Summary
Escitalopram 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 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 16 publications for this pair: 5 Cochrane reviews, 4 meta-analyses, 2 systematic reviews and 5 clinical trial publications. Publication years run from 2024 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.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 80.0 (trials 30.0, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 2 recruiting, 0 active / not yet recruiting, 6 completed, 0 other |
| Linked publications | 16 (5 Cochrane reviews, 5 clinical trial publications, 4 meta-analyses, 2 systematic reviews) |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
| NCT01312922 | Pipamperone/Citalopram (PNB01) Versus Citalopram (CIT) and Versus Pipamperone (PIP) in Major Depressive Disorder (MDD) 2011 | completed | Phase 3 | 555 |
| 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 Obesity-related differences in amygdala and hippocampal volume and metabolism before and after a placebo-controlled antidepressant trial in major depressive disorderLin K, Hasegawa K, Rapelli V et al. · Scientific reports · 2026 · PMID 41820539
- Clinical trial publication Identification of antidepressant response-related changes to DNA methylation and gene expressionFiori LM, Nagy C, Turecki G · The international journal of neuropsychopharmacology · 2026 · PMID 41593764
- Clinical trial publication Modulation of Brain Temporal Complexity During Treatment for Depression: A CAN-BIND-1 Study Report: Modulation de la complexité temporelle du cerveau pendant le traitement de la dépression: rapport de l'étude CAN-BIND-1Stengel C, Schwartzmann B, Chatterjee R et al. · Canadian journal of psychiatry. Revue canadienne de psychiatrie · 2026 · PMID 41452049
- Cochrane review Preventing relapse in patients with major depressive disorder after an effective acute course of electroconvulsive therapySong M, Launder NH, Phutane VH et al. · Australasian psychiatry : bulletin of Royal Australian and New Zealand College of Psychiatrists · 2026 · PMID 41138242
- Meta-analysis Modeling the efficacy of a novel antidepressant zuranolone for major depressive disorderLiu J, Hong L, Qian Y et al. · Journal of affective disorders · 2026 · PMID 40876640
- Systematic review Subgenual anterior cingulate cortex and antidepressant response to serotonergic and glutamatergic pharmacological treatments: a systematic review of neuroimaging studiesSousa-Ho RL, Demchenko I, Baltazar VA et al. · Progress in neuro-psychopharmacology & biological psychiatry · 2026 · PMID 41564918
- Clinical trial publication Tetrahydrocurcumin for Major Depressive Disorder with Therapeutic Potential and Mechanistic Insights from Clinical and Preclinical StudiesGuo Y, Xie J, Luo H et al. · Molecular neurobiology · 2025 · PMID 41432971
- Clinical trial publication Whole blood BDNF is lower in patients with depression and unchanged by escitalopram in patients and healthy controlsNavarro ML, Breum AW, Ozenne B et al. · Progress in neuro-psychopharmacology & biological psychiatry · 2025 · PMID 40816605
- Cochrane review Side effect profile and comparative tolerability of newer generation antidepressants in the acute treatment of major depressive disorder in children and adolescents: protocol for a systematic review and network meta-analysisTürkmen C, Sacu S, Furukawa Y et al. · BMJ open · 2025 · PMID 41062142
- Cochrane review Effects of the selective serotonin reuptake inhibitors citalopram and escitalopram on glucolipid metabolism: a systematic reviewDai Y, Zhao M, Li M et al. · Frontiers in endocrinology · 2025 · PMID 40600014
- Cochrane review Augmentation Therapy With Serotonin 5-HT(1A) Receptor Partial Agonists on Cognitive Function in Depressive Disorders: A Systematic Review of Randomized Controlled StudiesYamada R, Wada A, Stickley A et al. · Neuropsychopharmacology reports · 2025 · PMID 40421605
- Cochrane review Comparative efficacy of antidepressant medication for adolescent depression: a network meta-analysis and systematic reviewWu T, Song F, Cao W et al. · BMC psychiatry · 2025 · PMID 40349006
- Meta-analysis Effect of antidepressants on ejaculation dysfunction in patients with depression and anxiety: A systematic review and network meta-analysisWang Q, Xu Z, Chen X et al. · Andrology · 2025 · PMID 39344496
- Meta-analysis Probiotics for adults with major depressive disorder compared with antidepressants: a systematic review and network meta-analysisZhao S, Liang S, Tao J et al. · Nutrition reviews · 2025 · PMID 38219239
- Systematic review Escitalopram and functional connectivity in major depressive disorder: A systematic reviewTuriaco F, Arnone F, Drago A et al. · Journal of psychopharmacology (Oxford, England) · 2025 · PMID 41025521
- Meta-analysis Antidepressants available in Japan for older people with major depressive disorder: A systematic review and meta-analysisKishi T, Sakuma K, Hatano M et al. · Neuropsychopharmacology reports · 2024 · PMID 38318955
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 approved for Major Depressive Disorder?
Escitalopram 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 in clinical trials for Major Depressive Disorder?
ClinicalTrials.gov lists 8 registered trials linking Escitalopram 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 in Major Depressive Disorder?
Escitalopram 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
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.