Relapse Prevention Study in Patients With Schizophrenia (REPRIEVE)
This study is currently recruiting participants.
Verified February 2013 by Novartis
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
First received: February 3, 2011
Last updated: February 7, 2013
Last verified: February 2013
The purpose of this study is to determine whether Iloperidone is effective in the prevention of relapse in patients with schizophrenia
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||December 2018|
|Estimated Primary Completion Date:||December 2018 (Final data collection date for primary outcome measure)|
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01291511
Show 115 Study Locations
|Contact: Novartis Pharmaceuticals||+1(862)778-8300|
Show 115 Study Locations
Sponsors and Collaborators
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|