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

Completed · Phase 2 · Has a placebo group

Conditions studied: Schizophrenia, Schizoaffective Disorder

In brief

The goals of this study are to study MMFS-202-302 in a double blind, randomized, placebo-controlled 9-week study of its effect on ameliorating cognitive deficits in 60 patients with schizophrenia or schizoaffective disorder with stable levels of positive symptoms. Secondary end points will include changes in positive and negative symptoms. One dose of MMFS-202-302 will be studied and compared with placebo as adjunctive treatment to atypical antipsychotic drug treatment.

Key facts

Study ID

NCT02237235

Run by

Northwestern University

People needed

60

Starts

2014-08-01

Expected to finish

2017-08-01

Last updated by the study team

2025-06-22

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• Northwestern University Psychiatric Clinical Research Program — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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