Relapse Prevention Study in Patients With Schizophrenia
NCT ID: NCT01291511
Last Updated: 2023-07-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
635 participants
INTERVENTIONAL
2011-02-28
2015-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Iloperidone
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.
Iloperidone
Over-encapsulated iloperidone tablets were administered orally using a bid schedule; the strengths used include 1, 2, 4, 6, 8, 10, and 12 mg.
Placebo
Post-randomization matching placebo is administered orally bid during the double-blind period.
Placebo
Matching placebo capsules were administered orally using a bid schedule during the double-blind period.
Interventions
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Iloperidone
Over-encapsulated iloperidone tablets were administered orally using a bid schedule; the strengths used include 1, 2, 4, 6, 8, 10, and 12 mg.
Placebo
Matching placebo capsules were administered orally using a bid schedule during the double-blind period.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Vanda Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Vanda Investigative Site
Anaheim, California, United States
Vanda Investigative Site
Bellflower, California, United States
Vanda Investigative Site
Costa Mesa, California, United States
Vanda Investigative Site
Escondido, California, United States
Vanda Investigative Site
La Habra, California, United States
Vanda Investigative Site
Oceanside, California, United States
Vanda Investigative Site
Orange, California, United States
Vanda Investigative Site
Pico Rivera, California, United States
Vanda Investigative Site
Riverside, California, United States
Vanda Investigative Site
San Diego, California, United States
Vanda Investigative Site
San Diego, California, United States
Vanda Investigative Site
San Diego, California, United States
Vanda Investigative Site
Santa Ana, California, United States
Vanda Investigative Site
Melbourne, Florida, United States
Vanda Investigative Site
Miami, Florida, United States
Vanda Investigative Site
Oakland Park, Florida, United States
Vanda Investigative Site
Atlanta, Georgia, United States
Vanda Investigative Site
Atlanta, Georgia, United States
Vanda Investigative Site
St Louis, Missouri, United States
Vanda Investigative Site
Nashua, New Hampshire, United States
Vanda Investigative Site
Marlton, New Jersey, United States
Vanda Investigative Site
Brooklyn, New York, United States
Vanda Investigative Site
Staten Island, New York, United States
Vanda Investigative Site
Hickory, North Carolina, United States
Vanda Investigative Site
Beachwood, Ohio, United States
Vanda Investigative Site
Philadelphia, Pennsylvania, United States
Vanda Investigative Site
Irving, Texas, United States
Vanda Investigative Site
Salt Lake City, Utah, United States
Vanda Investigative Site
Ahmedabad, Gujarat, India
Vanda Investigative Site
Madhava Nagar, Karnataka, India
Vanda Investigative Site
Mangalore, Karnataka, India
Vanda Investigative Site
Mangalore, Karnataka, India
Vanda Investigative Site
Mysore, Karnataka, India
Vanda Investigative Site
Nashik, Maharashtra, India
Vanda Investigative Site
Pune, Maharashtra, India
Vanda Investigative Site
Jaipur, Rajasthan, India
Vanda Investigative Site
Madurai, Tamil Nadu, India
Vanda Investigative Site
Kanpur, Uttar Pradesh, India
Vanda Investigative Site
Lucknow, Uttar Pradesh, India
Vanda Investigative Site
Lucknow, Uttar Pradesh, India
Vanda Investigative Site
Varanasi, Uttar Pradesh, India
Vanda Investigative Site
Kerch, AR Crimea, Ukraine
Vanda Investigative Site
Yevpatoria, AR Crimea, Ukraine
Vanda Investigative Site
Chernihiv, , Ukraine
Vanda Investigative Site
Dnipropetrovsk, , Ukraine
Vanda Investigative Site
Dnipropetrovsk, , Ukraine
Vanda Investigative Site
Donetsk, , Ukraine
Vanda Investigative Site
Donetsk, , Ukraine
Vanda Investigative Site
Ivano-Frankivsk, , Ukraine
Vanda Investigative Site
Kharkiv, , Ukraine
Vanda Investigive Site
Kharkiv, , Ukraine
Vanda Investigative Site
Kyiv, , Ukraine
Vanda Investigative Site
Kyiv, , Ukraine
Vanda Investigative Site
Kyiv, , Ukraine
Vanda Investigative Site
Kyiv, , Ukraine
Vanda Investigative Site
Luhansk, , Ukraine
Vanda Investigative Site
Odesa, , Ukraine
Vanda Investigative Site
Poltava, , Ukraine
Vanda Investigative Site
Simferopol, , Ukraine
Vanda Investigative Site
Stepanovka, , Ukraine
Vanda Investigative Site
Ternopil, , Ukraine
Vanda Investigative Site
Uzhhorod, , Ukraine
Vanda Investigative Site
Vinnytsia, , Ukraine
Countries
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References
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Weiden PJ, Manning R, Wolfgang CD, Ryan JM, Mancione L, Han G, Ahmed S, Mayo MG. A Randomized Trial of Iloperidone for Prevention of Relapse in Schizophrenia: The REPRIEVE Study. CNS Drugs. 2016 Aug;30(8):735-47. doi: 10.1007/s40263-016-0345-4.
Other Identifiers
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CILO522D2301
Identifier Type: -
Identifier Source: org_study_id
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