Overview
Effect of MMFS-202-302 on Cognitive Enhancement in Schizophrenia
Status:
Completed
Completed
Trial end date:
2017-08-01
2017-08-01
Target enrollment:
0
0
Participant gender:
All
All
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 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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Northwestern UniversityCollaborators:
Brain & Behavior Research Foundation
Neurocentria, Inc
Neurocentria, Inc.
Criteria
Inclusion Criteria:1. All patients must be capable of giving written informed consent.
2. Male or female subjects of any race; between 18 to 60 years of age, inclusive.
3. No hospitalization other than for evaluation in the past four months
4. Resides in a stable living situation, according to the investigator's judgment.
5. Diagnosis of schizophrenia or schizoaffective disorder of at least one-year duration,
as established by the SCID-I, and verified with medical records and/or confirmation of
diagnosis by treating clinician. The illness is in a nonacute phase as determined by
the subject's primary treating clinician
6. Current psychotropic drug treatment consists of monotherapy with an atypical
antipsychotic drug.
7. No more than a mild level of EPS as determined by the Simpson Angus Scale (SAS) total
score: ≤ 6
8. Not taking anticholinergic medication for EPS
9. No evidence of tardive dykinesia
10. Subjects healthy enough to complete a 9-week clinical trial
11. 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.
12. Able to complete cognition assessments in English
13. General intellectual abilities falling broadly within the average estimated IQ > 80,
as measured by the Wide Range Achievement Test - 4th Edition (WRAT-IV).
Exclusion Criteria:
1. Failure to perform screening or baseline examinations
2. Hospitalization within 8 weeks before screening, or change of antipsychotic medication
or dose within 2 months prior to screening
3. Subjects who have participated in another clinical trial with an experimental
medication within the past 2 months.
4. Patient has had cognitive battery similar to those used in this study within the last
12 months
5. Subjects with other DSM-V Axis I or Axis II primary diagnoses
6. Diagnosis of alcohol or substance abuse or dependence within the past 3 months,
7. Significant suicide risk as determined by the Columbia Suicide Severity Rating Scale
(C-SSRS)
8. Subjects who plan to begin a new course of cognitive remediation therapy, or have been
receiving cognitive remediation therapy for less than one year. .
9. History of myocardial infarction, unstable angina, uncontrolled hypotension or
hypertension within 3 months before screening.
10. Clinically significant abnormality on screening ECG
11. Alanine transaminase (ALT) or aspartate transaminase (AST) > 2.5 times the upper limit
of normal (ULN)
12. History of stroke, brain tumor, head trauma with loss of consciousness, or other
clinically significant neurological condition within 12 months before screening
13. Subjects with other uncontrolled medical conditions, in the opinion of the
investigator
14. Polypharmacy with two or more antipsychotic drugs or mood stabilizers
15. Use of benzodiazepines
16. Individuals with kidney dysfunction will not be enrolled, as dysfunctional kidneys may
have difficulty clearing the magnesium from the body
17. Individuals who are currently taking magnesium supplements