Summary
Escitalopram Oxalate 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 Escitalopram Oxalate to Major Depressive Disorder: 2 are currently recruiting; 6 have completed. The most advanced is Phase 4 (NCT07478796). The largest enrolment is 976 participants (NCT01369095). Registration activity spans 2002 to 2025. The literature layer holds 5 publications for this pair: 5 clinical trial publications. Publication years run from 2013 to 2020. These are primary trial reports rather than syntheses, so results have not yet been pooled or graded independently.
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.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 60.0 (trials 30.0, literature 10.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 2 recruiting, 0 active / not yet recruiting, 6 completed, 0 other |
| Linked publications | 5 (5 clinical trial publications) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT00166114 | Depression, Epinephrine, and Platelet Function 2002 | completed | Phase 4 | 40 |
| NCT00464711 | Brain GABA Levels and Treatment Response in Major Depressive Disorder 2006 | completed | Phase 4 | 40 |
| NCT01198795 | Safety Study of Escitalopram in Children 7 to 11 Years of Age With Major Depressive Disorder 2010 | completed | Phase 4 | 162 |
| NCT07478796 | TDM-Guided Treatment With SSRIs in Hospitalized Adults and Children 2025 | recruiting | Phase 4 | 180 |
| NCT01838876 | Long-term Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy in Patients With Major Depressive Disorder 2013 | completed | Phase 3 | 442 |
| NCT01034995 | A Trial Evaluating the Efficacy and Tolerability of SSR125543 in Outpatients With Major Depressive Disorder 2010 | completed | Phase 2 | 580 |
| NCT01369095 | Efficacy and Safety of Fixed Doses of BMS 820836 in the Treatment of Patients With Treatment Resistant Major Depression 2011 | completed | Phase 2 | 976 |
| NCT05002309 | Treatment Interrupts Depression Early 2021 | recruiting | Phase 2 | 100 |
Published literature
- Clinical trial publication Evaluation of a Machine Learning Model Based on Pretreatment Symptoms and Electroencephalographic Features to Predict Outcomes of Antidepressant Treatment in Adults With Depression: A Prespecified Secondary Analysis of a Randomized Clinical TrialRajpurkar P, Yang J, Dass N et al. · JAMA network open · 2020 · PMID 32568399
- Clinical trial publication Neuronavigation-Guided rTMS for the Treatment of Depressive Patients With Suicidal Ideation: A Double-Blind, Randomized, Sham-Controlled TrialPan F, Shen Z, Jiao J et al. · Clinical pharmacology and therapeutics · 2020 · PMID 32319673
- Clinical trial publication Efficacy and safety of bupropion hydrochloride extended-release versus escitalopram oxalate in Chinese patients with major depressive disorder: Results from a randomized, double-blind, non-inferiority trialShen Y, Zhao Q, Yu Y et al. · Journal of affective disorders · 2019 · PMID 31301615
- Clinical trial publication Prevention of depression with escitalopram in patients undergoing treatment for head and neck cancer: randomized, double-blind, placebo-controlled clinical trialLydiatt WM, Bessette D, Schmid KK et al. · JAMA otolaryngology-- head & neck surgery · 2013 · PMID 23788218
- Clinical trial publication Toward a neuroimaging treatment selection biomarker for major depressive disorderMcGrath CL, Kelley ME, Holtzheimer PE et al. · JAMA psychiatry · 2013 · PMID 23760393
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 Escitalopram Oxalate approved for Major Depressive Disorder?
Escitalopram Oxalate 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 Escitalopram Oxalate in clinical trials for Major Depressive Disorder?
ClinicalTrials.gov lists 8 registered trials linking Escitalopram Oxalate to Major Depressive Disorder: 2 are currently recruiting; 6 have completed. The most advanced is Phase 4 (NCT07478796). The largest enrolment is 976 participants (NCT01369095). Registration activity spans 2002 to 2025.
What does the evidence show for Escitalopram Oxalate in Major Depressive Disorder?
Escitalopram Oxalate has 6 completed trials and 5 linked publications for Major Depressive Disorder. Completed trials may or may not have posted results; follow the NCT links to check. 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
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.