A clinical trial to study the effect of Olanzapine Long Acting Injection with Oral Olanzapine in Patients with Schizophrenia

Phase 3

• Conditions: Health Condition 1: null- Schizophrenia

• Registration Number: CTRI/2012/04/002552
• Lead Sponsor: Torrent Pharmaceuticals LtdTorrent Research CentreVillage BhatDist Gandhinagar Gujarat

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 200

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified