/- 2 days) ] [ Designated as safety issue: No ]
  • CGI-S, DAI-10, PSQI, BACS, MADRS, HAMA. [ Time Frame: three months (84 days +/- 2 days) ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: March 2008
Arms Assigned Interventions
1: Experimental Drug: CYR-101
2: Placebo Comparator Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients, 18 to 65 years of age, inclusive
  • Female patients must test negative for pregnancy and, if of childbearing potential, must be using a medically accepted means of contraception.
  • Patients must have a diagnosis of Schizophrenia or schizo-affective disorders as defined in Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revised (DSM-IV TR, APA 2000) (Disorganised, 295.10; Catatonic, 295.20; Paranoid, 295.30; Residual, 295.60; or Undifferentiated, 295.90) and confirmed by the Structured Clinical Interview for DSM-IV (SCID).
  • Patients must meet the following psychopathologic severity criteria at screening: Positive and Negative Syndrome Scale (PANSS) total score, of at least 60.
  • Patients must receive a rating of 4 (moderately ill) or greater on the Clinical Global Impression-Severity (CGI-S) scale at screening.
  • Patients in whom, in the opinion of the investigator, a switch to another antipsychotic medication or initiation of an antipsychotic medication is indicated.
  • Patients must be considered reliable, have a level of understanding sufficient to perform all tests and examinations required by the protocol.
  • Patients must be able to understand the nature of the study and have given their own informed consent.

Exclusion Criteria:

  • Are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
  • Have received treatment with a drug that has not received regulatory approval for any indication within 30 days prior to screening.
  • Patients in whom treatment with CYR-101, or placebo, as specified in this protocol, is relatively or absolutely clinically contraindicated.
  • Patients who have a history of an inadequate response, in the opinion of the investigator, to 2 or more adequate antipsychotic medication trials of at least 8 weeks duration in the past 12 months prior to screening.
  • Patients who require concomitant treatment with any other medication with primary central nervous system activity, other than certain allowed medications as specified in Study Protocol.
  • Patients receiving treatment with depot antipsychotic medication within 1 dosing interval, minimum of 4 weeks, prior to screening.
  • Actively suicidal (for example any suicide attempts within the past month or any current suicidal intent including plan) in the opinion of the investigator or a score of 4 or greater on Item 10 of the Montgomery-Asberg Depression Rating Scale (MADRS).
  • DSM-IV diagnosis of substance dependence or substance abuse (except nicotine and caffeine) within the 6 months prior to screening.
  • Diagnosis of substance-induced psychosis by DSM-IV criteria within 7 days of screening (or at any time during the study).
  • Patients with current heteroaggressive behavior.
  • Female patients who are pregnant, nursing, or who intend to become pregnant within 30 days of completing the study.
  • Have increased risk of seizures as evidenced by a history of: one or more seizures (except childhood febrile seizure), history of electroencephalogram (EEG) with epileptiform activity, history of stroke; surgery to the cerebral cortex; or head trauma with loss of consciousness. NOTE: patients with a history of childhood febrile seizure may be enrolled in this study.
  • Patients who have had electroconvulsive therapy (ECT) within 3 months of screening visit or who will have ECT at any time during the study.
  • Test HIV positive.
  • Test positive for Hepatitis C antibody or Hepatitis B surface antigen (HBsAg). Patients with positive Hepatitis B core antibody test and negative HBsAg may be included in the study if aminotransferase levels (ALT/SGPT and AST/SGOT) do not exceed 1.5 times upper limit of normal (ULN).
  • Alanine transaminase/serum glutamic-pyruvic transaminase (ALT/SGPT) values >1.5 times ULN of the performing laboratory, or total bilirubin values >2 times the ULN or concomitant ALT/SGPT values >1.5 times the ULN and total bilirubin values >1.5 times the ULN at screening.
  • Patients with acute, serious, or unstable medical conditions, including (but not limited to) inadequately controlled diabetes (hemoglobin A1c (HbA1c) >8%), severe hypertriglyceridemia (fasting triglycerides >5.6 mmol/L, recent cerebrovascular accidents, serious acute systemic infection or immunologic disease, unstable cardiovascular disorders (including ischemic heart disease), malnutrition, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic, or haematologic diseases.
  • Prolactin level at screening visit of greater than 200 ng/mL (or 200mg/L).
  • A diagnosis of Parkinson's disease, dementia-related psychosis, or related disorders. If a patient has a past misdiagnosis of Parkinson's disease, dementia-related psychosis, or related disorders, the investigator will need to contact the Clinical Research Physician prior to enrolment.
  • Patient with current clinically significant cardiovascular disease.
  • History of syncopal events due to cardiovascular abnormality.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00861796

Locations
France
Centre Hospitalier Universitaire de Nancy (CHU) Recruiting
Toul, France, 54201
Contact: Raymund SCHWAN, MD     +33 (0) 3 83 65 64 04        
Sponsors and Collaborators
Cyrenaic Pharmaceuticals
  More Information

No publications provided

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

Study placed in the following topic categories:
Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on September 10, 2009