<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02237235</url>
  </required_header>
  <id_info>
    <org_study_id>STU00098144</org_study_id>
    <nct_id>NCT02237235</nct_id>
  </id_info>
  <brief_title>Effect of MMFS-202-302 on Cognitive Enhancement in Schizophrenia</brief_title>
  <official_title>Effect of MMFS-202-302 on Cognitive Enhancement in Schizophrenia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Neurocentria, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Brain &amp; Behavior Research Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Northwestern University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goals of this study are to study MMFS-202-302 in a double blind, randomized,&#xD;
      placebo-controlled 9-week study of its effect on ameliorating cognitive deficits in 60&#xD;
      patients with schizophrenia or schizoaffective disorder with stable levels of positive&#xD;
      symptoms. Secondary end points will include changes in positive and negative symptoms. One&#xD;
      dose of MMFS-202-302 will be studied and compared with placebo as adjunctive treatment to&#xD;
      atypical antipsychotic drug treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      One of the symptoms of schizophrenia is a problem with specific domains of cognition, even&#xD;
      when the positive symptoms have been treated. The primary goal of this study is to determine&#xD;
      the effectiveness of 9 weeks of supplementation with MMFS-202-302 as augmentation of atypical&#xD;
      antipsychotic medication, to improve a critical specific domain of cognitive function, i.e.,&#xD;
      working memory, in patients with schizophrenia or schizoaffective disorder. To support this&#xD;
      primary goal, global function will be assessed with the Clinical Global Impression assessment&#xD;
      of change.&#xD;
&#xD;
      The investigators will also examine the effect of MMFS-202-302 on other domains of cognition&#xD;
      (e.g. attention, executive function, declarative memory, etc.); negative symptoms of&#xD;
      schizophrenia; positive symptoms of schizophrenia; MRI measures of brain structure, resting&#xD;
      state functional connectivity, and function during evaluation of emotional/unemotional and&#xD;
      rewarding/aversive images and anticipation and receipt of reward and punishment, and working&#xD;
      memory; and EEG measurement of network interactivity during learning and memory recollection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">August 2017</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Matrics Consensus Cognitive Battery (MCCB)</measure>
    <time_frame>Baseline to Day 63</time_frame>
    <description>Change from Baseline in MATRICS Consensus Cognitive Battery (MCCB) working memory domain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall clinical global impression of severity improvement measured by the Clinical Global Impressions Scale assessment of change (CGI-C)</measure>
    <time_frame>Day 63</time_frame>
    <description>To support the primary endpoint of working memory, the CGI-C will demonstrate clinically relevant improvement of global function.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change from Baseline in cognition measured by the MATRICS Consensus Cognitive Battery (MCCB) total score</measure>
    <time_frame>Baseline to Day 63</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline in cognition measured by the MATRICS Consensus Cognitive Battery (MCCB) speed of processing domain subscale score</measure>
    <time_frame>Baseline to Day 63</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline in cognition measured by the MATRICS Consensus Cognitive Battery (MCCB) attention/vigilance domain subscale score</measure>
    <time_frame>Baseline to Day 63</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline in cognition measured by the MATRICS Consensus Cognitive Battery (MCCB) verbal learning domain subscale score</measure>
    <time_frame>Baseline to Days 42 and 63</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline in cognition measured by the MATRICS Consensus Cognitive Battery (MCCB) visual learning domain subscale score</measure>
    <time_frame>Baseline to Day 63</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline in cognition measured by the MATRICS Consensus Cognitive Battery (MCCB) reasoning and problem solving domain subscale score</measure>
    <time_frame>Baseline to Day 63</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline in cognition measured by the MATRICS Consensus Cognitive Battery (MCCB) social cognition domain subscale score</measure>
    <time_frame>Baseline to Day 63</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline in cognition measured by the FAS Phonemic Fluency test</measure>
    <time_frame>Baseline to Day 63</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline in cognition measured by the Brown-Peterson's Auditory Consonant Trigrams test</measure>
    <time_frame>Baseline through Day 63</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline in cognitive outcomes among subgroups of subjects with deficits in the respective cognitive domain</measure>
    <time_frame>Baseline to Day 63</time_frame>
    <description>Cognitive outcomes will be reanalyzed, restricted to the subgroup of subjects whose baseline score is at or below median for healthy age-matched norms (T-score of 50 or below) for the respective cognitive outcome of interest. Analogous analyses will be carried out using more conservative cutoffs of one half and one standard deviation below median (T-score of 45 and 40 or below).</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline in cognition measured by the Wisconsin Card Sorting Test</measure>
