Citalopram
| Evidence Level: L2 | Predicted Indications: 5 |
Table of Contents
Citalopram: Obsessive-compulsive disorder
One-Sentence Summary
Citalopram is a selective serotonin reuptake inhibitor (SSRI) marketed in Australia. The TxGNN model predicts it may be effective for obsessive-compulsive disorder, a prediction with a score of 0.9974. The data compiled for this report include 4 registered clinical trials (none confirmed to test citalopram specifically) and 16 publications, several of which study citalopram directly in this condition. The evidence level is L2.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Obsessive-compulsive disorder |
| TxGNN Prediction Score | 0.9974 |
| Evidence Level | L2 |
| Australia Market Status | Listed on the PBS Schedule (1 of 1 items) – TGA (ARTG) registration status is not included in this data |
| Number of PBS Items | 1 (valid: 1) |
| Recommended Decision | Proceed with Guardrails |
Why is This Prediction Reasonable?
Detailed mechanism of action data are not available in the data compiled for this report. Based on its drug class, citalopram is a highly selective serotonin reuptake inhibitor, and its mechanism is inferred from that class rather than from a recorded mechanism entry.
Obsessive-compulsive disorder (OCD) is known to respond to serotonergic medication. Reviews in the compiled literature describe serotonin reuptake inhibitors as a mainstay of pharmacological treatment. Citalopram-specific studies include a randomised open-label trial in treatment-resistant adult OCD, a single-blind comparison with fluvoxamine and paroxetine, a citalopram concentration–response study, and open-label trials in children and adolescents. Together these support a mechanistic and clinical link, although none is a placebo-controlled phase 3 trial.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrolment | Key Findings |
|---|---|---|---|---|
| NCT00074815 | Phase 3 | Completed | 124 | Cognitive behavioural therapy added to serotonin reuptake inhibitor treatment in children with OCD who partially responded; citalopram not named as the study drug |
| NCT02022709 | Phase 4 | Completed | 78 | Exposure and response prevention, SSRIs, and their combination in OCD; predictors of response in a Chinese population |
| NCT00680602 | Phase 4 | Completed | 158 | Group cognitive behavioural therapy versus fluoxetine in OCD; citalopram not the study drug |
| NCT02285699 | Not applicable | Completed | 43 | Pilot study of gut microbiota in OCD versus healthy controls, then after 12 weeks of open-label SSRI treatment; not a test of citalopram |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 9241005 | 1997 | Single-blind comparison | J Clin Psychopharmacol | Compared the antiobsessional efficacy of fluvoxamine, paroxetine and citalopram in 30 patients with OCD |
| 10572334 | 1999 | Randomised open-label trial | Eur Psychiatry | Citalopram alone versus citalopram plus clomipramine in 16 adults with treatment-resistant OCD |
| 9395151 | 1997 | Open pilot study | Acta Psychiatr Scand | 24-week open pilot study of citalopram in OCD |
| 12839522 | 2003 | Open-label study | Psychiatry Clin Neurosci | 8-week study of citalopram (mean 24 mg/day) in 15 children and adolescents with OCD |
| 9466233 | 1997 | Open-label trial | J Child Adolesc Psychopharmacol | 23 children and adolescents treated with citalopram for 10 weeks; significant improvement in Y-BOCS/CY-BOCS scores (30 to 21) |
| 15089116 | 2004 | Cohort | CNS Drugs | Preliminary study of the relationship between citalopram concentrations and clinical response in OCD |
| 10471169 | 1999 | Review | Int Clin Psychopharmacol | Review of citalopram for OCD and the role of serotonin reuptake inhibitors |
| 22305974 | 2012 | Review | BMJ Clin Evid | Overview of OCD epidemiology and treatment |
Australia Market Information
| ARTG Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| ARTG 14313H | Celapram | Tablet 10 mg (as hydrobromide) | Not recorded in the local data |
At least one valid licence is held, and the drug is marketed in Australia in an oral tablet form.
Safety Considerations
Drug Interactions (100 interactions recorded; examples of those rated Major):
- Bupropion
- Omeprazole
- Cimetidine
- Cisapride
- Clarithromycin
- Lorcaserin
- Dexfenfluramine
- Diethylpropion
- Dolasetron
Moderate and minor interactions are also recorded (for example famotidine, loperamide, morphine, acetylsalicylic acid and clotrimazole). Several of the Major interactions involve QT-prolonging or serotonergic drugs, so review any co-prescribed medicines carefully.
For warnings and contraindications, please refer to the TGA-approved Product Information (PI).
Conclusion and Next Steps
Decision: Proceed with Guardrails
Rationale: Citalopram has direct, though limited, clinical evidence in OCD: one small single-blind comparison and several open-label studies, in adults and in children. There is no placebo-controlled phase 3 trial. The evidence level is L2, and the high TxGNN score (0.9974) is consistent with the clinical data.
To proceed, the following is needed:
- Controlled trial data (ideally placebo-controlled) specific to citalopram in OCD
- Detailed mechanism of action data
- Review of TGA Product Information for warnings and contraindications, with particular attention to QT prolongation and serotonergic interactions
- A monitoring plan for children, adolescents and patients taking interacting medicines
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.