Loading clinical trials...
Loading clinical trials...
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.
Age
18 - 35 years
Sex
ALL
Healthy Volunteers
No
Abasi Shaheed Hospital
Karachi, Sindh, Pakistan
Civil hospital Karachi
Karachi, Sindh, Pakistan
Institute of Behavioural Sciences
Karachi, Sindh, Pakistan
Karwn e Hayat
Karachi, Sindh, Pakistan
Start Date
December 1, 2013
Primary Completion Date
July 1, 2015
Completion Date
August 1, 2015
Last Updated
September 22, 2015
92
ACTUAL participants
Methotrexate
DRUG
Lead Sponsor
Pakistan Institute of Living and Learning
Collaborators
NCT07455929
NCT06740383
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions