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 unipolar depression, endogenous depression, major depressive disorder and anxiety disorder. The TxGNN model’s top-ranked prediction is benign paroxysmal torticollis of infancy, but this is a model prediction only, with 0 clinical trials and 0 publications behind it. Among the other predicted indications, neurotic disorder has the most mianserin-specific literature (4 publications), and dysthymic disorder, melancholia and neurotic depression are close to the approved depression uses.
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 (for the top-ranked indication) |
| India Market Status | Listed in a compiled Indian medicine price dataset (4 of 4) – CDSCO approval status is not included in this data |
| Number of Listed Products | 4 (valid: 4) |
| Recommended Decision | Hold |
Other predicted indications, for comparison:
| Rank | Predicted Indication | TxGNN Score | Evidence Level | Registered Trials | Publications |
|---|---|---|---|---|---|
| 1 | Benign paroxysmal torticollis of infancy | 0.9949 | L5 | 0 | 0 |
| 3 | Agoraphobia | 0.9940 | L5 | 0 | 1 |
| 4 | Ohdo syndrome and variants | 0.9923 | L5 | 0 | 0 |
| 7 | Neurotic disorder | 0.9902 | L5 | 0 | 4 |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available in the compiled data. Based on known pharmacology, mianserin is a tetracyclic antidepressant. Its receptor profile includes 5-HT1B, 5-HT2A/2B/2C, 5-HT6 and 5-HT7 serotonin receptors, α1A/1B/1D-adrenoceptors, the LPA1 receptor and the noradrenaline transporter (NET). Its efficacy in depression is established and it has been marketed for many years.
The top-ranked prediction, benign paroxysmal torticollis of infancy, has no established mechanistic link. It is a rare paediatric condition often associated with channelopathy-related genetic variants (such as CACNA1A). There is no evidence that mianserin’s receptor activity addresses its pathophysiology, and paediatric use would raise additional safety concerns. The high score comes from the TxGNN model (deep learning) and may reflect similarities the model learned between related diseases, not biological evidence. Ohdo syndrome (a rare genetic developmental disorder) is in the same position.
The more credible candidates are mood and anxiety conditions:
- Dysthymic disorder, melancholia and neurotic depression are chronic, severe or milder forms of depression, closely related to mianserin’s approved uses. Melancholia in particular is effectively on-label or near on-label, so it is not a true repurposing case.
- Neurotic disorder is a broad legacy category covering anxiety and depressive conditions and overlaps with mianserin’s approved depression and anxiety indications.
- Agoraphobia is an anxiety-spectrum disorder, so there is some conceptual overlap, but the only retrieved paper concerns a different drug class.
Clinical Trial Evidence
Currently no related clinical trials registered for any of the predicted indications.
Literature Evidence
No literature is available for benign paroxysmal torticollis of infancy or Ohdo syndrome. The tables below show the most relevant papers for the other indications. Most are class-level antidepressant reviews and do not isolate mianserin.
