Add-on Methotrexate for the Treatment of Schizophrenia
Status:
Unknown status
Trial end date:
2020-01-01
Target enrollment:
Participant gender:
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 methotrexate or placebo once a week for a period of three months to 72 patients
(Chaudry, Husain et al. 2015). Results showed improvement both in positive symptoms, as
measured by the Positive symptoms subscale of the Positive and Negative Syndrome Scale
(PANSS), and in total PANSS scores.
The objective of this study is to replicate Chaudry et al.'s study. This proposed study will
randomize schizophrenia or schizoaffective disorder patients to methotrexate or placebo for a
period of four months.
The study will enroll patients with a DSM-IV-TR diagnosis of schizophrenia or schizoaffective
disorder confirmed by the Modified Structured Clinical Interview for Diagnosis (SCID). In
order to be eligible to enter the study, the patient must have a score of 4 (moderately ill)
or greater on the Clinical Global Impression - Severity (CGI-S) scale. In addition, inclusion
criteria reflect patients with moderate or more severity on positive symptoms, hence having a
score of 4 (moderate) or above on two of the following four PANSS items: delusions,
hallucinatory behaviors, conceptual disorganization or suspiciousness/ persecution. Patients
receiving more than one anti-psychotic or depot antipsychotic will be allowed to participate,
and patients receiving anti-cholinergic agents, beta-blockers, anti-depressants,
mood-stabilizers, sedatives, and anti-anxiety agents will be allowed in the study. Because
the clinical status of patients sometimes improves in the days following admission to the
hospital, newly hospitalized patients will have their baseline visit 3 days or more after
being hospitalized.