Moclobemide

Evidence Level: L2 Predicted Indications: 2

Table of Contents

  1. Moclobemide
  2. Moclobemide: From Depression to Agoraphobia
    1. One-Sentence Summary
    2. Quick Overview
    3. Why is This Prediction Reasonable?
    4. Clinical Trial Evidence
    5. Literature Evidence
    6. South Africa Market Information
    7. Safety Considerations
    8. Conclusion and Next Steps
    9. Disclaimer

## Pharmacist Assessment Report

Moclobemide: From Depression to Agoraphobia

One-Sentence Summary

Moclobemide is a reversible inhibitor of monoamine oxidase A (RIMA), described in the literature as an antidepressant. The TxGNN model predicts it may be effective for agoraphobia, which usually occurs with panic disorder. Support consists of 2 published RCTs among 10 listed publications, with no registered clinical trials.


Quick Overview

Item Content
Original Indication Not recorded in the SAHPRA registration data. Depression is taken from the literature (PMID 7717094).
Predicted New Indication Agoraphobia
TxGNN Prediction Score 99.43%
Evidence Level L2
South Africa Market Status Marketed (see the registration caveat below)
Number of SAHPRA Registrations 1
Recommended Decision Hold

Why is This Prediction Reasonable?

Moclobemide selectively and reversibly inhibits MAO-A, which raises serotonin, norepinephrine and dopamine levels. Its antidepressant activity is well documented. The review by Priest et al. (1995) cites four placebo-controlled double-blind trials in serious depressive illness.

Agoraphobia is rarely studied on its own. It usually occurs with panic disorder, and most published work on moclobemide is in panic disorder with or without agoraphobia. Older reviews report that MAO inhibitors as a class have shown benefit in controlled studies of panic disorder with agoraphobia and social phobia. Reversible MAO-A inhibitors such as moclobemide are described as needing fewer dietary restrictions and having fewer drug interactions than irreversible MAOIs. The link between depression and anxiety disorders is therefore pharmacologically plausible.

Detailed mechanism-of-action data are not available in the source record. The mechanistic reasoning above comes from the literature, not from the drug’s source record.


Clinical Trial Evidence

Currently no related clinical trials registered.


Literature Evidence

PMID Year Type Journal Key Findings
10448444 1999 RCT Br J Psychiatry Placebo-controlled trial of moclobemide, cognitive-behavioural therapy (CBT) and their combination in panic disorder with agoraphobia. The provided abstract does not include results.
10361962 1999 RCT Eur Arch Psychiatry Clin Neurosci Double-blind trial of moclobemide 450 mg/day vs clomipramine 150 mg/day in panic disorder with or without agoraphobia (135 patients randomised). The provided excerpt does not include results.
7954487 1994 Open-label pilot Clin Neuropharmacol 35 outpatients with social phobia received moclobemide 300–600 mg/day for 12 weeks. Fear and avoidance improved consistently, and tolerability was good.
16850261 2006 Imaging study Metab Brain Dis SPECT comparison of citalopram and moclobemide effects on resting brain perfusion in social anxiety disorder. This is indirect evidence for agoraphobia.
28867934 2017 Review Dialogues Clin Neurosci Guideline-based treatment recommendations for anxiety disorders, including panic disorder/agoraphobia.
32002937 2020 Review Adv Exp Med Biol Psychopharmacological treatment recommendations for anxiety disorders, including panic disorder/agoraphobia, based on guidelines and meta-analyses.
7717094 1995 Review Acta Psychiatr Scand Suppl Reviews RIMAs, including moclobemide. Moclobemide showed clear antidepressant activity in 4 placebo-controlled double-blind trials.
2248064 1990 Review Acta Psychiatr Scand Suppl MAOIs as a class were effective in controlled studies of panic disorder with agoraphobia and social phobia.
8313401 1993 Review Clin Neuropharmacol Discusses reversible MAO-A inhibitors in panic disorder. The trial described in the abstract compared brofaromine, not moclobemide, with clomipramine.
7892341 1995 Case report Psychiatr Prax One patient with treatment-refractory panic disorder, including agoraphobia, remitted on imipramine plus moclobemide plus behavioural therapy.

South Africa Market Information

Registration Number Product Name Dosage Form Approved Indication
Reg. No. 35/1.2/0251 Medpro-Ciprofloxacin 750 Tablet (oral) Not stated in the record

Caveat: the only registration linked to this drug is named “Medpro-Ciprofloxacin 750”. Ciprofloxacin is an antibiotic, not moclobemide, so this may be a mapping error. The Marketed status and the registration count of 1 should therefore not be relied on until the registration is verified against SAHPRA records. Essential Medicines List status could not be determined from the available data.


Safety Considerations

Please refer to the SAHPRA-approved Professional Information (PI) for safety information. Report adverse drug reactions to SAHPRA.


Conclusion and Next Steps

Decision: Hold

Rationale: Two published RCTs in panic disorder with or without agoraphobia give this prediction real literature support, and the mechanism is plausible. However, safety information from the SAHPRA PI is missing, which blocks safety screening, and the local registration record appears to be mismatched. No trials are registered specifically for agoraphobia.

To proceed, the following is needed:

  • Verify the SAHPRA registration status of moclobemide, since the linked product is ciprofloxacin.
  • Obtain the PI and extract warnings and contraindications.
  • Retrieve full-text results of the two RCTs (PMIDs 10448444 and 10361962).
  • Complete the mechanism-of-action data, for example from DrugBank.

Other predicted indication: benign paroxysmal torticollis of infancy (score 99.30%) has no supporting trials or literature, and no mechanistic rationale is evident. It is likely a graph-propagation artifact, so the decision is Hold at evidence level L5.

This report is for research reference only and does not constitute medical advice. Repurposing candidates require clinical validation before use.

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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