Relapse Prevention Study in Patients With Schizophrenia

• Register: ClinicalTrials.gov
• Last refreshed on: 25 July 2023
• Main ID: NCT01291511
• Date of registration: 03/02/2011
• Prospective Registration: No
• Primary sponsor: Vanda Pharmaceuticals
• Public title: Relapse Prevention Study in Patients With Schizophrenia REPRIEVE
• Scientific title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate Prevention of Relapse in Patients With Schizophrenia Receiving Either Flexible Dose Iloperidone or Placebo in Long-term Use (up to 26 Weeks) Followed by up to 52 Weeks of Open-label Extension
• Date of first enrolment: February 2011
• Target sample size: 635
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT01291511
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

India, Russian Federation, South Africa, Ukraine, United States

Key inclusion & 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



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

Health Condition(s) or Problem(s) studied

Schizophrenia

Intervention(s)

Drug: Placebo

Drug: Iloperidone

Primary Outcome(s)

Time to Relapse or Impending Relapse [Time Frame: Up to 26 weeks post-randomization]

Secondary Outcome(s)

SDS Total Score, Change From Baseline to Last Visit [Time Frame: Up to 26 weeks post-randomization]

CGI-S, Last Visit [Time Frame: Up to 26 weeks post-randomization]

PANSS Total Score, Change From Baseline to Last Visit [Time Frame: Up to 26 weeks post-randomization]

Secondary ID(s)

CILO522D2301

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 17/07/2023
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01291511