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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by Northwestern University
Sponsor:
Collaborators:
Neurocentria, Inc
Brain & Behavior Research Foundation
Information provided by (Responsible Party):
Herbert Meltzer, Northwestern University
ClinicalTrials.gov Identifier:
NCT02237235
First received: September 9, 2014
Last updated: January 11, 2017
Last verified: January 2017

September 9, 2014
January 11, 2017
August 2014
March 2018   (Final data collection date for primary outcome measure)
Matrics Consensus Cognitive Battery (MCCB) [ Time Frame: One year ]
The primary outcome measure will be a time x group effect on one or more subscales of the MATRICS Cognitive Consensus Battery (MCCB). The MCCB consists of 9 cognitive tests covering seven domains. This will be augmented by additional neuropsychological measures of verbal fluency (FAS Phonemic Fluency), working memory (Brown-Peterson's Auditory Consonant Trigrams) and executive function (the Wisconsin Card Sorting Test).
Same as current
Complete list of historical versions of study NCT02237235 on ClinicalTrials.gov Archive Site
Negative symptoms [ Time Frame: One year ]
To determine the effect of MMFS-202-302 on negative symptoms of schizophrenia, as measured by the Brief Negative Symptom Scale (BNSS), and imaging of brain reward networks (OMPFC, ACC, NAc, VTA).
Negative symptoms [ Time Frame: One year ]
To determine the effect of MgT on negative symptoms of schizophrenia, as measured by the Brief Negative Symptom Scale (BNSS), and imaging of brain reward networks (OMPFC, ACC, NAc, VTA).
  • Neuroimaging [ Time Frame: One year ]
    To determine the effect of MMFS-202-302 as augmentation of atypical antipsychotic medication on both the behavioral performance and activation patterns in schizophrenia patients during a WM neuroimaging paradigm. Specifically, investigation in whether improvement from baseline task performance occurs for the MMFS-202-302 + APD group, and if this improvement is associated with increases in WM-related brain region activation (DLPFC & PPC).
  • EEG [ Time Frame: One year ]
    To evaluate the effect of MMFS-202-302 on activity and connectivity in the brain using EEG methods
Neuroimaging [ Time Frame: One year ]
4. To determine the effect of MgT as augmentation of atypical antipsychotic medication on both the behavioral performance and activation patterns in schizophrenia patients during a WM neuroimaging paradigm. Specifically, investigation in whether improvement from baseline task performance occurs for the MgT + APD group, and if this improvement is associated with increases in WM-related brain region activation (DLPFC & PPC).
 
Effect of MMFS-202-302 on Cognitive Enhancement in Schizophrenia
Effect of MMFS-202-302 on Cognitive Enhancement in Schizophrenia
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.

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 effectiveness of MMFS-202-302 as augmentation of atypical antipsychotic medication, to improve specific domains of cognitive function, e.g. attention, executive function, declarative memory, etc in patients with schizophrenia or schizoaffective disorder.

The investigators will also examine the effect of MMFS-202-302 on negative symptoms of schizophrenia, positive symptoms of schizophrenia, and working memory as measured by a neuroimaging paradigm.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Schizophrenia
  • Schizoaffective Disorder
  • Drug: MMFS-202-302

    Active ingredient: L-Threonic acid Magnesium salt.

    Inactive ingredients: polyvinyl pyrolidone, microcrystalline cellulose, silicon dioxide, talc, and magnesium stearate.

  • Drug: Placebo
    Inactive ingredients for placebo: talc, magnesium stearate, povidone K-90, colloidal silicon dioxide, microcrystalline cellulose, sodium carboxymethylcellulose, carbopol 974P, starcap 1500.
  • Experimental: MMFS-202-302

    MMFS-202: 1 g/per day (2 pills)

    MMFS-302: 2 g/day (2 pills)

    Intervention: Drug: MMFS-202-302
  • Placebo Comparator: Placebo
    Placebo 4 pills/day
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
March 2018
March 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. All patients must be capable of giving written informed consent.
  2. Male or female subjects of any race; between 18 to 55 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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact: Cale Wardell, BA 312.503.9076 cale.wardell@northwestern.edu
Contact: Marko Mihailovic, MA 312.503.9096 marko.mihailovic@northwestern.edu
United States
 
 
NCT02237235
STU00098144
No
Not Provided
Not Provided
Not Provided
Herbert Meltzer, Northwestern University
Northwestern University
  • Neurocentria, Inc
  • Brain & Behavior Research Foundation
Principal Investigator: Herbert Y Meltzer, MD Northwestern University
Northwestern University
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP