Effect of MMFS-202-302 on Cognitive Enhancement in Schizophrenia

Inclusion Criteria

• All patients must be capable of giving written informed consent.
• Male or female subjects of any race; between 18 to 60 years of age, inclusive.
• No hospitalization other than for evaluation in the past four months
• Resides in a stable living situation, according to the investigator's judgment.
• Diagnosis of schizophrenia or schizoaffective disorder of at least one-year duration, as established by the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (SCID-I), and verified with medical records and/or confirmation of diagnosis by the treating clinician. The illness is in a nonacute phase as determined by the subject's primary treating clinician
• Current psychotropic drug treatment consists of monotherapy with an atypical antipsychotic drug.
• No more than a mild level of extrapyramidal symptoms (EPS) as determined by the Simpson Angus Scale (SAS) total score: ≤ 6
• Not taking anticholinergic medication for EPS
• No evidence of tardive dyskinesia
• Subjects healthy enough to complete a 9-week clinical trial
• Women of childbearing potential must have a negative pregnancy test at screening and baseline, and agree to use adequate protection (i.e. double barrier method) for birth control.
• Able to complete cognition assessments in English
• General intellectual abilities falling broadly within the average estimated intelligence quotient (IQ) > 80, as measured by the Wide Range Achievement Test - 4th Edition (WRAT-IV).

Exclusion Criteria

• Failure to perform screening or baseline examinations
• Hospitalization within 8 weeks before screening, or change of antipsychotic medication or dose within 2 months prior to screening
• Subjects who have participated in another clinical trial with an experimental medication within the past 2 months.
• Patient has had cognitive battery similar to those used in this study within the last 12 months
• Subjects with other Diagnostic and Statistical Manual (DSM-V) Axis I or Axis II primary diagnoses
• Diagnosis of alcohol or substance abuse or dependence within the past 3 months,
• Significant suicide risk as determined by the Columbia Suicide Severity Rating Scale (C-SSRS)
• Subjects who plan to begin a new course of cognitive remediation therapy, or have been receiving cognitive remediation therapy for less than one year. .
• History of myocardial infarction, unstable angina, uncontrolled hypotension or hypertension within 3 months before screening.
• Clinically significant abnormality on screening ECG
• Alanine transaminase (ALT) or aspartate transaminase (AST) > 2.5 times the upper limit of normal (ULN)
• History of stroke, brain tumor, head trauma with loss of consciousness, or other clinically significant neurological condition within 12 months before screening
• Subjects with other uncontrolled medical conditions, in the opinion of the investigator
• Polypharmacy with two or more antipsychotic drugs or mood stabilizers
• Use of benzodiazepines
• Individuals with kidney dysfunction will not be enrolled, as dysfunctional kidneys may have difficulty clearing the magnesium from the body
• Individuals who are currently taking magnesium supplements