Clinical trial NCT01291511: Relapse Prevention Study in Patients With Schizophrenia
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Schizophrenia
Mental Disorders
Antipsychotic Agents
Iloperidone
Relapse Prevention
Lead sponsor: Vanda Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-02-08
Enrollment: 635
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Time to Relapse or Impending Relapse
timeFrame: Up to 26 weeks post-randomization
Secondary outcomes:
measure: PANSS Total Score, Change From Baseline to Last Visit
timeFrame: Up to 26 weeks post-randomization
measure: CGI-S, Last Visit
timeFrame: Up to 26 weeks post-randomization
measure: SDS Total Score, Change From Baseline to Last Visit
timeFrame: Up to 26 weeks post-randomization
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Vanda Investigative Site
state: California
city: Bellflower
country: United States
facility: Vanda Investigative Site
state: California
city: Costa Mesa
country: United States
facility: Vanda Investigative Site
state: California
city: Escondido
country: United States
facility: Vanda Investigative Site
state: California
city: La Habra
country: United States
facility: Vanda Investigative Site
state: California
city: Oceanside
country: United States
facility: Vanda Investigative Site
state: California
city: Orange
country: United States
facility: Vanda Investigative Site
state: California
city: Pico Rivera
country: United States
facility: Vanda Investigative Site
state: California
city: Riverside
country: United States
facility: Vanda Investigative Site
state: California
city: San Diego
country: United States
facility: Vanda Investigative Site
state: California
city: San Diego
country: United States
facility: Vanda Investigative Site
state: California
city: San Diego
country: United States
facility: Vanda Investigative Site
state: California
city: Santa Ana
country: United States
facility: Vanda Investigative Site
state: California
city: Melbourne
country: United States
facility: Vanda Investigative Site
state: Florida
city: Miami
country: United States
facility: Vanda Investigative Site
state: Florida
city: Oakland Park
country: United States
facility: Vanda Investigative Site
state: Florida
city: Atlanta
country: United States
facility: Vanda Investigative Site
state: Georgia
city: Atlanta
country: United States
facility: Vanda Investigative Site
state: Georgia
city: Saint Louis
country: United States
facility: Vanda Investigative Site
state: Missouri
city: Nashua
country: United States
facility: Vanda Investigative Site
state: New Hampshire
city: Marlton
country: United States
facility: Vanda Investigative Site
state: New Jersey
city: Brooklyn
country: United States
facility: Vanda Investigative Site
state: New York
city: Staten Island
country: United States
facility: Vanda Investigative Site
state: New York
city: Hickory
country: United States
facility: Vanda Investigative Site
state: North Carolina
city: Beachwood
country: United States
facility: Vanda Investigative Site
state: Ohio
city: Philadelphia
country: United States
facility: Vanda Investigative Site
state: Pennsylvania
city: Irving
country: United States
facility: Vanda Investigative Site
state: Texas
city: Salt Lake City
country: United States
facility: Vanda Investigative Site
state: Utah
city: Ahmedabad
country: India
facility: Vanda Investigative Site
state: Gujarat
city: Madhava Nagar
country: India
facility: Vanda Investigative Site
state: Karnataka
city: Mangalore
country: India
facility: Vanda Investigative Site
state: Karnataka
city: Mangalore
country: India
facility: Vanda Investigative Site
state: Karnataka
city: Mysore
country: India
facility: Vanda Investigative Site
state: Karnataka
city: Nashik
country: India
facility: Vanda Investigative Site
state: Maharashtra
city: Pune
country: India
facility: Vanda Investigative Site
state: Maharashtra
city: Jaipur
country: India
facility: Vanda Investigative Site
state: Rajasthan
city: Madurai
country: India
facility: Vanda Investigative Site
state: Tamilnadu
city: Kanpur
country: India
facility: Vanda Investigative Site
state: Uttar Pradesh
city: Lucknow
country: India
facility: Vanda Investigative Site
state: Uttar Pradesh
city: Lucknow
country: India
facility: Vanda Investigative Site
state: Uttar Pradesh
city: Varanasi
country: India
facility: Vanda Investigative Site
state: Uttar Pradesh
city: Kerch
country: Ukraine
facility: Vanda Investigative Site
state: AR Crimea
city: Yevpatoriya
country: Ukraine
facility: Vanda Investigative Site
state: AR Crimea
city: Chernihiv
country: Ukraine
facility: Vanda Investigative Site
city: Dnipropetrovsk
country: Ukraine
facility: Vanda Investigative Site
city: Dnipropetrovsk
country: Ukraine
facility: Vanda Investigative Site
city: Donetsk
country: Ukraine
facility: Vanda Investigative Site
city: Donezk
country: Ukraine
facility: Vanda Investigative Site
city: Ivano-Frankivsk
country: Ukraine
facility: Vanda Investigative Site
city: Kharkiv
country: Ukraine
facility: Vanda Investigative Site
city: Kharkiv
country: Ukraine
facility: Vanda Investigive Site
city: Kyiv
country: Ukraine
facility: Vanda Investigative Site
city: Kyiv
country: Ukraine
facility: Vanda Investigative Site
city: Kyiv
country: Ukraine
facility: Vanda Investigative Site
city: Kyiv
country: Ukraine
facility: Vanda Investigative Site
city: Lugansk
country: Ukraine
facility: Vanda Investigative Site
city: Odesa
country: Ukraine
facility: Vanda Investigative Site
city: Poltava
country: Ukraine
facility: Vanda Investigative Site
city: Simferopol
country: Ukraine
facility: Vanda Investigative Site
city: Stepanivka
country: Ukraine
facility: Vanda Investigative Site
city: Ternopil
country: Ukraine
facility: Vanda Investigative Site
city: Uzhgorod
country: Ukraine
facility: Vanda Investigative Site
city: Vinnytsya
country: Ukraine
facility: Vanda Investigative Site
Study officials:
References:
citation: 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.