Summary
Citalopram Hydrobromide 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8 registered trials linking Citalopram Hydrobromide to Major Depressive Disorder: 6 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT04975724). The largest enrolment is 555 participants (NCT01312922). Registration activity spans 2005 to 2019. The literature layer holds 4 publications for this pair: 4 clinical trial publications. Publication years run from 2007 to 2026. 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 | 55.5 (trials 27.5, literature 8.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 0 active / not yet recruiting, 6 completed, 2 other |
| Linked publications | 4 (4 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT01557946 | Glutamatergic and GABAergic Mediators of Antidepressant Response in Major Depression 2012 | completed | Phase 4 | 32 |
| NCT01305707 | Continuation Electroconvulsive Therapy (C-ECT) for Relapse Prevention in Major Depression 2009 | terminated | Phase 4 | 104 |
| NCT04975724 | Safety of Liposom With Citalopram in Elderly Patients With Major Depressive Disorder 2019 | status unknown | Phase 4 | 150 |
| NCT01312922 | Pipamperone/Citalopram (PNB01) Versus Citalopram (CIT) and Versus Pipamperone (PIP) in Major Depressive Disorder (MDD) 2011 | completed | Phase 3 | 555 |
| 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 |
| NCT02458690 | eIMPACT Trial: Modernized Collaborative Care to Reduce the Excess CVD Risk of Older Depressed Patients 2015 | completed | Phase 2 | 216 |
| NCT00993876 | Cognitive Flexibility in Major Depression in the Course of Pharmacological and Psychotherapeutic Treatment 2005 | completed | Not applicable | 45 |
| NCT00655057 | Effects of Antidepressant Therapy on Brain Dopamine Transporter Activity in People With Major Depression 2005 | completed | PHASE2, PHASE3 | 66 |
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 Selecting among second-step antidepressant medication monotherapies: predictive value of clinical, demographic, or first-step treatment featuresRush AJ, Wisniewski SR, Warden D et al. · Archives of general psychiatry · 2008 · PMID 18678792
- Clinical trial publication A randomized, placebo-controlled trial of citalopram for the prevention of major depression during treatment for head and neck cancerLydiatt WM, Denman D, McNeilly DP et al. · Archives of otolaryngology--head & neck surgery · 2008 · PMID 18490576
- Clinical trial publication Association between treatment-emergent suicidal ideation with citalopram and polymorphisms near cyclic adenosine monophosphate response element binding protein in the STAR*D studyPerlis RH, Purcell S, Fava M et al. · Archives of general psychiatry · 2007 · PMID 17548750
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 Hydrobromide approved for Major Depressive Disorder?
Citalopram Hydrobromide 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 Hydrobromide in clinical trials for Major Depressive Disorder?
ClinicalTrials.gov lists 8 registered trials linking Citalopram Hydrobromide to Major Depressive Disorder: 6 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT04975724). The largest enrolment is 555 participants (NCT01312922). Registration activity spans 2005 to 2019.
What does the evidence show for Citalopram Hydrobromide in Major Depressive Disorder?
Citalopram Hydrobromide has 6 completed trials and 4 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.