Relapse Prevention Study in Patients With Schizophrenia (REPRIEVE)
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|ClinicalTrials.gov Identifier: NCT01291511|
Recruitment Status : Completed
First Posted : February 8, 2011
Last Update Posted : June 13, 2016
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: Iloperidone Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||303 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||March 2015|
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 capsules/tablets will be administered orally using a bid schedule; the strengths used include 1, 2, 4, 6, 8, 10, and 12 mg.
Placebo Comparator: Iloperidone (including Placebo)
Post-randomization matching placebo is administered orally bid during the double-blind period.
Matching placebo capsules will be administered orally duins a bid schedule during the double-blind period.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01291511
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|