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SchizophreniaPhase 3REPRIEVENCT01291511

Relapse Prevention Study in Patients With Schizophrenia

A Phase 3 study testing Iloperidone in people with Schizophrenia, run by Vanda Pharmaceuticals at 63 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Schizophrenia
What is being tested?
Iloperidone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
635 participants
Where
63 sitesin 3 countries
Study dates
Feb 2011to Mar 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 17Show fewer
  • 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

Trial locations and contacts

63 sites in 3 countries.

63 sites in 3 countries

United States28 sites

  • Vanda Investigative Site

    Anaheim, California, 92604

  • Vanda Investigative Site

    Atlanta, Georgia, 30308

  • Vanda Investigative Site

    Atlanta, Georgia, 30328

  • Vanda Investigative Site

    Beachwood, Ohio, 44122

  • Vanda Investigative Site

    Bellflower, California, 92706

  • Vanda Investigative Site

    Brooklyn, New York, 11235

  • Vanda Investigative Site

    Costa Mesa, California, 92626

  • Vanda Investigative Site

    Escondido, California, 92025

  • Vanda Investigative Site

    Hickory, North Carolina, 28601

  • Vanda Investigative Site

    Irving, Texas, 75062

  • Vanda Investigative Site

    La Habra, California, 90631

  • Vanda Investigative Site

    Marlton, New Jersey, 08053

  • Vanda Investigative Site

    Melbourne, Florida, 32901

  • Vanda Investigative Site

    Miami, Florida, 33126

  • Vanda Investigative Site

    Nashua, New Hampshire, 03060

  • Vanda Investigative Site

    Oakland Park, Florida, 33334

  • Vanda Investigative Site

    Oceanside, California, 92056

  • Vanda Investigative Site

    Orange, California, 92868

  • Vanda Investigative Site

    Philadelphia, Pennsylvania, 19139

  • Vanda Investigative Site

    Pico Rivera, California, 90660

  • Vanda Investigative Site

    Riverside, California, 92506

  • Vanda Investigative Site

    Salt Lake City, Utah, 84106

  • Vanda Investigative Site

    San Diego, California, 92102

  • Vanda Investigative Site

    San Diego, California, 92103

  • Vanda Investigative Site

    San Diego, California, 92121

  • Vanda Investigative Site

    Santa Ana, California, 92705

  • Vanda Investigative Site

    St Louis, Missouri, 63109

  • Vanda Investigative Site

    Staten Island, New York, 10312

Other trials in United States

Ukraine22 sites

  • Vanda Investigative Site

    Chernihiv, 14000

  • Vanda Investigative Site

    Dnipropetrovsk, 49005

  • Vanda Investigative Site

    Dnipropetrovsk, 49115

  • Vanda Investigative Site

    Donetsk, 83008

  • Vanda Investigative Site

    Donetsk, 83037

  • Vanda Investigative Site

    Ivano-Frankivsk, 76014

  • Vanda Investigative Site

    Kerch, AR Crimea, 98310

  • Vanda Investigative Site

    Kharkiv, 61068

  • Vanda Investigive Site

    Kharkiv, 68061

  • Vanda Investigative Site

    Kyiv, 01030

  • Vanda Investigative Site

    Kyiv, 02660

  • Vanda Investigative Site

    Kyiv, 04080

  • Vanda Investigative Site

    Kyiv, 08631

  • Vanda Investigative Site

    Luhansk, 91045

  • Vanda Investigative Site

    Odesa, 65014

  • Vanda Investigative Site

    Poltava, 36006

  • Vanda Investigative Site

    Simferopol, 95006

  • Vanda Investigative Site

    Stepanovka, 73488

  • Vanda Investigative Site

    Ternopil, 46020

  • Vanda Investigative Site

    Uzhhorod, 88000

  • Vanda Investigative Site

    Vinnytsia, 21005

  • Vanda Investigative Site

    Yevpatoriya, AR Crimea, 97416

Other trials in Ukraine

India13 sites

  • Vanda Investigative Site

    Ahmedabad, Gujarat, 380013

  • Vanda Investigative Site

    Jaipur, Rajasthan, 302021

  • Vanda Investigative Site

    Kanpur, Uttar Pradesh, 208005

  • Vanda Investigative Site

    Lucknow, Uttar Pradesh, 226003

  • Vanda Investigative Site

    Lucknow, Uttar Pradesh, 226006

  • Vanda Investigative Site

    Madhava Nagar, Karnataka, 576104

  • Vanda Investigative Site

    Madurai, Tamil Nadu, 625020

  • Vanda Investigative Site

    Mangalore, Karnataka, 575001

  • Vanda Investigative Site

    Mangalore, Karnataka, 575018

  • Vanda Investigative Site

    Mysore, Karnataka, 570004

  • Vanda Investigative Site

    Nashik, Maharashtra, 422101

  • Vanda Investigative Site

    Pune, Maharashtra, 411030

  • Vanda Investigative Site

