Status:
UNKNOWN
Add-on Methotrexate for the Treatment of Schizophrenia
Lead Sponsor:
Sheba Medical Center
Conditions:
Schizophrenia
Eligibility:
All Genders
18-35 years
Phase:
PHASE2
Brief Summary
A recent double-blind placebo-controlled study has tested the effect of methotrexate as an add-on treatment for patients with schizophrenia or schizoaffective disorder, administering 10 mg of methotre...
Detailed Description
OBJECTIVES The objective of the study is to evaluate the efficacy of Methotrexate compared to placebo, as add-on to anti-psychotics in the treatment of patients with schizophrenia or schizoaffective d...
Eligibility Criteria
Inclusion
- Male or female, 18-35 years of age, inclusive
- Females who are abstinent or practicing an established method of birth control (oral contraceptive tablets, hormonal implant device, hormone patch, injectable contraceptive, intrauterine device \[IUD\]).
- Willing and able to provide informed consent, after the nature of the study has been fully explained.
- Current DSM-IV-TR diagnosis of schizophrenia or schizoaffective disorder as confirmed by modified SCID.
- Within the first five years of diagnosis.
- Positive symptoms: 4 (moderate) or above on CGI-S and a score of 4 (moderate) or above on two of the following four PANSS items: delusions, hallucinatory behaviors, conceptual disorganization or suspiciousness/ persecution.
- Receiving only one anti-psychotic within PORT dosages
- Inpatients or outpatients. Inpatients will be randomized 3 days or more after admission
Exclusion
- Unwilling or unable, in the opinion of the Investigator, to comply with study instructions
- Evidence of significant liver disease. Patients with LFT above normal will be excluded.
- Pregnant or breast-feeding
- Unstable medical disease (malignancy, poorly controlled diabetes, active ischemic cardiac disease, or cardiomyopathy, serious pulmonary disease, COPD and other chronic lungs diseases, serious hematological disorder, kidney disease, impaired liver functioning)
- At significant risk of committing suicide, or in the opinion of the Investigator, currently is at imminent risk of suicide or harming others.
- Patients with a current DSM-IV substance or alcohol abuse. Patients with a history of and/or current recreational use of cannabinoids or alcohol, and/or patients who smoke cigarettes can be included.
- Concurrent delirium, mental retardation, drug-induced psychosis, or history of clinically significant brain trauma documented by CT or MRI.
- Lactose intolerance
- Immune system disorder or serious infection
- Patients taking Clozapine
Key Trial Info
Start Date :
December 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2020
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03369795
Start Date
December 15 2017
End Date
January 1 2020
Last Update
December 12 2017
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