Summary
Celecoxib has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Schizophrenia would be drug repurposing rather than first-in-human development. This does not mean it is approved for Schizophrenia. ClinicalTrials.gov lists 3 registered trials linking Celecoxib to Schizophrenia: 2 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT04020588). The largest enrolment is 270 participants (NCT00639483). Registration activity spans 2003 to 2019. The literature layer holds 13 publications for this pair: 5 Cochrane reviews, 2 meta-analyses, 1 systematic review and 5 clinical trial publications. Publication years run from 2007 to 2026. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Schizophrenia ranks 499 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Spontaneous full remission rare (<10%); after first episode, ~80% relapse within 5 years without maintenance antipsychotic; functional disability accumulates over time; 20% achieve good long-term outcome.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 59.0 (trials 9.0, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 3 total: 0 recruiting, 0 active / not yet recruiting, 2 completed, 1 other |
| Linked publications | 13 (5 Cochrane reviews, 5 clinical trial publications, 2 meta-analyses, 1 systematic review) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | DGIdb |
| Linked via biomarker / target | ATP2A2 |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT04020588 | Anti-inflammatories and Adolescent Schizophrenia 2019 | status unknown | Phase 4 | 90 |
| NCT00639483 | Efficacy and Safety of Celecoxib as Add-on Therapy to Risperidone Versus Risperidone Alone in Patients With Schizophrenia 2003 | completed | Phase 2 | 270 |
| NCT00686140 | A Double-blind and Randomized Trial of Celecoxib Added to Risperidone in Treatment-naive First-episode Schizophrenia 2006 | completed | Not applicable | 200 |
Published literature
- Meta-analysis Efficacy and safety of anti-inflammatory drug-assisted treatment of symptoms in patients with schizophrenia: a meta-analysisLi H, Shen H, Duan X et al. · BMC psychiatry · 2026 · PMID 41559638
- Cochrane review Efficacy and safety of celecoxib in schizophrenia: a systematic review and meta-analysis of randomized controlled trialsFarag N, Selim A, Hassan O et al. · Inflammopharmacology · 2025 · PMID 40833536
- Clinical trial publication A double-blind, randomized controlled study of the effects of celecoxib on clinical symptoms and cognitive impairment in patients with drug-naïve first episode schizophrenia: pharmacogenetic impact of cyclooxygenase-2 functional polymorphismsWang DM, Chen DC, Xiu MH et al. · Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2024 · PMID 37903861
- Cochrane review TLR/mTOR inflammatory signaling pathway: novel insight for the treatment of schizophreniaLashgari NA, Roudsari NM, Shamsnia HS et al. · Canadian journal of physiology and pharmacology · 2024 · PMID 37955633
- Cochrane review Anti-inflammatory medications for the treatment of mental disorders: A scoping reviewFitton R, Sweetman J, Heseltine-Carp W et al. · Brain, behavior, & immunity - health · 2022 · PMID 36217374
- Clinical trial publication Associations between expression of indoleamine 2, 3-dioxygenase enzyme and inflammatory cytokines in patients with first-episode drug-naive SchizophreniaZhang Y, Shi H, Yang G et al. · Translational psychiatry · 2021 · PMID 34802039
- Clinical trial publication Simvastatin Augmentation for Patients With Early-Phase Schizophrenia-Spectrum Disorders: A Double-Blind, Randomized Placebo-Controlled TrialSommer IE, Gangadin SS, de Witte LD et al. · Schizophrenia bulletin · 2021 · PMID 33608711
- Cochrane review An update on the efficacy of anti-inflammatory agents for patients with schizophrenia: a meta-analysisÇakici N, van Beveren NJM, Judge-Hundal G et al. · Psychological medicine · 2019 · PMID 31439071
- Cochrane review Adjunctive use of anti-inflammatory drugs for schizophrenia: A meta-analytic investigation of randomized controlled trialsCho M, Lee TY, Kwak YB et al. · The Australian and New Zealand journal of psychiatry · 2019 · PMID 30864461
- Meta-analysis Meta-analysis of genomic variants and gene expression data in schizophrenia suggests the potential need for adjunctive therapeutic interventions for neuropsychiatric disordersAnirudh Chellappa S, Pathak AK, Sinha P et al. · Journal of genetics · 2019 · PMID 31204709
- Systematic review Effectiveness and tolerance of anti-inflammatory drugs' add-on therapy in major mental disorders: a systematic qualitative reviewFond G, Hamdani N, Kapczinski F et al. · Acta psychiatrica Scandinavica · 2014 · PMID 24215721
- Clinical trial publication Celecoxib treatment in an early stage of schizophrenia: results of a randomized, double-blind, placebo-controlled trial of celecoxib augmentation of amisulpride treatmentMüller N, Krause D, Dehning S et al. · Schizophrenia research · 2010 · PMID 20570110
- Clinical trial publication Celecoxib as adjunctive therapy in schizophrenia: a double-blind, randomized and placebo-controlled trialAkhondzadeh S, Tabatabaee M, Amini H et al. · Schizophrenia research · 2007 · PMID 17208413
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target ATP2A2. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Celecoxib approved for Schizophrenia?
Celecoxib has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Schizophrenia would be drug repurposing rather than first-in-human development. This does not mean it is approved for Schizophrenia. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Celecoxib in clinical trials for Schizophrenia?
ClinicalTrials.gov lists 3 registered trials linking Celecoxib to Schizophrenia: 2 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT04020588). The largest enrolment is 270 participants (NCT00639483). Registration activity spans 2003 to 2019.
What does the evidence show for Celecoxib in Schizophrenia?
Celecoxib has both completed registered trials and synthesis-level publications linked to Schizophrenia. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target ATP2A2. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.