Paroxetine
| Evidence Level: L5 | Predicted Indications: 1 |
Table of Contents
Paroxetine: Ohdo syndrome and variants
One-Sentence Summary
Paroxetine is a selective serotonin reuptake inhibitor (SSRI) originally used for depressive and anxiety-related disorders, including major depressive disorder, obsessive-compulsive disorder, social phobia and post-traumatic stress disorder. The TxGNN model predicts it may be effective for Ohdo syndrome and variants, but there are currently 0 clinical trials and 0 publications supporting this direction. The prediction rests on the computational score alone.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Ohdo syndrome and variants |
| TxGNN Prediction Score | 0.9911 |
| Evidence Level | L5 |
| 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 | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available from the data compiled for this report. Paroxetine is generally known as an SSRI, and its efficacy in depression and anxiety-spectrum disorders is established. This general knowledge was not supplied in the compiled data, however.
Ohdo syndrome (including the Say-Barber-Biesecker-Young-Simpson variant) is a rare congenital disorder with intellectual disability. It is typically associated with KAT6B variants that affect chromatin regulation. No plausible link between SSRI pharmacology and this genetic pathology can be established from the available data.
The high score most likely reflects proximity in the knowledge network, for example shared neurodevelopmental or psychiatric phenotype nodes, rather than a causal therapeutic mechanism. The prediction should be treated as a hypothesis only.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
India Market Information
Paroxetine has 20 valid single-ingredient registrations in India, all oral tablets (mostly controlled-, extended- or prolonged-release forms). No approved indication text is available for any of them. Five main registrations are listed below.
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 201999 | Senoxetin CR 25 Tablet | Strip of 10 CR tablets | Not available |
| 176000 | Paxiford 12.5mg Tablet CR | Strip of 10 CR tablets | Not available |
| 176014 | Parol 25mg Tablet | Strip of 10 tablets | Not available |
| 176217 | Prx 20mg Tablet | Strip of 10 tablets | Not available |
| 174385 | Paradise XR 12.5 Tablet | Strip of 10 PR tablets | Not available |
Safety Considerations
- Knowledge-graph contraindications (not label text): epilepsy, bipolar disorder, major affective disorder, liver disease, gallbladder disease, blood coagulation disease, neuroleptic malignant syndrome, inappropriate ADH syndrome, nephrogenic syndrome of inappropriate antidiuresis, serotonin syndrome, drug-induced akathisia, and pathologic fracture (an obsolete term in the ontology).
- Drug Interactions: 327 interactions were recorded. Major-level ones in the sample reviewed include:
- Bupropion
- Lorcaserin
- Diethylpropion
- Dolasetron
- Eliglustat
- Palonosetron
- Phentermine
Moderate-level examples include morphine, acetylsalicylic acid, cimetidine, clarithromycin, chlorpropamide, glimepiride and repaglinide.
Package insert warnings and contraindications were not available, so please refer to the package insert for complete safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The only support is a computational prediction score, with no clinical trials, no literature and no plausible mechanistic link between SSRI pharmacology and the genetic basis of Ohdo syndrome. This does not justify advancing at this stage.
To proceed, the following is needed:
- Package insert warnings and contraindications from the India Pharma source, which is required for safety screening
- Detailed mechanism of action data
- A mechanistic rationale connecting paroxetine to KAT6B-related chromatin regulation or the syndrome’s phenotypes
- Preclinical or case-level evidence in Ohdo syndrome models or patients
- An assessment of whether the rare-disease population and available dosage forms are compatible
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.