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Use of Celecoxib (a pain-relief and anti-inflammatory medicine) along with standard treatment in patients with first-episode schizophrenia: A study on its effect on symptoms and body chemicals related to inflammation

Celecoxib augmentation in patients with first episode schizophrenia and its correlation with Indoleamine 2,3-dioxygenase, Interferon-gamma, and Tumor Necrosis Factor-alpha: An open label case control study - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/093611
Enrollment
75
Registered
2025-08-25
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F20- Schizophrenia

Interventions

Intervention1: Celecoxib Augmentation: Tablet Celecoxib 400mg/day orally for 6 weeks in first episode of schizophrenia along with Antipsychotics Control Intervention1: NIL: NIL

Sponsors

Central Institute Of Psychiatry
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Inpatients satisfying the Clinical Description and Diagnostic Requirements [CDDR 2022] for ICD 11 criteria of Schizophrenia, first episode, currently symptomatic. 2.Drug naive patients or drug free for minimum 2 weeks on antipsychotics and 4 weeks for depot antipsychotics. 3.Duration of illness is less than 1 year. 4.Age group of 18-50 years of both sexes. 5.CDSS score less than 6 to rule out secondary negative symptoms. 6.Those who give informed consent for participating in the study.

Exclusion criteria

Exclusion criteria: 1.Any other major co-morbid psychiatric diagnosis and substance dependence excluding nicotine & caffeine. 2.Significant medical or neurological illness including severe cardiovascular, hepatic, renal [serum creatinine > 1.5 mg/dl], anaemia [Haemoglobin 3.Pregnancy 4.Known hypersensitivity to Capsule Celecoxib or any of its components 5.Any current systemic infection/ inflammation 6.Not willing to give written informed consent

Design outcomes

Primary

MeasureTime frame
1.To study the effectiveness of Cap. Celecoxib (400 mg/day) an augmentative therapy in patients with first episode schizophrenia by comparing PANSS, MOCA & CGI-SCH scores at baseline & 3 weeks & 6 weeks.Timepoint: Baseline 3 weeks 6 weeks

Secondary

MeasureTime frame
1.To study the effect of Cap. Celecoxib (400 mg/day) on the levels of Indoleamine 2,3dioxygenase, Interferon gamma, & Tumor Necrosis Factor-alpha at 3 weeks & 6 weeks. 2.To compare the levels of Indoleamine 2,3 dioxygenase, Interferon gamma & Tumor Necrosis Factor alpha between patients with first episode schizophrenia & healthy controls Timepoint: Baseline 3 weeks 6 weeks

Countries

India

Contacts

Public ContactDr Surendra Paliwal

Central Institute Of Psychiatry

itsme.paliwal@gmail.com8005940887

Outcome results

None listed

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