Relapse Prevention Study in Patients With Schizophrenia

NCT01291511 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: CILO522D2301
• Study Type: interventional
• Target: 635
• Locations: 3 countries
• Sites: 63

Brief Summary

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

Conditions

Schizophrenia

Keywords

Schizophrenia; Mental Disorders; Antipsychotic Agents; Iloperidone; Relapse Prevention

Outcome Measures

Primary Outcomes (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.

  Up to 26 weeks post-randomization

Secondary Outcomes (3)

• PANSS Total Score, Change From Baseline to Last Visit

  Up to 26 weeks post-randomization

• CGI-S, Last Visit

  Up to 26 weeks post-randomization

• SDS Total Score, Change From Baseline to Last Visit

  Up to 26 weeks post-randomization

Study Arms (2)

Iloperidone

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Post-randomization matching placebo is administered orally bid during the double-blind period.

Drug: Placebo

Interventions

Iloperidone DRUG

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

Also known as: Fanapt®

Iloperidone

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanda Pharmaceuticals: lead

Study Sites (63)

Vanda Investigative Site

Anaheim, California, 92604, United States

Location

Vanda Investigative Site

Bellflower, California, 92706, United States

Location

Vanda Investigative Site

Costa Mesa, California, 92626, United States

Location

Vanda Investigative Site

Escondido, California, 92025, United States

Location

Vanda Investigative Site

La Habra, California, 90631, United States

Location

Vanda Investigative Site

Oceanside, California, 92056, United States

Location

Vanda Investigative Site

Orange, California, 92868, United States

Location

Vanda Investigative Site

Pico Rivera, California, 90660, United States

Location

Vanda Investigative Site

Riverside, California, 92506, United States

Location

Vanda Investigative Site

San Diego, California, 92102, United States

Location

Vanda Investigative Site

San Diego, California, 92103, United States

Location

Vanda Investigative Site

San Diego, California, 92121, United States

Location

Vanda Investigative Site

Santa Ana, California, 92705, United States

Location

Vanda Investigative Site

Melbourne, Florida, 32901, United States

Location

Vanda Investigative Site

Miami, Florida, 33126, United States

Location

Vanda Investigative Site

Oakland Park, Florida, 33334, United States

Location

Vanda Investigative Site

Atlanta, Georgia, 30308, United States

Location

Vanda Investigative Site

Atlanta, Georgia, 30328, United States

Location

Vanda Investigative Site

St Louis, Missouri, 63109, United States

Location

Vanda Investigative Site

Nashua, New Hampshire, 03060, United States

Location

Vanda Investigative Site

Marlton, New Jersey, 08053, United States

Location

Vanda Investigative Site

Brooklyn, New York, 11235, United States

Location

Vanda Investigative Site

Staten Island, New York, 10312, United States

Location

Vanda Investigative Site

Hickory, North Carolina, 28601, United States

Location

Vanda Investigative Site

Beachwood, Ohio, 44122, United States

Location

Vanda Investigative Site

Philadelphia, Pennsylvania, 19139, United States

Location

Vanda Investigative Site

Irving, Texas, 75062, United States

Location

Vanda Investigative Site

Salt Lake City, Utah, 84106, United States

Location

Vanda Investigative Site

Ahmedabad, Gujarat, 380013, India

Location

Vanda Investigative Site

Madhava Nagar, Karnataka, 576104, India

Location

Vanda Investigative Site

Mangalore, Karnataka, 575001, India

Location

Vanda Investigative Site

Mangalore, Karnataka, 575018, India

Location

Vanda Investigative Site

Mysore, Karnataka, 570004, India

Location

Vanda Investigative Site

Nashik, Maharashtra, 422101, India

Location

Vanda Investigative Site

Pune, Maharashtra, 411030, India

Location

Vanda Investigative Site

Jaipur, Rajasthan, 302021, India

Location

Vanda Investigative Site

Madurai, Tamil Nadu, 625020, India

Location

Vanda Investigative Site

Kanpur, Uttar Pradesh, 208005, India

Location

Vanda Investigative Site

Lucknow, Uttar Pradesh, 226003, India

Location

Vanda Investigative Site

Lucknow, Uttar Pradesh, 226006, India

Location

Vanda Investigative Site

Varanasi, Uttar Pradesh, 221005, India

Location

Vanda Investigative Site

Kerch, AR Crimea, 98310, Ukraine

Location

Vanda Investigative Site

Yevpatoria, AR Crimea, 97416, Ukraine

Location

Vanda Investigative Site

Chernihiv, 14000, Ukraine

Location

Vanda Investigative Site

Dnipropetrovsk, 49005, Ukraine

Location

Vanda Investigative Site

Dnipropetrovsk, 49115, Ukraine

Location

Vanda Investigative Site

Donetsk, 83008, Ukraine

Location

Vanda Investigative Site

Donetsk, 83037, Ukraine

Location

Vanda Investigative Site

Ivano-Frankivsk, 76014, Ukraine

Location

Vanda Investigative Site

Kharkiv, 61068, Ukraine

Location

Vanda Investigive Site

Kharkiv, 68061, Ukraine

Location

Vanda Investigative Site

Kyiv, 01030, Ukraine

Location

Vanda Investigative Site

Kyiv, 02660, Ukraine

Location

Vanda Investigative Site

Kyiv, 04080, Ukraine

Location

Vanda Investigative Site

Kyiv, 08631, Ukraine

Location

Vanda Investigative Site

Luhansk, 91045, Ukraine

Location

Vanda Investigative Site

Odesa, 65014, Ukraine

Location

Vanda Investigative Site

Poltava, 36006, Ukraine

Location

Vanda Investigative Site

Simferopol, 95006, Ukraine

Location

Vanda Investigative Site

Stepanovka, 73488, Ukraine

Location

Vanda Investigative Site

Ternopil, 46020, Ukraine

Location

Vanda Investigative Site

Uzhhorod, 88000, Ukraine

Location

Vanda Investigative Site

Vinnytsia, 21005, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 27379654 RESULT

MeSH Terms

Conditions

Schizophrenia; Mental Disorders

Interventions

iloperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders

Limitations and Caveats

The primary limitation of the study design is that the length of the placebo-controlled phase of the study lasted for only 6 months. However, ethical considerations around the use of placebo in this patient population necessarily informed the study design. While the flexible-dosing regimen in this study allowed for a more real-world experience, it also prevented the assessment of dose-response.

Results Point of Contact

• Title: Vanda Pharmaceuticals
• Organization: Vanda Pharmaceuticals

clinicaltrials@vandapharma.com

202-734-3400

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2011
• First Posted: February 8, 2011
• Study Start: February 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2015
• Last Updated: July 17, 2023
• Results First Posted: July 17, 2023

Record last verified: 2023-07

Locations

US (28); IN (13); UA (22)