Study of CYR-101 in Patients With Schizophrenia

NCT00861796 | Completed Phase 2

• 1 other identifier: CYR-101C01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Global PANSS score and sub-scores

  one month (28 days +/- 2 days)

Secondary Outcomes (2)

• PANSS total score and sub-scores

  Three months (84 days +/- 2 days)

• CGI-S, DAI-10, PSQI, BACS, MADRS, HAMA.

  three months (84 days +/- 2 days)

Study Arms (2)

1

EXPERIMENTAL

Drug: CYR-101

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

CYR-101 DRUG

Experimental arm

1

Placebo DRUG

Placebo comparator

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cyrenaic Pharmaceuticals: lead

Study Sites (1)

Centre Hospitalier Universitaire de Nancy (CHU)

Toul, 54201, France

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 11, 2009
• First Posted: March 13, 2009
• Study Start: March 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: June 1, 2010
• Last Updated: June 8, 2011

Record last verified: 2011-05

Locations

FR (1)