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Relapse Prevention Study in Patients With Schizophrenia (REPRIEVE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01291511
First received: February 3, 2011
Last updated: November 6, 2014
Last verified: November 2014
  Purpose

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


Condition Intervention Phase
Schizophrenia
Drug: Iloperidone
Drug: Placebo
Phase 3

Study Type: Interventional
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:


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.


Estimated Enrollment: 303
Study Start Date: February 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Placebo Comparator: Iloperidone (including Placebo)
Post-randomization matching placebo is administered orally bid during the double-blind period.
Drug: Placebo
Matching placebo capsules will be administered orally duins a bid schedule during the double-blind period.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01291511

  Hide Study Locations
Locations
United States, California
Novartis Investigative Site
Anaheim, California, United States, 92804
Novartis Investigative Site
Costa Mesa, California, United States, 92626
Novartis Investigative Site
Escondido, California, United States, 92025
Novartis Investigative Site
La Habra, California, United States, 90631
Novartis Investigative Site
Oceanside, California, United States, 92056
Novartis Investigative Site
Orange, California, United States, 92869
Novartis Investigative Site
Paramount, California, United States, 90723
Novartis Investigative Site
Pico Rivera, California, United States, 90660
Novartis Investigative Site
Riverside, California, United States, 92506
Novartis Investigative Site
San Diego, California, United States, 92128
Novartis Investigative Site
San Diego, California, United States, 92108
Novartis Investigative Site
San Diego, California, United States, 92102
Novartis Investigative Site
Santa Ana, California, United States, 92705
United States, Florida
Novartis Investigative Site
Melbourne, Florida, United States, 32901
Novartis Investigative Site
Miami, Florida, United States, 33126
Novartis Investigative Site
Oakland Park, Florida, United States, 33334
United States, Georgia
Novartis Investigative Site
Atlanta, Georgia, United States, 30328
Novartis Investigative Site
Atlanta, Georgia, United States, 30308
United States, Missouri
Novartis Investigative Site
St. Louis, Missouri, United States, 63109
United States, New Hampshire
Novartis Investigative Site
Nashua, New Hampshire, United States, 03060
United States, New Jersey
Novartis Investigative Site
Willingboro, New Jersey, United States, 08046
United States, New York
Novartis Investigative Site
Brooklyn, New York, United States, 11235
Novartis Investigative Site
Staten Island, New York, United States, 10312
United States, North Carolina
Novartis Investigative Site
Hickory, North Carolina, United States, 28601
United States, Ohio
Novartis Investigative Site
Beachwood, Ohio, United States, 44122
United States, Pennsylvania
Novartis Investigative Site
Philadelphia, Pennsylvania, United States, 19149
United States, Texas
Novartis Investigative Site
Irving, Texas, United States, 75062
United States, Utah
Novartis Investigative Site
Salt Lake City, Utah, United States, 84106
India
Novartis Investigative Site
Ahmedabad, Gujarat, India, +91-380006
Novartis Investigative Site
Ahmedabad, Gujarat, India, 380013
Novartis Investigative Site
Bangalore, Karnataka, India, 560 055
Novartis Investigative Site
Mangalore, Karnataka, India, 575 003
Novartis Investigative Site
Manipal, Karnataka, India, 576104
Novartis Investigative Site
Mysore, Karnataka, India, 570 004
Novartis Investigative Site
Mangalore, Karna, India, 575018
Novartis Investigative Site
Mangalore, Karna, India, 575001
Novartis Investigative Site
Nashik, Maharashtra, India, 422 101
Novartis Investigative Site
Pune, Maharashtra, India, 411004
Novartis Investigative Site
Pune, Maharashtra, India, 411030
Novartis Investigative Site
Jaipur, Rajasthan, India, 302021
Novartis Investigative Site
Madurai, Tamilnadu, India, 625020
Novartis Investigative Site
Kanpur, Uttar Prad, India, 208005
Novartis Investigative Site
Lucknow, Uttar Prad, India, 226006
Novartis Investigative Site
Varanasi, Uttar Prad, India, 201010
Novartis Investigative Site
Lucknow, India, 226003
Ukraine
Novartis Investigative Site
Yevpatoriya, AR Crimea, Ukraine, 97416
Novartis Investigative Site
Chernigiv district, Chernigiv, Ukraine, 14000
Novartis Investigative Site
Dnipropetrovsk, Ukraine, 49005
Novartis Investigative Site
Dnipropetrovsk, Ukraine, 49115
Novartis Investigative Site
Donezk, Ukraine, 83008
Novartis Investigative Site
Ivano-Frankivsk, Ukraine, 76014
Novartis Investigative Site
Kerch, AR Crimea, Ukraine, '98310
Novartis Investigative Site
Kharkiv, Ukraine, 61068
Novartis Investigative Site
Kherson Vil. Stepanivka, Ukraine, 73488
Novartis Investigative Site
Kiev, Ukraine, 02660
Novartis Investigative Site
Kiev, Ukraine, 04080
Novartis Investigative Site
Kyiv, Ukraine, 04080
Novartis Investigative Site
Kyiv, Ukraine, 03049
Novartis Investigative Site
Kyiv region, Glevakha, Ukraine, 08631
Novartis Investigative Site
Lugansk, Ukraine, 91045
Novartis Investigative Site
Odesa, Ukraine, 65014
Novartis Investigative Site
Poltava, Ukraine, 36006
Novartis Investigative Site
Simferopol, Ukraine, 95006
Novartis Investigative Site
Ternopil, Ukraine, 46020
Novartis Investigative Site
Uzhgorod, Ukraine, 88000
Novartis Investigative Site
Vinnytsya, Ukraine, 21005
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01291511     History of Changes
Other Study ID Numbers: CILO522D2301
Study First Received: February 3, 2011
Last Updated: November 6, 2014
Health Authority: United States: Food and Drug Administration
India: Drugs Controller General of India
Ukraine: State Pharmacological Center - Ministry of Health

Keywords provided by Novartis:
Schizophrenia
Mental Disorders
Antipsychotic Agents
Iloperdione
Relapse Prevention

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 20, 2014