Health Condition 1: null- Schizophrenia
Conditions
Interventions
Intervention1: Olanzapine Long Acting Injection: Dose: 405mg/4 weeks
Duration: Treatment duration with Olanzapine Long Acting injection - 8 weeks
Mode of Administration: Olanzapine long acting injec
Duration: Treatment duration with Olanzapine Long Acting injection - 8 weeks
Mode of Administration: Olanzapine long acting injection 210mg/vial by deep intra muscular injection in the gluteal region. Frequency of dose: 210mg/2 weeks
Intervention3: Olanzapine Long Acting Injec
Mode of Administration: Olanzapine long acting injection: 300mg/vial by deep intra muscular injection in the gluteal region. Frequency of dose: 300mg/2 weeks
Intervention4: Olanzapine Tablets: Dose: 1
Duration: For patients randomized to oral olanzapine: 8 weeks Mode of administration: The patients randomised to oral olanzapine will be advised to take the medications orally, swallowed as a whole wi
Mode of Administration: Olanzapine long acting injection 210mg/vial by deep intra muscular injection in the gluteal region. Frequency of dose: 210mg/2 weeks
Intervention6: Olanzapine Long Acting Injec
Mode of Administration: Olanzapine long acting injection: 300mg/vial by deep intra muscular injection in th
Sponsors
Torrent Pharmaceuticals LtdTorrent Research CentreVillage BhatDist Gandhinagar Gujarat
Eligibility
Inclusion criteria
Inclusion criteria: Patients (male or female) aged between 18-65 years (inclusive both) Patients with diagnosis of schizophrenia as per DSM-IV and PANSS score >= 70 for schizophrenia Patients receiving treatment of >=10mg/day oral olanzapine for at least 2 weeks Patients receiving treatment with an injectable long acting antipsychotics must have received the last injection at least 2 weeks or one injection interval, whichever is longer, prior to screening visit or the lead in and conversion period (Study period I). Patients taking risperidone long-acting injections must have received their last injection at least 4 weeks prior to screening visit or the lead in and conversion period (Study period I). Informed consent given by patient or his/her legally acceptable representative
Exclusion criteria
Exclusion criteria: Patients with DSM-IV axis I diagnosis other than schizophrenia, If they had DSM-IV axis I diagnosis of substance dependence (except nicotine or caffeine) within 3 months before screening. Pregnant, nursing women or women planning for pregnancy Patient having a history of violence or recent (3 months) history of suicidal attempts or suicidal ideation. Patients previously experienced clinical significant adverse events during treatment with oral olanzapine Patient with dementia related psychosis Patient with a medical condition that is serious and/or acutely unstable in the past three months. Patient with substance or alcohol abuse disorder. Patients with liver enzymes (ALT and AST) more than 2.5X the normal value and/or bilirubin more than 1.5X the normal value Participation in any clinical trial within the past 30 days. Electroconvulsive treatment within 3 months before screening and /or had involuntary admission to psychiatric hospital. History of Tardive Dyskinesia or Neuroleptic Malignant Syndrome Male patients with diagnosis of enlarged prostate Patients with diagnosis of bowel obstruction Patients with diagnosis of narrow angle glaucoma Patient with evidence of allergic reactions on usage of the proposed study drugs and method of administration. Patient with a diagnosis of diabetes mellitus Patient with serum creatinine more than upper limit of normal value. History of significant orthostatic hypotension (i.e., a drop in systolic blood pressure of 30 mm Hg or more and/or a drop in diastolic blood pressure of 20 mm Hg or more on standing)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in PANSS total score from baseline (week 4) to end of the trial(week 12).Timepoint: Baseline - Week 4, End of the trial - Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Global Impression-Severity (CGI-S) and CGI-Improvement (CGI-I).Timepoint: Baseline: Week 4 End of Trial: Week 12;Clinical laboratory evaluations: change in blood glucose and lipid parameterTimepoint: Baseline:4 weeks End of trial:12 weeks;Evaluation of Exacerbation symptomsTimepoint: Baseline: 4 weeks End of trial: 12 weeks;Extrapyramidal symptoms will be evaluated by following scales at each visit 3 and at end of trial visit: â?¢ Abnormal involuntary movement scale (AIMS) â?¢ Barnes Akathesia Rating Scale (BARS) â?¢ Simpson-Angus scale (SAS)Timepoint: Baseline: Week 4 (visit 3) End of trial: Week 12;For patients on treatment-A, after each injection, patients will be kept under observations for at least 3 hours to record Post-Injection Delirium/Sedation Syndrome (PDSS) and injection site AEs.Timepoint: After administration of injection, during the trial duration;Mean baseline to end point change in the score of PANSS positive and Negative subscale and BPRS score.Timepoint: Baseline: Week 4 End of Trial: Week 12;Treatment emergent adverse event (TEAEs) using MedDRA terminology preferred terms.Timepoint: Treamtment emergent advese event occurring throughtout the trial duration will be recorded. | — |
Countries
India
Contacts
Public ContactMs Sweety Shah
Torrent Pharmaceuticals Ltd., India
Outcome results
None listed