Schizophrenia Clinical Trial
Official title:
A Randomised Double Blind Placebo Controlled 12 Week Trial of Methotrexate Added to Treatment As Usual in Early Schizophrenia
The aim of the this study is to evaluate the effectiveness of methotrexate added to treatment as usual on positive and negative symptoms, cognitive and social functioning and quality of life of patients suffering from schizophrenia.
The purpose of the study is to test the prediction that addition of methotrexate to
treatment as usual (TAU) for patients with schizophrenia will result in following outcomes:
- Primary:
- improvement in negative symptoms
- improvement in positive symptoms
- Secondary:
- improvement in social functioning
- improvement in cognitive functions
- acceptability and tolerability of methotrexate added to TAU A total 72
participants (36 participants in intervention group and 36 in control group)
meeting inclusion criteria of the study will be recruited and randomized in study
in two arms. Research assistants and participating psychiatrists will assess
participants for eligibility criteria. After providing detailed information
regarding study by using patient information sheet, written informed consent will
be taken from participants. Trained research assistant will asses participants at
baseline, 2, 4, 6 and 12 weeks.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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