    <time_frame>Baseline to Day 63</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline in working memory composite score</measure>
    <time_frame>Baseline to Day 63</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline in Negative symptoms measured by the Brief Negative Symptom Scale (BNSS)</measure>
    <time_frame>Baseline to Day 63</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline in Negative symptoms measured by the Positive and Negative Syndrome Scale (PANSS) negative symptom subscale</measure>
    <time_frame>Baseline to Day 63</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline in Negative symptoms measured by the Calgary Depression Scale for Schizophrenia (CDSS)</measure>
    <time_frame>Baseline to Day 63</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline in Positive symptoms measured by the Positive and Negative Syndrome Scale (PANSS) positive symptom subscale</measure>
    <time_frame>Baseline to Days 42 and 63</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Overall clinical global impression of severity improvement measured by the change from Baseline of Clinical Global Impressions Scale assessment of severity (CGI-S)</measure>
    <time_frame>Baseline to Day 63</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline in brain structure and function</measure>
    <time_frame>Baseline to Day 63</time_frame>
    <description>Magnetic Resonance Imaging (MRI) measures of brain structure; resting state functional connectivity; and activation patterns during performance of a working memory paradigm, and of brain reward networks during affective/neutral image appraisal and reward/loss anticipation and outcome (regions of interest: OMPFC, ACC, NAc, VTA).</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline neural activity and connectivity during learning and memory recollection measured by EEG</measure>
    <time_frame>Baseline to Day 63</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline of red blood cell magnesium levels in relation to efficacy outcome measures</measure>
    <time_frame>Baseline to Day 63</time_frame>
    <description>Red blood cell magnesium level will be evaluated as a putative surrogate biomarker of target engagement, as a predictor of efficacy.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of participants with treatment-related adverse events as assessed by CTCAE v4.0</measure>
    <time_frame>Baseline through Day 63, or Early Termination</time_frame>
    <description>To evaluate safety and tolerability of MMFS-202-302 in patients with schizophrenia or schizoaffective disorder maintained on a stable dose of an atypical antipsychotic, each grade of adverse event will be evaluated individually, as well as the total number of all grades of adverse events</description>
  </other_outcome>
  <other_outcome>
    <measure>Responder analyses</measure>
    <time_frame>Baseline to Day 63</time_frame>
    <description>The number of subjects achieving a cutoff of improving at least one half of a standard deviation (T-score change &gt; 5) on the working memory subscale of the MCCB will be compared between the MMFS-202-302 and Placebo groups. Analogous responder analyses will be carried out for other efficacy outcomes.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Schizophrenia</condition>
  <condition>Schizoaffective Disorder</condition>
  <arm_group>
    <arm_group_label>MMFS-202 -302</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MMFS-202: evening dose&#xD;
MMFS-302: morning dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MMFS-202-302</intervention_name>
    <description>Active ingredient: L-Threonic acid Magnesium salt.&#xD;
1 g (2 pills) by mouth once daily in the evening for 9 weeks&#xD;
Drug: MMFS-302 Active ingredient: L-Threonic Acid Magnesium Salt&#xD;
1 g (2 pills) by mouth once daily in the morning for 9 weeks</description>
    <arm_group_label>MMFS-202 -302</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Two tablets by mouth in the morning, and two tablets by mouth in the evening, daily for 9 weeks.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. All patients must be capable of giving written informed consent.&#xD;
&#xD;
          2. Male or female subjects of any race; between 18 to 60 years of age, inclusive.&#xD;
&#xD;
          3. No hospitalization other than for evaluation in the past four months&#xD;
&#xD;
          4. Resides in a stable living situation, according to the investigator's judgment.&#xD;
&#xD;
          5. Diagnosis of schizophrenia or schizoaffective disorder of at least one-year duration,&#xD;
             as established by the SCID-I, and verified with medical records and/or confirmation of&#xD;
             diagnosis by treating clinician. The illness is in a nonacute phase as determined by&#xD;
             the subject's primary treating clinician&#xD;
&#xD;
          6. Current psychotropic drug treatment consists of monotherapy with an atypical&#xD;
             antipsychotic drug.&#xD;
&#xD;
          7. No more than a mild level of EPS as determined by the Simpson Angus Scale (SAS) total&#xD;
             score: ≤ 6&#xD;
&#xD;
          8. Not taking anticholinergic medication for EPS&#xD;
&#xD;
          9. No evidence of tardive dykinesia&#xD;
&#xD;
         10. Subjects healthy enough to complete a 9-week clinical trial&#xD;
