Mianserin
| Evidence Level: L5 | Predicted Indications: 4 |
Table of Contents
Mianserin: Benign paroxysmal torticollis of infancy
One-Sentence Summary
Mianserin is a tetracyclic antidepressant, originally used for depressive disorders and anxiety. The TxGNN model predicts it may be effective for benign paroxysmal torticollis of infancy, but there are currently 0 clinical trials and 0 publications supporting this specific prediction.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Benign paroxysmal torticollis of infancy |
| TxGNN Prediction Score | 0.9949 |
| Evidence Level | L5 |
| Australia Market Status | Listed on the PBS Schedule (1 of 1 items) – TGA (ARTG) registration status is not included in this data |
| Number of PBS Items | 1 (valid: 1) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the data compiled for this report. The pharmacology data show that mianserin binds several serotonin receptors (5-HT1B, 5-HT2A, 5-HT2B, 5-HT2C, 5-HT6, 5-HT7), alpha-1 adrenoceptors (1A, 1B, 1D), the LPA1 receptor and the noradrenaline transporter (NET). Mianserin is generally described as an antagonist of alpha-2 adrenergic, 5-HT2 and H1 receptors, but the binding data above do not state the direction of action.
Benign paroxysmal torticollis of infancy is a paediatric, migraine-related condition associated with CACNA1A (a calcium channel gene). No plausible mechanistic link between an antidepressant and this condition has been established. The high TxGNN score (0.9949) comes from the TxGNN model (deep learning) and may reflect similarities the model learned between related diseases, not biological evidence. It should not be read as evidence of clinical benefit.
Other predictions to note: Several lower-ranked predictions are more clinically coherent because they sit within or near mianserin’s existing depression and anxiety uses:
- Neurotic disorder (0.9902, L3): includes mianserin-specific comparative studies from the 1980s to 1990s.
- Agoraphobia (0.9940, L4): the only retrieved paper concerns a different drug class.
- Ohdo syndrome and variants, Ohdo-type blepharophimosis-intellectual disability syndrome, Keppen-Lubinsky syndrome and ligneous conjunctivitis (L5): prediction only, with no plausible mechanistic link.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available for benign paroxysmal torticollis of infancy.
For reference, the nearest on-label or adjacent predictions have the following publications:
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 29530157 | 2016 | Systematic review and meta-analysis | J Prim Health Care | Antidepressants versus placebo for depression in primary care (melancholia and neurotic depression) |
| 21527126 | 2011 | Meta-analysis of RCTs | J Clin Psychiatry | Antidepressants as a class are effective for dysthymia (not mianserin-specific) |
| 7032887 | 1981 | Analysis of controlled studies | L’Encephale | Mianserin versus clomipramine showed no statistically significant difference in efficacy; earlier onset of action with mianserin in endogenous depression |
| 7710969 | 1994 | Comparative clinical study | Rom J Neurol Psychiatry | Mianserin versus imipramine in minor depressive disorders (129 patients, 4 weeks) |
| 6805758 | 1982 | Case report | Br Med J | Mianserin-induced agranulocytosis (safety signal) |
Australia Market Information
| ARTG Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| ARTG 14366D | Lumin 10 | Tablet containing mianserin hydrochloride 10 mg | Not stated in the data compiled for this report |
Safety Considerations
- Drug Interactions: The interaction query completed, but the 11 records returned are receptor-binding pharmacology entries (for example 5-HT1B, 5-HT2A, 5-HT2C, 5-HT6, 5-HT7, alpha-1 adrenoceptors, LPA1 and NET). They are not drug-drug interactions, and no interaction severity levels were provided.
- Literature safety signal: A case report describes mianserin-induced agranulocytosis (PMID 6805758). Haematological monitoring is therefore a relevant consideration.
Please refer to the TGA-approved Product Information (PI) for warnings, contraindications and full safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction for benign paroxysmal torticollis of infancy rests on a TxGNN model (deep learning) score alone (0.9949), with no clinical trials, no literature and no plausible mechanistic link to mianserin (Evidence Level L5). The score may reflect similarities the model learned between related diseases, not biological evidence. Treating a paediatric channelopathy-related condition with an antidepressant would need a clear scientific rationale first.
To proceed, the following is needed:
- Mechanism of action data to assess any biological link (for example, to CACNA1A-related pathways)
- Preclinical or mechanistic studies supporting a role in paroxysmal torticollis
- The TGA Product Information, including warnings and contraindications, and the approved indication text for the ARTG entry
- Paediatric safety data, given the target population
- A reconsideration of priorities: dysthymic disorder and neurotic disorder are better-supported research questions, though they overlap with existing depression and anxiety uses and would need mianserin-specific controlled evidence
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.