Disease × agent evidence record

Mirtazapine for Major Depressive Disorder: evidence, trials and status

Mirtazapine has both completed registered trials and synthesis-level publications linked to Major Depressive Disorder. 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.

8 registered trials 1 recruiting 14 publications Evidence tier A · Strong Score 75.0
Research Tracker › Pairs › Major Depressive Disorder › Mirtazapine
Research map, not treatment advice. This page aggregates registry and literature records. It does not evaluate efficacy, dosing or safety for any individual. Discuss any treatment decision with a qualified clinician.

Summary

Mirtazapine has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Major Depressive Disorder would be drug repurposing rather than first-in-human development. This does not mean it is approved for Major Depressive Disorder. ClinicalTrials.gov lists 8 registered trials linking Mirtazapine to Major Depressive Disorder: 1 is currently recruiting; 4 have completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00021528). It plans or enrolled 4000 participants. Registration activity spans 2001 to 2024. The literature layer holds 14 publications for this pair: 5 Cochrane reviews, 3 meta-analyses, 1 systematic review and 5 clinical trial publications. Publication years run from 2023 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 Major Depressive Disorder ranks 580 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: Relapse in 19-45% within 1 year of antidepressant discontinuation after remission; relapse risk ratio (off-medication vs on) falls from 3.69x at 2 months to 1.34x at 5 years.

Open in Repurposing ExplorerMajor Depressive Disorder hubMajor Depressive Disorder biomarkers & interventionsChEMBLOpen Targets

Evidence table

Evidence tierA · Strong
Evidence score75.0 (trials 25.0, literature 30.0, tier 15, approved bonus 5.0)
Registered trials8 total: 1 recruiting, 0 active / not yet recruiting, 4 completed, 3 other
Linked publications14 (5 Cochrane reviews, 5 clinical trial publications, 3 meta-analyses, 1 systematic review)
Agent typeDrug (Small molecule)
Development stage (any indication)Approved
Mechanism / classNot recorded
Data sourcesOpen Targets, ChEMBL
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 IDTitleStatusPhaseEnrolment
NCT00590863Combining Medications to Enhance Depression Outcomes
2008
completedPhase 4665
NCT00021528Sequenced Treatment Alternatives to Relieve Depression (STAR*D)
2001
completedPhase 44,000
NCT00926835Effect of Antidepressants on the Treatment for Korean Major Depressive Disorder Patients
2009
terminatedPhase 4692
NCT01305707Continuation Electroconvulsive Therapy (C-ECT) for Relapse Prevention in Major Depression
2009
terminatedPhase 4104
NCT02458690eIMPACT Trial: Modernized Collaborative Care to Reduce the Excess CVD Risk of Older Depressed Patients
2015
completedPhase 2216
NCT06309472Trial of Mirtazapine for Depression in IBD
2024
recruitingPhase 276
NCT01962753Depression in the Elderly and Cerebral Amyloid Plaques: Characterization by [18F] AV-45 Affectives Symptoms and Amyloïd Plaques (ASAP)
2012
completedNot applicable92
NCT02441387Predictors of the Outcome of Late Life Depression
2015
status unknownNot applicable120

Search ClinicalTrials.gov for newer studies

Published literature

Run the live PubMed search

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 Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.

Frequently asked questions

Is Mirtazapine approved for Major Depressive Disorder?

Mirtazapine has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Major Depressive Disorder would be drug repurposing rather than first-in-human development. This does not mean it is approved for Major Depressive Disorder. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.

Is Mirtazapine in clinical trials for Major Depressive Disorder?

ClinicalTrials.gov lists 8 registered trials linking Mirtazapine to Major Depressive Disorder: 1 is currently recruiting; 4 have completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00021528). It plans or enrolled 4000 participants. Registration activity spans 2001 to 2024.

What does the evidence show for Mirtazapine in Major Depressive Disorder?

Mirtazapine has both completed registered trials and synthesis-level publications linked to Major Depressive Disorder. 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 Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.

Cite this page

Open Source Medicine Foundation. Mirtazapine for Major Depressive Disorder: evidence, trials and status. OSMF Research Tracker. Updated 2026-07-05. https://research.opensourcemed.info/pairs/major-depressive-disorder/mirtazapine.html

Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.

Get OSMF research updates on Substack

This is a research map, not treatment advice. Evidence tiers and scores summarise what has been studied, not whether a treatment works or is safe for you.