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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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CTRI |
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Last refreshed on:
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24 November 2021 |
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Main ID: |
CTRI/2014/07/004740 |
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Date of registration:
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15-07-2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effectiveness of ranitidine in weight gain caused by olanzapine in patients with schizophrenia
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Scientific title:
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Efficacy of Ranitidine in Olanzapine induced weight gain: A dose response study |
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Date of first enrolment:
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24-06-2010 |
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Target sample size:
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75 |
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Recruitment status: |
Completed |
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URL:
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=7044 |
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Study type:
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Interventional |
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Study design:
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Randomized, Parallel Group Trial
Method of generating randomization sequence:Random Number Table Method of allocation concealment:Not Applicable Blinding and masking:Open Label
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Phase:
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N/A
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Countries of recruitment
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India
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Contacts
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Name:
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Dr D Ram
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Address:
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Central Institute of Psychiatry, Kanke, Ranchi
834006
Ranchi, JHARKHAND
India |
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Telephone:
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7856866667 |
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Email:
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dram_cip@rediffmail.com |
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Affiliation:
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Professor of Psychiatry |
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Name:
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Varun S Mehta
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Address:
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Central Institute of Psychiatry, Kanke
834006
Ranchi, JHARKHAND
India |
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Telephone:
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7856866667 |
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Email:
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dram_cip@rediffmail.com |
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Affiliation:
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Professor of Psychiatry |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Subjects satisfying the ICD 10 criteria for schizophrenia admitted in institute as their first episode.
2. Drug free patients for minimum 4weeks on oral antipsychotics and 8 weeks on depot preparation.
3. Those giving written informed consent for study
Exclusion criteria: 1. Any other major comorbid psychiatric diagnosis and substance dependence excluding nicotine and caffeine.
2. Presence of significant medical or neurological illness.
3. BMI > 30kg/m2
4. Not ready for consent
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Health Condition 1: null- Schizophrenia
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Intervention(s)
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Intervention1: Ranitidine: Ranitidine was administered at a fixed dose of 150 mg/day along with olanzapine for a duration of 8 weeks
Intervention2: Ranitidine: Ranitidine was administered at a fixed dose of 300 mg/day along with olanzapine for a duration of 8 weeks
Control Intervention1: Olanzapine: Olanzapine was continued as per clinical response for a duration of 8 weeks
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Primary Outcome(s)
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Change in weight after receiving ranitidineTimepoint: Baseline, 4 and 8 weeks
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Secondary Outcome(s)
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Complete Haemogram, Liver function tests, renal function tests, lipid profile, fasting and postprandial blood sugar, PANSS scoresTimepoint: baseline, 4 and 8 weeks.
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Source(s) of Monetary Support
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Nil
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Ethics review
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Status: Approved
Approval date: 24/05/2010
Contact:
Institutional Ethics Committee, C.I.P., Ranchi
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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