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The benefit of minocycline on negative symptoms in early-phase psychosis in addition to standard care - extent and mechanism (BeneMin): study protocol for a randomised controlled trial.


Type

Article

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Authors

Lisiecka, DM 
Barnes, TR 
Chaudhry, IB 
Dazzan, P 

Abstract

Negative symptoms of psychosis do not respond to the traditional therapy with first- or second-generation antipsychotics and are among main causes of a decrease in quality of life observed in individuals suffering from the disorder. Minocycline, a broad-spectrum tetracyclic antibiotic displaying neuroprotective properties has been suggested as a new potential therapy for negative symptoms. In the two previous clinical trials comparing minocycline and placebo, both added to the standard care, patients receiving minocycline showed increased reduction in negative symptoms. Three routes to neuroprotection by minocycline have been identified: neuroprotection against grey matter loss, anti-inflammatory action and stabilisation of glutamate receptors. However, it is not yet certain what the extent of the benefit of minocycline in psychosis is and what its mechanism is. We present a protocol for a multi-centre double-blind randomised placebo-controlled clinical trial entitled The Benefit of Minocycline on Negative Symptoms of Psychosis: Extent and Mechanism (BeneMin).

Description

Keywords

Minocycline, Psychosis, Negative symptoms, Neuroprotection, Double-blind randomised placebo-controlled clinical trial, Multi-centre study, Medication efficacy, Mechanism of action, Blood cytokines screening, Magnetic resonance imaging

Journal Title

Trials

Conference Name

Journal ISSN

1745-6215
1745-6215

Volume Title

16

Publisher

Springer Science and Business Media LLC
Sponsorship
The project is funded by the Efficacy and Mechanisms Evaluation (EME) Programme, an MRC and NIHR partnership (–grant number 09/100/23). EMJ is supported by the National Institute for Health Research University College London Hospitals Biomedical Research Centre. Minocycline and placebo are manufactured, controlled and distributed to the Trusts’ pharmacies by Catalent, UK.