Related resources
Full-text held externally
- PMID: 25563714
- UKPMCID: 25563714
- DOI: 10.1186/1745-6215-16-9
Search for item elsewhere
University researcher(s)
Academic department(s)
A randomised double-blind placebo-controlled 12- week feasibility trial of methotrexate added to treatment as usual in early schizophrenia: study protocol for a randomised controlled trial.
Chaudhry, Imran B; Husain, Nusrat; Ur Rahman, Raza; Husain, Mohammed Omair; Hamirani, Mohammed M; Kazmi, Ajmal; Baig, Shakeel; Haddad, Peter M; Buch, Maya H; Qureshi, Inti; Mehmood, Nasir; Kiran, Tayyeba; Fu, Bo; Afsar, Salahuddin; Deakin, Bill
Trials. 2015;16(1):9.
Access to files
Full-text and supplementary files are not available from Manchester eScholar. Full-text is available externally using the following links:
Full-text held externally
- PMID: 25563714
- UKPMCID: 25563714
- DOI: 10.1186/1745-6215-16-9
Abstract
BACKGROUND: Methotrexate is a commonly used anti-inflammatory and immunosuppressive drug. There is growing evidence that inflammatory processes are involved in the pathogenesis of schizophrenia. In our recent randomised double-blind placebo-controlled clinical trial in Pakistan and Brazil, the addition of minocycline (antibiotic and anti-inflammatory drug) for 1Â year to treatment as usual reduced negative symptoms and improved some cognitive measures. A meta-analysis of cytokine changes in the peripheral blood has identified IL-2, IFN-gamma, TNF-alpha and soluble IL-2 receptor as trait markers of schizophrenia because their levels were elevated during acute exacerbations and reduced in remission. This suggests immune activation and an inflammatory syndrome in schizophrenia. Based on the evidence of the strong anti-inflammatory properties of methotrexate, we propose that low-dose methotrexate may be an effective therapy in early schizophrenia. METHODS/DESIGN: This is a double-blind placebo-controlled study of methotrexate added to treatment as usual for patients suffering from schizophrenia, schizoaffective disorder, psychosis not otherwise specified or schizophreniform disorder. This will be with 72 patients, 36 in each arm over 3Â months. There will be screening, randomisation and follow-up visits. Full clinical assessments will be carried out at baseline, 2, 4, 8 and 12Â weeks. Social and cognitive assessments will be carried out at baseline and 12Â weeks. Methotrexate will be given at a dose of 10 mgs orally once a week for a 3-month period. DISCUSSION: Evidence suggests inflammatory processes are involved in the pathogenesis of schizophrenia and anti-inflammatory treatments have shown to have some beneficial effects. Methotrexate is a known immunosuppressant and anti-inflammatory drug. The aim of this study is to establish the degree of improvement in positive and negative symptoms, as well as cognitive functioning with the addition of methotrexate to treatment as usual.ClinicalTrials.gov identifier: NCT02074319 (24 February 2014).