Paroxetine
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
Paroxetine: From Depression and Anxiety Disorders to Ohdo Syndrome and Variants
One-Sentence Summary
Paroxetine is a selective serotonin reuptake inhibitor (SSRI), originally used for depression and anxiety-related disorders. The TxGNN model predicts it may be effective for Ohdo syndrome and variants, a rare genetic disorder. This prediction currently has 0 clinical trials and 0 publications behind it, so it rests on the model score alone.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the Singapore licence record. Per the knowledge graph: anxiety disorder, major depressive disorder, obsessive-compulsive disorder, post-traumatic stress disorder, social phobia and related conditions |
| Predicted New Indication | Ohdo syndrome and variants |
| TxGNN Prediction Score | 99.11% |
| Evidence Level | L5 |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 1 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available in the data compiled for this report. Based on known information, paroxetine is a potent and selective serotonin reuptake inhibitor. Its efficacy in depression and anxiety disorders is well established.
For Ohdo syndrome, no mechanistic link has been established. Ohdo syndrome is a rare genetic disorder, typically associated with KAT6B, and has no known serotonergic pathway that would justify using paroxetine. The high score (0.991) is a graph-based prediction only. It likely reflects the structure of the knowledge graph rather than biological or clinical evidence.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
Singapore Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| SIN13485P | Apo-Paroxetine 20mg Tablet (Apotex Inc) | Tablet, film coated (oral) | Not listed in the licence record |
Safety Considerations
- Contraindications (knowledge-graph based, not label text): The knowledge graph links paroxetine to the following conditions: epilepsy, bipolar disorder, major affective disorder, liver disease, gallbladder disease, blood coagulation disease, neuroleptic malignant syndrome, inappropriate ADH syndrome (including the nephrogenic form), serotonin syndrome and drug-induced akathisia.
- Drug Interactions: 100 interactions are recorded. Major-level interactions include bupropion, lorcaserin, diethylpropion, phentermine, dolasetron, palonosetron and eliglustat. Moderate-level interactions include morphine, acetylsalicylic acid, cimetidine, clarithromycin, chlorpropamide, glimepiride and repaglinide.
Please refer to the package insert for label warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction has no clinical trials, no literature and no plausible mechanistic link to paroxetine. Evidence is at L5 (model prediction only), so it does not justify further investment at present.
To proceed, the following is needed:
- A biological rationale connecting serotonin reuptake inhibition to KAT6B-related or Ohdo-type pathology
- Preclinical or case-level evidence of any benefit
- Mechanism of action data and the package insert warnings and contraindications for the Singapore-registered product
- Note that the closely related TxGNN predictions for the same drug, melancholia (L1) and agoraphobia (L1), are supported by clinical trials and literature. They are better candidates for further evaluation.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.