Study of Effects of Celecoxib Augmentation of Olanzapine Treatment In Schizophrenia in a Randomized Controlled Trial
- Conditions
- Health Condition 1: null- SCHIZOPHRENIA
- Registration Number
- CTRI/2017/05/008611
- Lead Sponsor
- King Georges Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
1.Diagnosis of Schizophrenia as per ICD-10, DCR (Diagnostic Criteria for reasearch)
2.Patients aged between 18 to 50 years
3.Not on any antipsychotic for last three months.
4.Total duration of illness less than ten years.
5.Availability of a reliable informant
6.Written informed consent from the patient and/or informant.
1.Positive and Negative Syndrome Scale (PANSS) score <80 or >120.
2.Presence of any other major psychiatric disorder, except nicotine dependence.
3.Patients with pre-existing mental subnormality
4.Patients at risk for harm to self or others.
5.Established treatment resistance for schizophrenia.
6.Clinical situations requiring alternative drugs or interventions eg injectable antipsychotics, ECTs, change of therapy etc., or worsening of symptoms.
7.Patients having history of ischemic heart disease/ hypertension/ liver disease/ cardiac failure/ cerebrovascular disease/ immunological disorders/ obesity/ diabetes or any other disease that may alter serum interleukin levels.
8.Any clinically significant abnormality in routine investigations, ( Hb, TLC, DLC, RBS, S.Urea, S.Creatinine, LFT)
9.Patient on any other concomitant drugs that might alter serum interleukin levels.
10.Pregnant and lactating females.
11.Patients developing any illness during the course of study that might change the serum interleukin levels.
12.Withdrawal of consent.
13.Safety concerns.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method improvement in the positive, negative and cognitive symptoms of schizophrenia as measured on Positive and Negative Symptom Scale (PANSS) and Schizophrenia Cognition Rating Scale (SCoRS)Timepoint: 8 weeks
- Secondary Outcome Measures
Name Time Method to measure the change in serum interleukin 1B and serum interleukin 6 levels at the end of treatment as compared to that at baselineTimepoint: 8 weeks