Relapse Prevention Study in Patients With Schizophrenia (REPRIEVE)
|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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01291511
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|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|