Loading clinical trials...

Relapse Prevention Study in Patients With Schizophrenia | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Relapse Prevention Study in Patients With Schizophrenia

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

NCT01291511•Vanda Pharmaceuticals

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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.
+6 more criteria

Locations (63)

Vanda Investigative Site

Anaheim, California, United States

Vanda Investigative Site

Bellflower, California, United States

Vanda Investigative Site

Costa Mesa, California, United States

Vanda Investigative Site

Escondido, California, United States

Vanda Investigative Site

La Habra, California, United States

Vanda Investigative Site

Oceanside, California, United States

Vanda Investigative Site

Orange, California, United States

Vanda Investigative Site

Pico Rivera, California, United States

Vanda Investigative Site

Riverside, California, United States

Vanda Investigative Site

San Diego, California, United States

Key Dates

Start Date

February 1, 2011

Primary Completion Date

March 1, 2014

Completion Date

March 1, 2015

Last Updated

July 17, 2023

Enrollment

635

ACTUAL participants

Conditions

Schizophrenia

Interventions

Iloperidone

DRUG

Placebo

DRUG

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

NCT07455929

Psychotic DisordersSchizophrenia Spectrum Disorders

View study

RECRUITING

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

NCT06740383

Schizophrenia Spectrum and Other Psychotic DisordersSchizophrenia+5 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 17, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Relapse Prevention Study in Patients With Schizophrenia

Inclusion Criteria

Exclusion Criteria

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

A Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Inpatient Adults With Schizophrenia

Acceptability, Feasibility and Preliminary Outcomes of the Kiso Mind App for Outpatients With Schizophrenia Spectrum Disorders

Brain Stimulation to the Hippocampus in Schizophrenia

Develop a Novel Occupational Training Program for Schizophrenia Patients Based on Virtual Reality Techniques