Summary
Methotrimeprazine 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lists 3 registered trials linking Methotrimeprazine to Schizophrenia: 2 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT02374567). The largest enrolment is 725489 participants (NCT02582736). Registration activity spans 2011 to 2015. The literature layer holds 3 publications for this pair: 1 Cochrane review, 1 systematic review and 1 clinical trial publication. Publication years run from 1996 to 2023. 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 | 37.5 (trials 7.5, literature 10.0, tier 15, approved bonus 5.0) |
| Registered trials | 3 total: 0 recruiting, 0 active / not yet recruiting, 2 completed, 1 other |
| Linked publications | 3 (1 Cochrane review, 1 systematic review, 1 clinical trial publication) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | DGIdb |
| Linked via biomarker / target | ADRA1B |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT02374567 | Pharmacovigilance in Gerontopsychiatric Patients 2015 | terminated | Phase 3 | 407 |
| NCT03019887 | Correlation Between Cognitive Function and Relapse of Schizophrenia Regarding Dose Reduction 2011 | completed | Not applicable | 139 |
| NCT02582736 | Antipsychotics and Risk of Hyperglycemic Emergencies 2012 | completed | Not applicable | 725,489 |
Published literature
- Systematic review The role of phenothiazine derivatives in autophagy regulation: A systematic reviewOtręba M, Stojko J, Rzepecka-Stojko A · Journal of applied toxicology : JAT · 2023 · PMID 36165981
- Cochrane review Systematic review of antipsychotics for the treatment of hospital-associated delirium in medically or surgically ill patientsLacasse H, Perreault MM, Williamson DR · The Annals of pharmacotherapy · 2006 · PMID 17047137
- Clinical trial publication Antipsychotic and anxiolytic properties of risperidone, haloperidol, and methotrimeprazine in schizophrenic patientsBlin O, Azorin JM, Bouhours P · Journal of clinical psychopharmacology · 1996 · PMID 8834417
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 ADRA1B. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Methotrimeprazine approved for Schizophrenia?
Methotrimeprazine 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 Methotrimeprazine in clinical trials for Schizophrenia?
ClinicalTrials.gov lists 3 registered trials linking Methotrimeprazine to Schizophrenia: 2 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT02374567). The largest enrolment is 725489 participants (NCT02582736). Registration activity spans 2011 to 2015.
What does the evidence show for Methotrimeprazine in Schizophrenia?
Methotrimeprazine 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 ADRA1B. 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.