EFFICIENCY OF LONG ACTING OLANZAPINE INJECTION IN SCHIZOPHRENIA

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2017/05/008586
• Date of registration: 17-05-2017
• Prospective Registration: Yes
• Primary sponsor: Dr Varun S Mehta
• Public title: EFFICIENCY OF LONG ACTING OLANZAPINE INJECTION IN SCHIZOPHRENIA
• Scientific title: TOLERABILITY AND EFFICACY OF OLANZAPINE LONG ACTING INJECTION IN SCHIZOPHRENIA â??A RANDOMIZED HOSPITAL BASED STUDY
• Date of first enrolment: 01-06-2017
• Target sample size: 40
• Recruitment status: Not Yet Recruiting
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=18722
• Study type: Interventional
• Study design: Randomized, Parallel Group Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
• Phase: N/A

Countries of recruitment

India

Contacts

• Name: Dr Varun S Mehta
• Affiliation: Central Institute of Psychiatry

• Name: Dr Varun S Mehta
• Affiliation: Central Institute of Psychiatry

Key inclusion & exclusion 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: 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

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Diagnosed with schizophrenia

Intervention(s)

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: NOT APPLICABLE: NOT APPLICABLE

Primary Outcome(s)

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 Outcome(s)

NOT APPLICABLETimepoint: NOT APPLICABLE

Secondary ID(s)

NIL

Source(s) of Monetary Support

Central Institute of Psychiatry, Kanke, Ranchi, Jharkhand - 834006.

Ethics review

Status: Approved
Approval date: 10/11/2016
Contact:

Ethics Committee, Central Institute of Psychiatry