Status:
COMPLETED
Effect of MMFS-202-302 on Cognitive Enhancement in Schizophrenia
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
Neurocentria, Inc.
Brain & Behavior Research Foundation
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
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 s...
Detailed Description
One of the symptoms of schizophrenia is a problem with specific domains of cognition, even when the positive symptoms have been treated. The primary goal of this study is to determine the effectivenes...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2017
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02237235
Start Date
August 1 2014
End Date
August 1 2017
Last Update
June 22 2025
Active Locations (1)
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1
Northwestern University Psychiatric Clinical Research Program
Chicago, Illinois, United States, 60611