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Relapse Prevention Study in Patients With Schizophrenia (REPRIEVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01291511
Recruitment Status : Completed
First Posted : February 8, 2011
Last Update Posted : June 13, 2016
Sponsor:
Information provided by (Responsible Party):
Vanda Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE February 3, 2011
First Posted Date  ICMJE February 8, 2011
Last Update Posted Date June 13, 2016
Study Start Date  ICMJE February 2011
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2012)
To determine the efficacy of flexible dosing of iloperidone compared with placebo in relapse prevention with evaluation of patients by psychiatric rating scales. [ Time Frame: up to 26 weeks post-randomization ]
Time to relapse is the time from the first dose of double-blind study medication to the assessment at which the first time of relapse or impending relapse is identified.
Original Primary Outcome Measures  ICMJE
 (submitted: February 5, 2011)
To determine the efficacy of flexible dosing of iloperidone compared with placebo in relapse prevention with evaluation of patients by psychiatric rating scales. [ Time Frame: up to 26 weeks ]
Change History Complete list of historical versions of study NCT01291511 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2012)
  • To explore the long-term safety and tolerability of flexible dosing of iloperidone (8, 12, 16, 20, or 24 mg/day given bid) [ Time Frame: baseline, weekly for 1 month, then at 2-4 week intervals up to 26 weeks ]
    Exploration of safety during the double-blind period includes frequency of treatment emergent adverse events and frequency of clinically notable abnormalities in vital signs, ECGs, and laboratory parameters; assessment of suicidal ideation and behavior using the C-SSRS will occur at each visit.
  • To explore the long-term efficacy of flexible dosing of iloperidone (8, 12, 16, 20, or 24 mg/day given bid) as measured by psychiatric rating scales. [ Time Frame: randomization, weekly for 1 month, every 2-4 weeks through week 34, every 12-16 weeks up to week 78 ]
    Psychiatric rating scales to explore efficacy include the Positive and Negative Syndrome Scale (total score and subscale scores), Clinical Global Impression of Severity and Improvement, and Sheehan Disability Scale.
  • To explore the long-term safety and tolerability of flexible dosing of iloperidone (8-24 mg/day) over an additional optional 52 weeks of treatment (open-label extension phase). [ Time Frame: baseline, every 2-4 weeks for up to 52 weeks ]
    Exploration of safety during the extension period includes frequency of treatment emergent adverse events and frequency of clinically notable abnormalities in vital signs, ECGs, and laboratory parameters; assessment of suicidal ideation and behavior using the C-SSRS rating scale will be performed at each visit.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2011)
  • To explore the long-term safety and tolerability of flexible dosing of iloperidone (8, 12, 16, 20, or 24 mg/day given bid) [ Time Frame: up to 26 weeks ]
  • Measure: To explore the long-term efficacy of flexible dosing of iloperidone (8, 12, 16, 20, or 24 mg/day given bid) as measured by psychiatric rating scales. [ Time Frame: up to 78 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Relapse Prevention Study in Patients With Schizophrenia
Official Title  ICMJE A Multicenter, Randomized, Double-blind Placebo-controlled, Parallel-group Study to Evaluate Prevention of Relapse in Patients With Schizophrenia Receiving Either Flexible Double Iloperiodone (Fanapt) or Placebo in Long-term Use (up to 26 Weeks) Followed by up to 52 Weks of Open-label Extension
Brief Summary The purpose of this study is to determine whether Iloperidone is effective in the prevention of relapse in patients with schizophrenia
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • Drug: Iloperidone
    Iloperidone capsules/tablets will be administered orally using a bid schedule; the strengths used include 1, 2, 4, 6, 8, 10, and 12 mg.
  • Drug: Placebo
    Matching placebo capsules will be administered orally duins a bid schedule during the double-blind period.
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Drug: Iloperidone
  • Placebo Comparator: Iloperidone (including Placebo)
    Post-randomization matching placebo is administered orally bid during the double-blind period.
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 5, 2014)
303
Original Estimated Enrollment  ICMJE
 (submitted: February 5, 2011)
710
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India,   Ukraine,   United States
Removed Location Countries Russian Federation,   South Africa
 
Administrative Information
NCT Number  ICMJE NCT01291511
Other Study ID Numbers  ICMJE CILO522D2301
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vanda Pharmaceuticals
Study Sponsor  ICMJE Vanda Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Vanda Pharmaceuticals
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP