Study of CYR-101 in Patients With Schizophrenia

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00861796
• Date of registration: 11/03/2009
• Prospective Registration: No
• Primary sponsor: Cyrenaic Pharmaceuticals
• Public title: Study of CYR-101 in Patients With Schizophrenia
• Scientific title: A Multi-center, Inpatient and Ambulatory, Phase 2, Double Blind, Randomized, Placebo-controlled Proof of Concept Study of CYR-101 in Patients With DSM-IV Schizophrenia
• Date of first enrolment: March 2008
• Target sample size: 100
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00861796
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

France

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Schizophrenia

Intervention(s)

Drug: Placebo

Drug: CYR-101

Primary Outcome(s)

Global PANSS score and sub-scores [Time Frame: one month (28 days +/- 2 days)]

Secondary Outcome(s)

PANSS total score and sub-scores [Time Frame: Three months (84 days +/- 2 days)]

CGI-S, DAI-10, PSQI, BACS, MADRS, HAMA. [Time Frame: three months (84 days +/- 2 days)]

Secondary ID(s)

CYR-101C01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors