Health Condition 1: null- Schizophrenia
Conditions
Interventions
Intervention1: Ilperidone: 8-24 mg, bid. 26 weeks
Control Intervention1: Placebo: bid. 26 weeks
Sponsors
Novartis Healthcare Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: - 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).
Exclusion criteria
Exclusion criteria: - 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.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| - Adverse events (AEs); - Clinical laboratory tests (hematology, blood chemistry, and urinalysis) and serum prolactin; - Vital signs (heart rate, pulse, blood pressure, waist circumference); - Body weight; - physical examinations; - 12-lead electrocardiograms (ECG); - Columbia Suicide-Severity Rating Scale (C-SSRS), and movement disorder rating scales (Simpson Angus Scale, Barnes Akathisia Rating Scale and - Abnormal Involuntary Movement Scale).Timepoint: During conduct of study | — |
Primary
| Measure | Time frame |
|---|---|
| - time to relapse or impending relapse; - PANSS; - Brief Psychiatric Rating Scale (BPRS); - CGI-S scale; - Clinical Global Impression of Improvement (CGI-I) scale; and - Sheehan Disability Scale (SDS).Timepoint: During conduct of study | — |
Countries
India
Contacts
Public ContactSuchela Srivatsa
Quintiles Research (India) Private Limited
Outcome results
None listed