Fluoxetine
| Evidence Level: L5 | Predicted Indications: 8 |
Table of Contents
- Fluoxetine
- Pharmacist Assessment Report
- Fluoxetine: From Anxiety Disorder and Depression to Paranoid Personality Disorder
- One-Sentence Summary
- Quick Overview
- Why is This Prediction Reasonable?
- Clinical Trial Evidence
- Literature Evidence
- India Market Information
- Safety Considerations
- Conclusion and Next Steps
- Disclaimer
Fluoxetine: From Anxiety Disorder and Depression to Paranoid Personality Disorder
One-Sentence Summary
Fluoxetine is a serotonin-acting medicine whose relations recorded in the knowledge graph include anxiety disorder, major depressive disorder, bulimia nervosa and obsessive-compulsive disorder. The TxGNN model predicts it may be useful for paranoid personality disorder (top-ranked prediction), with 0 registered clinical trials and 7 publications retrieved, none of which directly studies fluoxetine in this disease. The evidence is therefore model-driven only.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Relations recorded in the knowledge graph: anxiety disorder, neurotic disorder, dysthymic disorder, bipolar disorder, unipolar depression, major depressive disorder, bulimia nervosa, obsessive-compulsive disorder (no approved indication text is available in the local licence records) |
| Predicted New Indication | Paranoid personality disorder |
| TxGNN Prediction Score | 0.9992 |
| 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. Fluoxetine is generally known as a selective serotonin reuptake inhibitor (SSRI). The prediction score comes from the TxGNN model (deep learning) and may reflect similarities the model learned between related diseases, not biological evidence. Mechanistically, serotonergic modulation may reduce anxiety, depressive comorbidity and impulsivity seen in personality disorders.
However, the retrieved literature concerns mainly borderline personality disorder, depression with personality-disorder comorbidity, and a general review of cluster A personality disorders (which include paranoid, schizoid and schizotypal types). No study reports fluoxetine specifically in paranoid personality disorder. The prediction is therefore plausible but unverified.
Because no cited study directly addresses paranoid personality disorder, the evidence level is capped at L5, even though the data compiled for this report had provisionally graded it L4.
Other predictions in the same set (for context):
- Schizotypal personality disorder: small, mostly uncontrolled fluoxetine studies (e.g., a 1991 open 12-week study of 22 patients) and one case report of transient psychosis on fluoxetine, which is a safety signal.
- Phobic disorder: a completed Phase 3 trial in childhood social phobia (NCT00043537) and SSRI meta-analyses, the strongest evidence among the predictions.
- Manic bipolar affective disorder: evidence concerns the depressive phase only and does not show benefit in mania.
- Histrionic and schizoid personality disorders, benign paroxysmal torticollis of infancy, Ohdo syndrome: no relevant fluoxetine evidence.
Clinical Trial Evidence
Currently no related clinical trials registered for paranoid personality disorder.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 29955451 | 2016 | Review | Ment Health Clin | Reviews drug treatment of cluster A personality disorders (paranoid, schizoid, schizotypal); general context, no fluoxetine-specific efficacy data for the paranoid type |
| 36853245 | 2023 | Review | JAMA | Review of borderline personality disorder; not specific to the paranoid type |
| 12524634 | 2003 | Cohort | Compr Psychiatry | 183 depressed patients in a fluoxetine vs nortriptyline trial; compares those with borderline, other and no personality disorders |
| 12214786 | 2002 | Review | Psychol Med | Personality disorder diagnoses in depressed outpatients before and after fluoxetine treatment |
| 17637578 | 2000 | Cohort | CNS Spectr | Social anxiety and premorbid personality disorders in paranoid schizophrenia patients on clozapine; not fluoxetine |
| 21371699 | 2011 | Cohort | Compr Psychiatry | Characteristics of childhood-, teenage- and adult-onset depression |
| 26703328 | 2016 | Review | J Dev Behav Pediatr | Case discussion of psychiatric diagnoses and polycystic ovarian syndrome; not relevant |
India Market Information
At least 20 single-ingredient fluoxetine licences are recorded, and the list may be partial. The licence records contain no approved indication text. Up to 5 are shown below.
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 69745 | Depcure 20mg Capsule | Strip of 10 capsules | Not stated in the records |
| 88510 | Fluget 20mg Tablet | Strip of 10 tablets | Not stated in the records |
| 62428 | Depzac 20mg Capsule (Cipla Ltd) | Strip of 10 capsules | Not stated in the records |
| 87032 | Fluz OD Tablet | Strip of 1 tablet | Not stated in the records |
| 152127 | Nodep 20mg Capsule | Strip of 10 capsules | Not stated in the records |
Safety Considerations
- Contraindications: The knowledge graph records contraindication relations (not label text) with conditions including bipolar disorder, epilepsy, liver failure and cirrhosis, diabetes and diabetic ketoacidosis, neutropenia and agranulocytosis, benign prostatic hyperplasia, orthostatic hypotension, blood coagulation disease, hyperlipidemia, stroke and cerebrovascular disorders, and myocardial infarction.
- Drug Interactions: 360 interactions are recorded. Major-level examples include bupropion, lorcaserin, diethylpropion, dolasetron, eliglustat, palonosetron and cisapride. Moderate-level examples include aspirin, morphine, clarithromycin, famotidine and loperamide.
- Signals from the retrieved literature: A case report describes transient psychosis with psychogenic polydipsia in a schizotypal patient taking fluoxetine. Another reports apathy and indifference on SSRIs. Pediatric use carries a suicidality warning for antidepressants.
Please refer to the package insert for label warnings, which were not available in the data compiled for this report.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction for paranoid personality disorder rests on a high model score and indirect literature about other personality disorders. No trial or publication studies fluoxetine in this disease, so the evidence is L5. The safety profile also carries a substantial interaction burden and several knowledge-graph contraindications.
To proceed, the following is needed:
- Fluoxetine-specific clinical data in paranoid personality disorder, or at least in cluster A personality disorders
- Mechanism of action data (currently missing)
- Package insert warnings and contraindications from the Indian licence holders
- A safety review covering psychosis-related signals and drug interactions
- Consideration of the better-supported prediction, phobic disorder (Phase 3 NCT00043537 and SSRI meta-analyses), as a priority candidate, after verifying fluoxetine’s role in that trial
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.