Neurotic disorder (most mianserin-specific literature)
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 8722245 | 1996 | Clinical study | Psychiatria Polska | 50 depressed patients (including 4 with neurotic depression) treated with mianserin monotherapy, rated on the Hamilton scale at days 7, 14 and 28 |
| 7710969 | 1994 | Comparative study | Rom J Neurol Psychiatry | Mianserin vs imipramine in minor depressive disorders; about 40% of patients were discharged as clearly improved after 4 weeks |
| 7032887 | 1981 | Analysis of controlled studies | L’Encephale | Three controlled studies of mianserin vs clomipramine showed no significant efficacy difference; mianserin had an earlier onset in endogenous depression |
| 11063152 | 2000 | Cohort / predictive study | Scand J Gastroenterol | Personality traits and response to mianserin or placebo in functional GI disorder (tangential relevance) |
Neurotic depression / melancholia (selected)
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 29530157 | 2016 | Systematic review / meta-analysis | J Prim Health Care | Antidepressants versus placebo in primary care depression |
| 40183137 | 2025 | Network meta-analysis | Br J Psychiatry | Antidepressant efficacy and tolerability in depression with physical comorbidity |
| 25911132 | 2015 | Systematic review | J Affect Disord | Evidence-based dose equivalents of antidepressants from RCTs |
| 22244025 | 2011 | Meta-analysis | J Clin Psychiatry | Antidepressant efficacy in late-life depression |
| 6824555 | 1983 | Double-blind trial | Br J Clin Pharmacol | Mianserin vs doxepin in outpatient depression with anxiety; both improved, with no consistent efficacy difference |
| 2864794 | 1985 | Double-blind multicentre trial | Acta Psychiatr Scand Suppl | Mianserin vs nomifensine in 61 depressed patients |
| 1454971 | 1992 | Double-blind placebo-controlled trial | Psychother Psychosom | Mianserin in chronic idiopathic pain and “masked” depression |
| 3863468 | 1985 | Open pilot study | Acta Psychiatr Scand Suppl | 110 depressed children and adolescents treated with mianserin (about 1 mg/kg/day) for 60 days |
| 7048075 | 1982 | Review | Mod Probl Pharmacopsychiatry | Mianserin overview |
Dysthymic disorder and agoraphobia
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 21527126 | 2011 | Meta-analysis | J Clin Psychiatry | Antidepressants in dysthymia, placebo-controlled RCTs (class-level; mianserin not isolated) |
| 7717094 | 1995 | Review | Acta Psychiatr Scand Suppl | Reversible MAO-A inhibitors in mental disorders (does not address mianserin directly) |
India Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 69375 | Depnon 30mg Tablet | Strip of 10 tablets | Not specified in the compiled data |
| 64260 | Depnon 10mg Tablet | Strip of 10 tablets | Not specified in the compiled data |
| 225409 | Tetradep 10mg Tablet | Strip of 10 tablets | Not specified in the compiled data |
| 226232 | Tetradep 20mg Tablet | Strip of 10 tablets | Not specified in the compiled data |
All four registrations are valid single-ingredient oral tablets. Depnon is made by Infar India Ltd and Tetradep by Torrent Pharmaceuticals Ltd.
Safety Considerations
Package insert warnings and contraindications were not available in the compiled data. Please refer to the package insert for safety information.
The receptor-binding data compiled for this report list 11 pharmacological targets (serotonin receptors, α1-adrenoceptors, LPA1 and NET). These are binding targets rather than documented drug-drug interactions, so they do not show specific interacting drugs.
Literature points to some context-specific concerns that need verification against the label: antidepressant safety in overdose, interactions with antiepileptic drugs in patients with epilepsy (PMID 36278185, 7207339), cardiovascular effects of antidepressants (PMID 2690161), and suicidality in depression (PMID 9616807). Paediatric use, relevant to the top-ranked prediction, would need particular care.
Conclusion and Next Steps
Decision: Hold
Rationale: The top-ranked prediction (benign paroxysmal torticollis of infancy) has a high model score but no trials, literature or plausible mechanism, and it involves a paediatric population. The better-supported candidates (neurotic disorder, dysthymic disorder, melancholia, neurotic depression) are close to existing depression and anxiety indications, so they offer little true repurposing novelty. Their evidence consists mainly of older comparative studies and class-level reviews rather than mianserin-specific Phase 3 trials.
To proceed, the following is needed:
- Package insert warnings and contraindications from the India regulatory source (currently a blocking gap for safety screening)
- Mechanism of action data for mianserin
- Review of the study designs of the four neurotic disorder papers to confirm the evidence level
- Any mianserin-specific controlled trials in dysthymia or other chronic mild depression
- Confirmation of the approved indication text for the four India registrations
- For the paediatric candidate, a specific mechanistic hypothesis and a paediatric safety assessment before any further work
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.