Schizophrenia Clinical Trial
Official title:
A Randomized Double Blind Parallel Trial Administering Methotrexate vs Placebo as add-on to Antipsychotics in Patients With Schizophrenia or Schizoaffecive Disorder
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.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | January 1, 2020 |
Est. primary completion date | January 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 35 Years |
Eligibility |
Inclusion Criteria: 1. Male or female, 18-35 years of age, inclusive 2. 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]). 3. Willing and able to provide informed consent, after the nature of the study has been fully explained. 4. Current DSM-IV-TR diagnosis of schizophrenia or schizoaffective disorder as confirmed by modified SCID. 5. Within the first five years of diagnosis. 6. 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. 7. Receiving only one anti-psychotic within PORT dosages 8. Inpatients or outpatients. Inpatients will be randomized 3 days or more after admission Exclusion Criteria: 1. Unwilling or unable, in the opinion of the Investigator, to comply with study instructions 2. Evidence of significant liver disease. Patients with LFT above normal will be excluded. 3. Pregnant or breast-feeding 4. 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) 5. At significant risk of committing suicide, or in the opinion of the Investigator, currently is at imminent risk of suicide or harming others. 6. 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. 7. Concurrent delirium, mental retardation, drug-induced psychosis, or history of clinically significant brain trauma documented by CT or MRI. 8. Lactose intolerance 9. Immune system disorder or serious infection 10. Patients taking Clozapine |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sheba Medical Center |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PANSS (Positive and Negative Syndrome Scale) Positive Subscale Score at the end of the trial | The positive score subscale has a minimum score of 7 and a maximum score of 49, 7 showing no symptomatology, and 49 showing very severe symptomatology | Changes throughout 16 weeks | |
Secondary | PANSS (Positive and Negative Syndrome Scale) Total score at the end of the trial | The PANSS scale has a minimum score of 30 and a maximum score of 210, 30 showing no symptomatology, and 210 showing very severe symptomatology | Changes throughout 16 weeks | |
Secondary | PANSS (Positive and Negative Syndrome Scale) Negative Susbcale Score at the end of the trial | The negative score subscale has a minimum score of 7 and a maximum score of 49, 7 showing no symptomatology, and 49 showing very severe symptomatology | Changes throughout 16 weeks | |
Secondary | PANSS (Positive and Negative Syndrome Scale) General Psychopathology Subscale Score at the end of the trial | The general psychopathology subscale score has a minimum score of 16 and a maximum score of 112, 16 showing no symptomatology, and 112 showing very severe symptomatology | Changes throughout 16 weeks | |
Secondary | Clinical Global Impression Scale- Severity (CGI-S) at the end of the trial | This is a clinical scale with a minimum score of 1 (not ill) and a maximum score of 7 (among the most extremely ill patients) | Changes throughout 16 weeks | |
Secondary | Clinical Global Impression Scale- Improvement (CGI-I) at the end of the trial | This is a clinical scale with a minimum score of 1 (very much improved) and a maximum score of 7 (very much worse) | Changes throughout 16 weeks | |
Secondary | Social Functioning Scale Assessment (PSP) at the end of the trial | This is a social functioning scale with a minimum score of 1 (no functioning) and a maximum score of 100 (excellent functioning) | Changes throughout 16 weeks | |
Secondary | Rates of drop outs before the end of the trial | The number of drop outs from the study will be analysed at the end of the study. | Rates throughout 16 weeks |
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