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EFFICIENCY OF LONG ACTING OLANZAPINE INJECTION IN SCHIZOPHRENIA

TOLERABILITY AND EFFICACY OF OLANZAPINE LONG ACTING INJECTION IN SCHIZOPHRENIA â??A RANDOMIZED HOSPITAL BASED STUDY

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/05/008586
Enrollment
40
Registered
2017-05-17
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Diagnosed with schizophrenia

Interventions

Intervention1: Long Acting (Depot) Olanzapine Pamoate Injection (300mg): The depot will be given at a dose of 300mg every 15 days till 06 weeks after receiving the first dose Control Intervention1: NO

Sponsors

Dr Varun S Mehta
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Diagnosis of Schizophrenia according to Diagnostic Criteria for Research of International Classification of Diseases -tenth edition (ICD-10) 2. Documented reduction of 50 % from the baseline score in PANSS & BPRS within 4 weeks of treatment with oral olanzapine 3. Patients with illness duration of >2 years 4. Patients who had at least one relapse in previous one year due to non-adherence 5. Patients who are anti-psychotic drug-free for last 4 weeks (oral) or 8 weeks (depot preparation) 6. Patients who give written informed consent.

Exclusion criteria

Exclusion criteria: 1. Past history of documented non-response to Olanzapine 2. Past history of use of olanzapine Long-Acting Injection 3. History of significant head injury or epilepsy 4.Any comorbid psychiatric illness or substance use in dependence pattern except nicotine or caffeine 5.Known case of Hypertension, Diabetes mellitus or Dyslipidemia 6. Body mass index greater than or equal to 30 kg/m2 7.Not willing to give consent

Design outcomes

Primary

MeasureTime frame
1. Change in the scores of the Positive and Negative Symptom Scale (PANSS) 2. Changes in the scores of Brief Psychiatric Rating Scale (BPRS) 3. Chnage in the Clinical Global Impression Scale (CGI) 4. Change in the clinical parameters of Blood Pressure, Body Mass Index (BMI) and Waist Circumference 4.Change in the laboratory parameters namely Fasting Glucose, Serum Triglycerides and HDL - CTimepoint: 1. The clinical rating scales (PANSS,BPRS,CGI) will be applied at baseline and weekly till 6 weeks 2. The clinical and laboratory parameters will be measured at baseline and then at the end of six weeks—

Secondary

MeasureTime frame
NOT APPLICABLETimepoint: NOT APPLICABLE—

Countries

India

Contacts

Public ContactDr Varun S Mehta

Central Institute of Psychiatry

vs_mehta@yahoo.co.in

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026