    Varanasi, Uttar Pradesh, 221005

Other trials in India

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate Prevention of Relapse in Patients With Schizophrenia Receiving Either Flexible Dose Iloperidone or Placebo in Long-term Use (up to 26 Weeks) Followed by up to 52 Weeks of Open-label Extension

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

Conditions
Schizophrenia
Being tested
Iloperidone, Placebo
Keywords
Schizophrenia, Mental Disorders, Antipsychotic Agents, Iloperidone, Relapse Prevention
Medical subject headings
Schizophrenia, Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IloperidoneDrug

    Also called Fanapt®

    Over-encapsulated iloperidone tablets were administered orally using a bid schedule; the strengths used include 1, 2, 4, 6, 8, 10, and 12 mg.

  • PlaceboDrug

    Matching placebo capsules were administered orally using a bid schedule during the double-blind period.

Study groups in NCT01291511
Study groupRoleWhat they receive
IloperidoneExperimentalAfter 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.
Receives: Drug: Iloperidone
PlaceboPlacebo comparatorPost-randomization matching placebo is administered orally bid during the double-blind period.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to Relapse or Impending Relapse

    Relapse or impending relapse was defined as any of the following: hospitalization due to worsening of schizophrenia; increase (worsening) of the PANSS total score of greater than or equal to 30% from randomization, PANSS total score confirmed at a second visit conducted within 1-7 days; clinically significant emergent or worsening suicidal, homicidal, or aggressive behavior; a CGI-Improvement (CGI-I) score of 6 (much worse) or 7 (very much worse) after randomization; a dose increase in study medication or a need for additional open-label antipsychotic treatment.

    Measured: Up to 26 weeks post-randomization

Secondary outcomes (3)

  1. PANSS Total Score, Change From Baseline to Last Visit

    The 30-item Positive and Negative Syndrome Scale (PANSS) was developed to assess the severity of symptoms of schizophrenia. The PANSS items are divided into positive, negative, and general psychopathology factors. All items were rated on a scale of 1 (absent) to 7 (extremely severe). The PANSS total score (or rating) is the sum of all 30 PANSS items taken together (the sum of its 3 subscales), with a maximum score of 210. Change from baseline is calculated as post value minus baseline value. A negative change indicates improvement.

    Measured: Up to 26 weeks post-randomization

  2. CGI-S, Last Visit

    The 7-item Clinical Global Impression of Severity (CGI-S) scale was developed to assess the overall, absolute degree of illness at any point in time. A rating of 1 is equivalent to "normal, not at all ill," and a rating of 7 is equivalent to "among the most extremely ill patients."

    Measured: Up to 26 weeks post-randomization

  3. SDS Total Score, Change From Baseline to Last Visit

    The Sheehan Disability Scale (SDS) a self-reported measure that was developed to assess functional impairment in 3 inter-related domains (i.e., work/school, social, and family life). It is a 10-point visual analog scale with 0 being not impaired at all and 10 extremely impaired. Change from baseline is calculated as post value minus baseline value. A negative change indicates improvement.

    Measured: Up to 26 weeks post-randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2011 (estimated)
  2. Study startFeb 2011
  3. Primary completionMar 2014
  4. Study completionMar 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
635 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01291511
Sponsor's protocol ID
CILO522D2301
Acronym
REPRIEVE
Status last verified
Jul 2023
First submitted
3 Feb 2011
Last updated
17 Jul 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

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.

    PubMed 27379654

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Iloperidone in people with Schizophrenia, run by Vanda Pharmaceuticals at 63 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 sites in United States, Ukraine, India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Relapse or Impending Relapse (time frame: Up to 26 weeks post-randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01291511, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2023.

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