Study of Effects of Celecoxib Augmentation of Olanzapine Treatment In Schizophrenia in a Randomized Controlled Trial

A Randomized Double Blind Placebo Controlled Study Of Celecoxib Add-On Therapy In Schizophrenia

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/05/008611

Enrollment

Registered

2017-05-22

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- SCHIZOPHRENIA

Interventions

Intervention1: olanzapine (5- 30 mg/day) individed doses,celecoxib 200mg BD for 8 weeks: olanzapine will be given in doses ranging from 5-30 mg for durations as per standard treatment guidelines along

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 1.Positive and Negative Syndrome Scale (PANSS) score 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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

India

Contacts

Public ContactKabir Garg

King Georges Medical University

an.kgmu@gmail.com9935719000

Outcome results

None listed

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