Summary
Citalopram 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 Citalopram 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 15 publications for this pair: 5 Cochrane reviews, 3 meta-analyses, 2 systematic reviews and 5 clinical trial publications. Publication years run from 2021 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 | 15 (5 Cochrane reviews, 5 clinical trial publications, 3 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 Efficacy of Acupuncture for Mild to Moderate Depression in Older People: Protocol for a Randomized Controlled TrialFu Q, Xiao K, Zhang J et al. · JMIR research protocols · 2026 · PMID 41616126
- Clinical trial publication Further evidence of depressive symptomatology profile predicting treatment outcomeLuca M, Luca A, Serretti A · International journal of psychiatry in clinical practice · 2025 · PMID 40566739
- Clinical trial publication A large-scale multimodal investigation of the interplay between the serotonergic system and emotion processingKlöbl M, Murgaš M, Reed MB et al. · Translational psychiatry · 2025 · PMID 40500269
- Clinical trial publication Simplified methods for SERT occupancy estimation measured with [11C]DASB PET bolus plus infusionPonce de León M, Murgaš M, Silberbauer LR et al. · NeuroImage · 2025 · PMID 40221064
- 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
- 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 A Systematic Review of Antidepressants and Psychotherapy Commonly Used in the Treatment of Late Life Depression for Their Effects on CognitionNelson JC, Gandelman JA, Mackin RS · The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry · 2025 · PMID 39366871
- Clinical trial publication Pentoxifylline as a Novel Add-on Therapy for Major Depressive Disorder in Adult Patients: A Randomized, Double-Blind, Placebo-Controlled TrialMerza Mohammad TA, Merza Mohammad TA, Salman DM et al. · Pharmacopsychiatry · 2024 · PMID 38710206
- Cochrane review A Review of Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation Combined with Medication and Psychotherapy for DepressionKochanowski B, Kageki-Bonnert K, Pinkerton EA et al. · Harvard review of psychiatry · 2024 · PMID 38728568
- Systematic review Amygdala biomarkers of treatment response in major depressive disorder: An fMRI systematic review of SSRI antidepressantsTassone VK, Gholamali Nezhad F, Demchenko I et al. · Psychiatry research. Neuroimaging · 2024 · PMID 38183847
- Cochrane review Escitalopram versus other antidepressive agents for major depressive disorder: a systematic review and meta-analysisYin J, Song X, Wang C et al. · BMC psychiatry · 2023 · PMID 38001423
- Meta-analysis Antidepressants for the treatment of adults with major depressive disorder in the maintenance phase: a systematic review and network meta-analysisKishi T, Ikuta T, Sakuma K et al. · Molecular psychiatry · 2023 · PMID 36253442
- Cochrane review Efficacy and tolerability of antidepressant drugs in treatment of depression in children and adolescents: a network meta-analysisRao Y, Yang R, Zhao J et al. · Zhejiang da xue xue bao. Yi xue ban = Journal of Zhejiang University. Medical sciences · 2022 · PMID 37202104
- Meta-analysis New generation antidepressants for depression in children and adolescents: a network meta-analysisHetrick SE, McKenzie JE, Bailey AP et al. · The Cochrane database of systematic reviews · 2021 · PMID 34029378
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 Citalopram approved for Major Depressive Disorder?
Citalopram 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 Citalopram in clinical trials for Major Depressive Disorder?
ClinicalTrials.gov lists 8 registered trials linking Citalopram 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 Citalopram in Major Depressive Disorder?
Citalopram 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.