Relapse Prevention Study in Patients With Schizophrenia

Schizophrenia Clinical Trial

— REPRIEVE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01291511
• Other study ID #: CILO522D2301
• Status: Completed
• Phase: Phase 3
• Start date: February 2011
• Est. completion date: March 2015

Study information

• Verified date: July 2023
• Source: Vanda Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 635
• Est. completion date: March 2015
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Recurrence
• Schizophrenia

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
India	Vanda Investigative Site	Ahmedabad	Gujarat
India	Vanda Investigative Site	Jaipur	Rajasthan
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	Madhava Nagar	Karnataka
India	Vanda Investigative Site	Madurai	Tamilnadu
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	Varanasi	Uttar Pradesh
Ukraine	Vanda Investigative Site	Chernihiv
Ukraine	Vanda Investigative Site	Dnipropetrovsk
Ukraine	Vanda Investigative Site	Dnipropetrovsk
Ukraine	Vanda Investigative Site	Donetsk
Ukraine	Vanda Investigative Site	Donezk
Ukraine	Vanda Investigative Site	Ivano-Frankivsk
Ukraine	Vanda Investigative Site	Kerch	AR Crimea
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	Lugansk
Ukraine	Vanda Investigative Site	Odesa
Ukraine	Vanda Investigative Site	Poltava
Ukraine	Vanda Investigative Site	Simferopol
Ukraine	Vanda Investigative Site	Stepanivka
Ukraine	Vanda Investigative Site	Ternopil
Ukraine	Vanda Investigative Site	Uzhgorod
Ukraine	Vanda Investigative Site	Vinnytsya
Ukraine	Vanda Investigative Site	Yevpatoriya	AR Crimea
United States	Vanda Investigative Site	Anaheim	California
United States	Vanda Investigative Site	Atlanta	Georgia
United States	Vanda Investigative Site	Atlanta	Georgia
United States	Vanda Investigative Site	Beachwood	Ohio
United States	Vanda Investigative Site	Bellflower	California
United States	Vanda Investigative Site	Brooklyn	New York
United States	Vanda Investigative Site	Costa Mesa	California
United States	Vanda Investigative Site	Escondido	California
United States	Vanda Investigative Site	Hickory	North Carolina
United States	Vanda Investigative Site	Irving	Texas
United States	Vanda Investigative Site	La Habra	California
United States	Vanda Investigative Site	Marlton	New Jersey
United States	Vanda Investigative Site	Melbourne	Florida
United States	Vanda Investigative Site	Miami	Florida
United States	Vanda Investigative Site	Nashua	New Hampshire
United States	Vanda Investigative Site	Oakland Park	Florida
United States	Vanda Investigative Site	Oceanside	California
United States	Vanda Investigative Site	Orange	California
United States	Vanda Investigative Site	Philadelphia	Pennsylvania
United States	Vanda Investigative Site	Pico Rivera	California
United States	Vanda Investigative Site	Riverside	California
United States	Vanda Investigative Site	Saint Louis	Missouri
United States	Vanda Investigative Site	Salt Lake City	Utah
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	Staten Island	New York

Sponsors (1)

Lead Sponsor	Collaborator
Vanda Pharmaceuticals

Countries where clinical trial is conducted

United States,  India,  Ukraine, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Relapse or Impending Relapse	Relapse or impending relapse was defined as any of the following: hospitalization due to worsening of schizophrenia; increase (worsening) of the PANSS total score of greater than or equal to 30% from randomization, PANSS total score confirmed at a second visit conducted within 1-7 days; clinically significant emergent or worsening suicidal, homicidal, or aggressive behavior; a CGI-Improvement (CGI-I) score of 6 (much worse) or 7 (very much worse) after randomization; a dose increase in study medication or a need for additional open-label antipsychotic treatment.	Up to 26 weeks post-randomization
Secondary	PANSS Total Score, Change From Baseline to Last Visit	The 30-item Positive and Negative Syndrome Scale (PANSS) was developed to assess the severity of symptoms of schizophrenia. The PANSS items are divided into positive, negative, and general psychopathology factors. All items were rated on a scale of 1 (absent) to 7 (extremely severe). The PANSS total score (or rating) is the sum of all 30 PANSS items taken together (the sum of its 3 subscales), with a maximum score of 210. Change from baseline is calculated as post value minus baseline value. A negative change indicates improvement.	Up to 26 weeks post-randomization
Secondary	CGI-S, Last Visit	The 7-item Clinical Global Impression of Severity (CGI-S) scale was developed to assess the overall, absolute degree of illness at any point in time. A rating of 1 is equivalent to "normal, not at all ill," and a rating of 7 is equivalent to "among the most extremely ill patients."	Up to 26 weeks post-randomization
Secondary	SDS Total Score, Change From Baseline to Last Visit	The Sheehan Disability Scale (SDS) a self-reported measure that was developed to assess functional impairment in 3 inter-related domains (i.e., work/school, social, and family life). It is a 10-point visual analog scale with 0 being not impaired at all and 10 extremely impaired. Change from baseline is calculated as post value minus baseline value. A negative change indicates improvement.	Up to 26 weeks post-randomization