&#xD;
         11. Women of childbearing potential must have a negative pregnancy test at screening and&#xD;
             baseline, and agree to use adequate protection (i.e. double barrier method) for birth&#xD;
             control.&#xD;
&#xD;
         12. Able to complete cognition assessments in English&#xD;
&#xD;
         13. General intellectual abilities falling broadly within the average estimated IQ &gt; 80,&#xD;
             as measured by the Wide Range Achievement Test - 4th Edition (WRAT-IV).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Failure to perform screening or baseline examinations&#xD;
&#xD;
          2. Hospitalization within 8 weeks before screening, or change of antipsychotic medication&#xD;
             or dose within 2 months prior to screening&#xD;
&#xD;
          3. Subjects who have participated in another clinical trial with an experimental&#xD;
             medication within the past 2 months.&#xD;
&#xD;
          4. Patient has had cognitive battery similar to those used in this study within the last&#xD;
             12 months&#xD;
&#xD;
          5. Subjects with other DSM-V Axis I or Axis II primary diagnoses&#xD;
&#xD;
          6. Diagnosis of alcohol or substance abuse or dependence within the past 3 months,&#xD;
&#xD;
          7. Significant suicide risk as determined by the Columbia Suicide Severity Rating Scale&#xD;
             (C-SSRS)&#xD;
&#xD;
          8. Subjects who plan to begin a new course of cognitive remediation therapy, or have been&#xD;
             receiving cognitive remediation therapy for less than one year. .&#xD;
&#xD;
          9. History of myocardial infarction, unstable angina, uncontrolled hypotension or&#xD;
             hypertension within 3 months before screening.&#xD;
&#xD;
         10. Clinically significant abnormality on screening ECG&#xD;
&#xD;
         11. Alanine transaminase (ALT) or aspartate transaminase (AST) &gt; 2.5 times the upper limit&#xD;
             of normal (ULN)&#xD;
&#xD;
         12. History of stroke, brain tumor, head trauma with loss of consciousness, or other&#xD;
             clinically significant neurological condition within 12 months before screening&#xD;
&#xD;
         13. Subjects with other uncontrolled medical conditions, in the opinion of the&#xD;
             investigator&#xD;
&#xD;
         14. Polypharmacy with two or more antipsychotic drugs or mood stabilizers&#xD;
&#xD;
         15. Use of benzodiazepines&#xD;
&#xD;
         16. Individuals with kidney dysfunction will not be enrolled, as dysfunctional kidneys may&#xD;
             have difficulty clearing the magnesium from the body&#xD;
&#xD;
         17. Individuals who are currently taking magnesium supplements&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Herbert Y Meltzer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northwestern University Psychiatric Clinical Research Program</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>September 9, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <last_update_submitted>August 31, 2017</last_update_submitted>
  <last_update_submitted_qc>August 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>Herbert Meltzer</investigator_full_name>
    <investigator_title>Professor of Psychiatry, Physiology and Pharmacology</investigator_title>
  </responsible_party>
  <keyword>Schizophrenia</keyword>
  <keyword>Schizoaffective disorder</keyword>
  <keyword>Cognition</keyword>
  <keyword>Magnesium</keyword>
  <keyword>Imaging</keyword>
  <keyword>Negative symptoms</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
    <mesh_term>Psychotic Disorders</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>February 23, 2022</submitted>
    <returned>March 21, 2022</returned>
    <submitted>April 11, 2022</submitted>
    <returned>May 6, 2022</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02237235
org study id: STU00098144
nct id: NCT02237235
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
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 9 weeks of supplementation with MMFS-202-302 as augmentation of atypical
      antipsychotic medication, to improve a critical specific domain of cognitive function, i.e.,
      working memory, in patients with schizophrenia or schizoaffective disorder. To support this
      primary goal, global function will be assessed with the Clinical Global Impression assessment
      of change.

      The investigators will also examine the effect of MMFS-202-302 on other domains of cognition
      (e.g. attention, executive function, declarative memory, etc.); negative symptoms of
      schizophrenia; positive symptoms of schizophrenia; MRI measures of brain structure, resting
      state functional connectivity, and function during evaluation of emotional/unemotional and
      rewarding/aversive images and anticipation and receipt of reward and punishment, and working
      memory; and EEG measurement of network interactivity during learning and memory recollection.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Matrics Consensus Cognitive Battery (MCCB)
time frame: Baseline to Day 63
description: Change from Baseline in MATRICS Consensus Cognitive Battery (MCCB) working memory domain.
measure: Overall clinical global impression of severity improvement measured by the Clinical Global Impressions Scale assessment of change (CGI-C)
time frame: Day 63
description: To support the primary endpoint of working memory, the CGI-C will demonstrate clinically relevant improvement of global function.
