Fluvoxamine

Evidence Level: L5 Predicted Indications: 9

Table of Contents

  1. Fluvoxamine
    1. Pharmacist Assessment Report
    2. Fluvoxamine: Schizotypal personality disorder
    3. One-Sentence Summary
    4. Quick Overview
    5. Why is This Prediction Reasonable?
    6. Clinical Trial Evidence
    7. Literature Evidence
    8. India Market Information
    9. Safety Considerations
    10. Conclusion and Next Steps
    11. Disclaimer

Pharmacist Assessment Report

Fluvoxamine: Schizotypal personality disorder

One-Sentence Summary

Fluvoxamine is a selective serotonin reuptake inhibitor (SSRI) that is marketed in India in single-ingredient tablet products. The TxGNN model predicts it may be useful for Schizotypal Personality Disorder, but no clinical trials and only 5 indirect publications (case reports, an open-label augmentation study and comorbidity observations) are available, so this is a computational hypothesis rather than an evidence-backed direction.


Quick Overview

Item Content
Original Indication Not recorded in the local data
Predicted New Indication Schizotypal personality disorder
TxGNN Prediction Score 1.0000
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?

Detailed mechanism-of-action data for fluvoxamine are not available in the data compiled for this report. Fluvoxamine is known as a potent SSRI that blocks the serotonin transporter (SERT). The link to schizotypal personality disorder is indirect. Schizotypal traits often co-occur with obsessive-compulsive symptoms, which respond to serotonergic drugs, so a serotonin-based effect on obsessive and anxious features is plausible.

The literature found does not test fluvoxamine as a treatment for schizotypal personality disorder. In one report, patients with a comorbid schizotypal personality disorder were more likely to respond when an antipsychotic was added to fluvoxamine. This suggests that fluvoxamine alone may not be enough for these patients. The very high TxGNN score is shared with several other personality-disorder predictions, so it more likely reflects similarity between diseases in the model than disease-specific evidence.


Clinical Trial Evidence

Currently no related clinical trials registered.


Literature Evidence

PMID Year Type Journal Key Findings
11063782 2000 Open-label trial Psychiatry Res 12-week olanzapine augmentation in fluvoxamine-refractory OCD (n=23); examined whether comorbid schizotypal personality disorder was linked to response
1970224 1990 Case series Am J Psychiatry 9 of 17 fluvoxamine-refractory OCD patients responded to added neuroleptic; schizotypal personality disorder or tic disorders were associated with response
14999178 2004 Case report CNS Spectr Compulsive hoarding with ADHD and schizotypal personality disorder; fluvoxamine, amphetamine salts, risperidone and behavioural therapy together improved hoarding and motivation
16146185 2005 Case report Seishin Shinkeigaku Zasshi OCD with neuroleptic-induced deficit syndrome in a man with schizotypal-type personality; improved after stopping neuroleptics and starting fluvoxamine
8473723 1993 Case report Int Clin Psychopharmacol Seizures after combined levomepromazine and fluvoxamine; safety signal for combination with phenothiazines

India Market Information

Fluvoxamine is marketed in India, with 20 valid single-ingredient licences. The list below shows 5 of them and may be partial. Approved-indication text is not recorded in the local data.

Authorization Number Product Name Dosage Form Manufacturer
84492 Frext 50 Tablet Tablet (strip of 10) Intas Pharmaceuticals Ltd
84182 Fluvoxin 50 Tablet Tablet (strip of 10) Sun Pharmaceutical Industries Ltd
84452 Fluvoxin CR 50 Tablet Extended-release tablet (strip of 10) Sun Pharmaceutical Industries Ltd
85075 Flumin 100mg Tablet Tablet (strip of 10) Psycogen Captab
233810 Voxamin 100 Tablet Tablet (strip of 10) Micro Labs Ltd

Safety Considerations

  • Conditions of concern (not taken from package-insert text): epilepsy, bipolar disorder and other major affective disorders, liver disease, gallbladder disease, blood coagulation disorders, neuroleptic malignant syndrome, inappropriate ADH secretion (SIADH), and serotonin syndrome.
  • Drug Interactions: 283 interactions are recorded. Major-level ones include alosetron, diethylpropion, dolasetron and bupropion. Moderate-level ones include rabeprazole, clarithromycin, aspirin, morphine, pioglitazone, aprepitant and several corticosteroids (hydrocortisone, dexamethasone, budesonide).
  • Combination with antipsychotics: one published case describes seizures when fluvoxamine was combined with the phenothiazine levomepromazine. This matters because antipsychotic augmentation is the context of the schizotypal-related literature.

Please refer to the package insert for full warnings and contraindications.


Conclusion and Next Steps

Decision: Hold

Rationale: The prediction rests on a model score alone. There are no registered trials and no study testing fluvoxamine in schizotypal personality disorder. The available papers are case reports and comorbidity observations in OCD, so the evidence level is L5.

To proceed, the following is needed:

  • Controlled studies, or at least systematic case data, of fluvoxamine in people diagnosed with schizotypal personality disorder
  • Detailed mechanism-of-action data and a rationale specific to this disorder
  • Package-insert warnings and contraindications for the marketed Indian products
  • A safety plan for combinations with antipsychotics (seizure risk) and for the major drug interactions

Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.



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