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 India as a single-ingredient oral tablet. The TxGNN model predicts it may be effective for obsessive-compulsive disorder, with 4 clinical trials and 16 publications compiled for this direction. The evidence is at Level L2: citalopram itself has been tested in obsessive-compulsive disorder only in one small single-blind comparison and several open-label studies, with no placebo-controlled phase 3 trial.
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 |
| India Market Status | Listed in a compiled Indian medicine price dataset (at least 20) – CDSCO approval status is not included in this data |
| Number of Listed Products | at least 20 |
| Recommended Decision | Proceed with Guardrails |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the compiled data. Based on known class pharmacology, citalopram is a selective serotonin reuptake inhibitor that raises serotonin availability in the brain.
Obsessive-compulsive disorder is known to respond to serotonin reuptake inhibition. Other SSRIs, such as fluoxetine (used as the comparator in one of the listed trials), are established treatments for it. Citalopram shares this mechanism, which is consistent with the high TxGNN score.
One caution: the larger trials listed below support the SSRI class and combined drug-plus-behavioural treatment strategies in obsessive-compulsive disorder, not citalopram specifically. Citalopram-specific data come mainly from small and open-label studies.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT02022709 | Phase 4 | Completed | 78 | Exposure and response prevention, SSRIs and their combination in obsessive-compulsive disorder, plus predictors of response in a Chinese population |
| NCT00074815 | Phase 3 | Completed | 124 | Cognitive behavioural therapy added to serotonin reuptake inhibitor treatment in children who only partly responded; the drug is not confirmed to be citalopram |
| NCT00680602 | Phase 4 | Completed | 158 | Group cognitive behavioural therapy vs fluoxetine; the drug arm is fluoxetine, so this is class-level support only |
| NCT02285699 | Not applicable | Completed | 43 | Pilot study of gut microbiota before and after 12 weeks of SSRI treatment; not an efficacy trial |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 9241005 | 1997 | Single-blind comparison | J Clin Psychopharmacol | Compared the anti-obsessional efficacy of fluvoxamine, paroxetine and citalopram in 30 patients |
| 10572334 | 1999 | Randomized open-label trial | Eur Psychiatry | Citalopram alone vs citalopram plus clomipramine in 16 patients with treatment-resistant obsessive-compulsive disorder |
| 9395151 | 1997 | Open pilot study | Acta Psychiatr Scand | 24-week open study of citalopram in obsessive-compulsive disorder |
| 15089116 | 2004 | Cohort (preliminary) | CNS Drugs | Relationship between citalopram blood concentrations and clinical response |
| 12839522 | 2003 | Open-label study (paediatric) | Psychiatry Clin Neurosci | 8-week open study of citalopram (mean 24 mg/day) in 15 children and adolescents |
| 9466233 | 1997 | Open-label trial (paediatric) | J Child Adolesc Psychopharmacol | 23 young patients on citalopram for 10 weeks; symptom scores improved significantly (Y-BOCS 30 to 21) |
| 10471169 | 1999 | Review/Commentary | Int Clin Psychopharmacol | Discusses citalopram for obsessive-compulsive disorder beyond depression |
| 20712565 | 2010 | Review | Curr Med Chem | Past, present and future drugs for obsessive-compulsive disorder; SSRIs are central to treatment |
| 12607204 | 2000 | Review | World J Biol Psychiatry | Serotonin and other mechanisms in obsessive-compulsive disorder |
| 22305974 | 2012 | Review | BMJ Clin Evid | Overview of obsessive-compulsive disorder and its treatments |
India Market Information
Citalopram has 20 valid single-ingredient registrations in India (the list may be partial). Approved indication text is not recorded for these licences.
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 51897 | Citadelm 20mg Tablet | Strip of 10 tablets | Not specified |
| 46198 | Cytop 20mg Tablet | Strip of 10 tablets | Not specified |
| 42439 | Cita 40mg Tablet | Strip of 10 tablets | Not specified |
| 41468 | C Pram 5mg Tablet | Strip of 10 tablets | Not specified |
| 49382 | Citosys 10mg Tablet | Strip of 10 tablets | Not specified |
Safety Considerations
- Contraindication-related conditions (from drug-disease records, not label text): long QT syndrome (including familial), torsades de pointes, epilepsy, bipolar disorder, major affective disorder, liver disease, gallbladder disease, potassium deficiency, blood coagulation disease, heart disease, cardiovascular disease, neuroleptic malignant syndrome, syndrome of inappropriate ADH secretion, and serotonin syndrome.
- Drug Interactions: 414 interactions are recorded. Major-level examples include bupropion, omeprazole, cimetidine, cisapride, clarithromycin, lorcaserin, dexfenfluramine, diethylpropion and dolasetron. Several of these (cisapride, clarithromycin, dolasetron) fit the QT-prolongation concern above. Moderate examples include acetylsalicylic acid, morphine, famotidine and loperamide.
Please also refer to the package insert for full warnings and contraindications.
Conclusion and Next Steps
Decision: Proceed with Guardrails
Rationale: Citalopram has been tested directly in obsessive-compulsive disorder, but only in one small single-blind comparison and several open-label studies. The larger trials support the SSRI class rather than citalopram specifically (Level L2). The mechanism is plausible, and the drug is widely marketed in India.
To proceed, the following is needed:
- A randomized, placebo-controlled trial of citalopram in obsessive-compulsive disorder
- Package insert warnings and contraindications for the Indian products
- A cardiac (QT) risk review and a plan to screen interacting drugs
- Dosing and safety review for paediatric use, given that the citalopram data in young patients are open-label only
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.