measure: Change from Baseline in cognition measured by the MATRICS Consensus Cognitive Battery (MCCB) total score
time frame: Baseline to Day 63
measure: Change from Baseline in cognition measured by the MATRICS Consensus Cognitive Battery (MCCB) speed of processing domain subscale score
time frame: Baseline to Day 63
measure: Change from Baseline in cognition measured by the MATRICS Consensus Cognitive Battery (MCCB) attention/vigilance domain subscale score
time frame: Baseline to Day 63
measure: Change from Baseline in cognition measured by the MATRICS Consensus Cognitive Battery (MCCB) verbal learning domain subscale score
time frame: Baseline to Days 42 and 63
measure: Change from Baseline in cognition measured by the MATRICS Consensus Cognitive Battery (MCCB) visual learning domain subscale score
time frame: Baseline to Day 63
measure: Change from Baseline in cognition measured by the MATRICS Consensus Cognitive Battery (MCCB) reasoning and problem solving domain subscale score
time frame: Baseline to Day 63
measure: Change from Baseline in cognition measured by the MATRICS Consensus Cognitive Battery (MCCB) social cognition domain subscale score
time frame: Baseline to Day 63
measure: Change from Baseline in cognition measured by the FAS Phonemic Fluency test
time frame: Baseline to Day 63
measure: Change from Baseline in cognition measured by the Brown-Peterson's Auditory Consonant Trigrams test
time frame: Baseline through Day 63
measure: Change from Baseline in cognitive outcomes among subgroups of subjects with deficits in the respective cognitive domain
time frame: Baseline to Day 63
description: Cognitive outcomes will be reanalyzed, restricted to the subgroup of subjects whose baseline score is at or below median for healthy age-matched norms (T-score of 50 or below) for the respective cognitive outcome of interest. Analogous analyses will be carried out using more conservative cutoffs of one half and one standard deviation below median (T-score of 45 and 40 or below).
measure: Change from Baseline in cognition measured by the Wisconsin Card Sorting Test
time frame: Baseline to Day 63
measure: Change from Baseline in working memory composite score
time frame: Baseline to Day 63
measure: Change from Baseline in Negative symptoms measured by the Brief Negative Symptom Scale (BNSS)
time frame: Baseline to Day 63
measure: Change from Baseline in Negative symptoms measured by the Positive and Negative Syndrome Scale (PANSS) negative symptom subscale
time frame: Baseline to Day 63
measure: Change from Baseline in Negative symptoms measured by the Calgary Depression Scale for Schizophrenia (CDSS)
time frame: Baseline to Day 63
measure: Change from Baseline in Positive symptoms measured by the Positive and Negative Syndrome Scale (PANSS) positive symptom subscale
time frame: Baseline to Days 42 and 63
measure: Overall clinical global impression of severity improvement measured by the change from Baseline of Clinical Global Impressions Scale assessment of severity (CGI-S)
time frame: Baseline to Day 63
measure: Change from Baseline in brain structure and function
time frame: Baseline to Day 63
description: Magnetic Resonance Imaging (MRI) measures of brain structure; resting state functional connectivity; and activation patterns during performance of a working memory paradigm, and of brain reward networks during affective/neutral image appraisal and reward/loss anticipation and outcome (regions of interest: OMPFC, ACC, NAc, VTA).
measure: Change from Baseline neural activity and connectivity during learning and memory recollection measured by EEG
time frame: Baseline to Day 63
measure: Change from Baseline of red blood cell magnesium levels in relation to efficacy outcome measures
time frame: Baseline to Day 63
description: Red blood cell magnesium level will be evaluated as a putative surrogate biomarker of target engagement, as a predictor of efficacy.
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
time frame: Baseline through Day 63, or Early Termination
description: To evaluate safety and tolerability of MMFS-202-302 in patients with schizophrenia or schizoaffective disorder maintained on a stable dose of an atypical antipsychotic, each grade of adverse event will be evaluated individually, as well as the total number of all grades of adverse events
measure: Responder analyses
time frame: Baseline to Day 63
description: The number of subjects achieving a cutoff of improving at least one half of a standard deviation (T-score change > 5) on the working memory subscale of the MCCB will be compared between the MMFS-202-302 and Placebo groups. Analogous responder analyses will be carried out for other efficacy outcomes.
arm group label: MMFS-202 -302
arm group type: Experimental
description: MMFS-202: evening dose
MMFS-302: morning dose
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo
intervention type: Drug
intervention name: MMFS-202-302
description: 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
arm group label: MMFS-202 -302
intervention type: Drug
intervention name: Placebo
description: Two tablets by mouth in the morning, and two tablets by mouth in the evening, daily for 9 weeks.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Herbert Y Meltzer, MD
role: Principal Investigator
affiliation: Northwestern University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Herbert Meltzer
investigator title: Professor of Psychiatry, Physiology and Pharmacology
mesh term: Schizophrenia
mesh term: Psychotic Disorders
submitted: February 23, 2022
returned: March 21, 2022
submitted: April 11, 2022
returned: May 6, 2022