A clinical trial to study prevention of relapse in patients with schizophrenia receiving either flexible dose iloperidone or placebo in long-term use.
- Conditions
- Health Condition 1: null- Schizophrenia
- Registration Number
- CTRI/2010/091/001409
- Lead Sponsor
- ovartis Healthcare Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 710
Patients will be males or females, 18 through 65 years of age inclusive.
- Patients will have a clear diagnosis of schizophrenia according to DSM-IV criteria for at least 1 year. This includes DSM-IV diagnoses of schizophrenia (i.e., 295) with suffixes 10 (disorganized), 20 (catatonic), 30 (paranoid), 60 (residual), or 90 (undifferentiated).
- Patients will be in need of ongoing psychiatric treatment and must have a documented reason why a change in treatment is warranted, which might reasonably be expected to possibly lead to a clinical improvement. This will be recorded as either:
- Insufficient efficacy (i.e., not fully in remission or experiencing residual symptoms) and / or Tolerability/safety concerns (e.g. weight gain, extrapyramidal symptoms, etc.)
- At the screening visit patients will have a PANSS score of no more than 100 and a CGI of no more than 5 (i.e. must not be severely ill or worse).
- History of at least 2 prior episodes of relapse or impending relapse in the 2 years preceding the screening visit (i.e., verifiable in source documents by report of health professional or patient?s caregiver or relative).
- Patients who meet the DSM-IV criteria for schizophreniform disorder (295.40) and schizoaffective (295.70) will be excluded.
- 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 positive urine drug screen (at the screening visit) for amphetamines, cocaine, phencyclidine (PCP), or opiates will be excluded. If opiates are positive at screening and clearly due to the use of pain killing medication, the patient may be rescreened after the medication has been discontinued and enrolled in the study if urine drug screen is negative.
- Otherwise patients positive for opiates will be disqualified from any future participation in the study.
- Patients who have been hospitalized due to suicidal ideation or suicidal behavior; or patients considered to have serious suicidal ideation or suicidal behavior within the 6 months prior to the screening visit; or patients having active suicidal ideation or behavior at the screening visit as determined by the Columbia Suicide-Severity Rating Scale (C-SSRS).
- Patients currently having clinically significant neurological, metabolic (including type 1 diabetes), hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, and/or urological disorder such as unstable angina, congestive heart failure (uncontrolled), or central nervous system (CNS) infection, that would pose a risk to the patient if they were to participate in the study or that might confound the results of the study. Patients with known human immunodeficiency virus (HIV) seropositivity. However, unless clinically indicated, HIV testing will not be performed.
- Treatment naïve, first episode patients.
- Patients taking iloperidone at the screening visit.
- Patients with known hypersensitivity to drugs chemically related to benzisoxazoles.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method