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

NCT02237235 | Completed Phase 2 Results

• 1 other identifier: STU00098144
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Schizophrenia; Schizoaffective Disorder

Keywords

Schizophrenia; Schizoaffective disorder; Cognition; Magnesium; Imaging; Negative symptoms

Outcome Measures

Primary Outcomes (1)

• MATRICS Consensus Cognitive Battery (MCCB)

  Change from Baseline in MATRICS Consensus Cognitive Battery (MCCB) working memory domain. The MCCB measures cognitive function. The MCCB provides an overall composite score, expressed as a T-score, with a mean of 50 and a standard deviation of 10 The MCCB does not have minimum and maximum scores due to the use of T scores. A typical score will fall within a range of 40-60. Scores below 40 indicate impaired cognitive functioning, while scores above 60 suggest above-average cognitive abilities. The MCCB is often used in clinical research to assess cognitive deficits in individuals with psychiatric disorders, and the T-score scale is used to track cognitive changes over time.

  Baseline to Day 63

Secondary Outcomes (1)

• Overall Clinical Global Impression of Severity Improvement Measured by the Clinical Global Impressions Scale Assessment of Change (CGI-C)

  Day 63

Study Arms (2)

MMFS-202 -302

EXPERIMENTAL

MMFS-202: evening dose MMFS-302: morning dose

Drug: MMFS-202-302

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

MMFS-202-302 DRUG

Active ingredient: L-Threonic acid Magnesium salt. 1 g (2 pills) by mouth once daily in the evening for 9 weeks Drug: MMFS-302 Active ingredient: L-Threonic Acid Magnesium Salt 1 g (2 pills) by mouth once daily in the morning for 9 weeks

MMFS-202 -302

Placebo DRUG

Two tablets by mouth in the morning, and two tablets by mouth in the evening, daily for 9 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Northwestern University: lead
• Neurocentria, Inc.: collaborator
• Brain & Behavior Research Foundation: collaborator

Study Sites (1)

Northwestern University Psychiatric Clinical Research Program

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Herbert Y. meltzer
• Organization: Northwestern University

h-meltzer@northwestern.edu

312-503-0309

Study Officials

• Herbert Y Meltzer, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2014
• First Posted: September 11, 2014
• Study Start: August 1, 2014
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: June 22, 2025
• Results First Posted: June 22, 2025

Record last verified: 2025-06

Locations

US (1)