Relapse Prevention Study in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Recurrence; Schizophrenia
Intervention: Iloperidone; Placebo
Intervention description: Over-encapsulated iloperidone tablets were administered orally using a bid schedule; the strengths used include 1, 2, 4, 6, 8, 10, and 12 mg.; Matching placebo capsules were administered orally using a bid schedule during the double-blind period.
Intervention MeSH terms: Iloperidone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 635.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Schizophrenia; Mental Disorders; Antipsychotic Agents; Iloperidone; Relapse Prevention

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

Eligibility 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