SchizophreniaPhase 2NCT00861796
Study of CYR-101 in Patients With Schizophrenia
A Phase 2 study testing CYR-101 in people with Schizophrenia, run by Cyrenaic Pharmaceuticals at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- CYR-101
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2008to Jun 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 21Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
- Being tested
- CYR-101, Placebo
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYR-101Drug
Experimental arm
PlaceboDrug
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: CYR-101 |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global PANSS score and sub-scores
Measured: one month (28 days +/- 2 days)
Secondary outcomes (2)
PANSS total score and sub-scores
Measured: Three months (84 days +/- 2 days)
CGI-S, DAI-10, PSQI, BACS, MADRS, HAMA.
Measured: three months (84 days +/- 2 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2009 (estimated)
- Study startMar 2008
- Primary completionMay 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cyrenaic Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00861796
- Sponsor's protocol ID
- CYR-101C01
- Status last verified
- May 2011
- First submitted
- 11 Mar 2009
- Last updated
- 8 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00861796
- Acronym / sponsor ID
- CYR-101C01
- Conditions
- Schizophrenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cyrenaic PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- May 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 13 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: CYR-101 |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CYR-101Experimental arm | Drug | 1 |
| PlaceboPlacebo comparator | Drug | 2 |
Primary outcome
Global PANSS score and sub-scores
Time frame: one month (28 days +/- 2 days)
2 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CYR-101 in people with Schizophrenia, run by Cyrenaic Pharmaceuticals at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global PANSS score and sub-scores (time frame: one month (28 days +/- 2 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2011.