CTRI/2017/05/008611CompletedPhase 3
A Randomized Double Blind Placebo Controlled Study Of Celecoxib Add-On Therapy In Schizophrenia
King Georges Medical University0 sites50 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 50
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility 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
- •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.
Investigators
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