Relapse Prevention Study in Patients With Schizophrenia (REPRIEVE)

Vanda Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Schizophrenia

Treatments: Drug: Placebo; Drug: Iloperidone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01291511

CILO522D2301

Details and patient eligibility

About

The purpose of this study is to determine whether Iloperidone is effective in the prevention of relapse in patients with schizophrenia

Enrollment: 635 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Patients must understand and be capable to communicate adequately with the study coordinator and to participate in cognitive testing.
• Patients must agree to cooperate with all tests and examinations required by the protocol, be willing to comply fully with treatment and able to ingest oral medication.
• Patients must understand the nature of the study and must sign an informed consent document.
• Patients will have a clear diagnosis of schizophrenia according to DSM-IV criteria for at least 1 year.
• Patients must need of ongoing psychiatric treatment and must have a documented reason why a change in treatment is needed which might lead to a clinical improvement
• At screening patients will have a Positive and Negative Syndrome Scale (PANSS) of no more than 100 and a Clinical Global Impression Scale (CGI) of no more than 5 (i.e. must not be severely ill or worse).
• Patients must be outpatients at the time of screening and have not been an inpatient to treat schizophrenia for at least 1 week prior to the screening visit.
• Patients must have a history of at least 2 prior episodes of relapse or impending relapse in the 2 years preceding the screening visit.

Exclusion Criteria:-

• Pregnant or nursing (lactating) women, or women who plan on conceiving during the course of the study.
• Patients who meet the DSM-IV criteria for schizophreniform disorder (295.40) and schizoaffective (295.70).
• Patients with active symptoms of any other primary psychiatric diagnosis (Axis I) or prominent Axis II disorder which would interfere with compliance to the protocol.
• Patients who have a diagnosis or history suggestive of chemical dependence, or drug-induced toxic psychosis in the preceding 6 months; diagnosis or history of abuse (except for nicotine and caffeine) within the past 3 months, or a clinical presentation possibly confounded by the use of recreational drugs or alcohol.
• Patients who have a positive urine drug screen (at the screening visit). If opiates are positive at screening and clearly due to the use of pain killing medication, the patient may be re screened after the medication has been discontinued and enrolled in the study if urine drug screen is negative.
• Note: Occasional users of recreational drugs other than cocaine, amphetamines, hallucinogens, or parenteral drugs may be recruited. Patients who are dependent on nicotine, caffeine, or theophylline are allowed to enter the study.
• Patients who are mentally disabled (moderate to severe).
• Patients who have had a history of being in a coma for more than 24 hrs.
• Patients who have had thoughts of committing suicide within 6 months prior to screening or at baseline or suicide behaviors within 2 years prior to screening or at baseline.
• Patients thought to be of imminent risk of harm to others or in imminent legal difficulty.
• Patients under any form of legal compulsion to remain hospitalized or undergo treatment or assessment.
• Patients who have any disability that prevent them from completing any of the study requirements.
• Patients with a known clinically significant ECG abnormality including PR interval >240 msec, QRS complex >110 msec, QTcF >=450 msec, or congenital long QT syndrome based on central ECG reading results
• Treatment naive, first episode patients,
• Patients taking iloperidone at the screening visit or with a known hypersensitivity to drugs chemically related to benzioxazoles.
• Note: Active medical conditions that are minor or well-controlled are not exclusionary if they do not affect risk to the patient or the study results.

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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635 participants in 2 patient groups, including a placebo group

Iloperidone

Experimental group

Description:

After meeting all entry criteria, completing a 1-week open-label iloperidone titation period (up to 12 mg/day), followed by a 14-24 week open-label iloperidone flexible dose-stabilization period (up to 24 mg/day), approximately 260 patients will be randomized to one of two arms in a 1:1 ratio of iloperidone (flexible dosing 8-24 mg/day) to placebo. Post-randomization double-blind study medication will be administered orally twice daily for up to 26 weeks to evaluate relapse prevention. Subsequently, during the extension period, after a 1-week mock double-blind titration, open-label iloperidone (8-24 mg/day) is administered for up to 51 weeks to evaluate long-term safety.

Treatment:

Drug: Iloperidone

Placebo

Placebo Comparator group

Description:

Post-randomization matching placebo is administered orally bid during the double-blind period.

Treatment:

Drug: Placebo