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| Name | Class |
|---|---|
| Neurocentria, Inc. | INDUSTRY |
| Brain & Behavior Research Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MMFS-202 -302 | Experimental | MMFS-202: evening dose MMFS-302: morning dose |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Clinical Global Impression of Severity Improvement Measured by the Clinical Global Impressions Scale Assessment of Change (CGI-C) | To support the primary endpoint of working memory, the Clinical Global Impression Change (CGI-C) will demonstrate the clinically relevant improvement of global function. Minimum is 1 and Maximum is 6. Higher scores means worse outcome. | Day 63 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Herbert Y Meltzer, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Psychiatric Clinical Research Program | Chicago | Illinois | 60611 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | MMFS-202 -302 | MMFS-202: evening dose MMFS-302: morning dose MMFS-202-302: 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 |
| FG001 | Placebo | Placebo Placebo: Two tablets by mouth in the morning, and two tablets by mouth in the evening, daily for 9 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MMFS-202 -302 | MMFS-202: evening dose MMFS-302: morning dose MMFS-202-302: 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline to Day 63 |
|
9 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MMFS-202 -302 | MMFS-202: evening dose MMFS-302: morning dose MMFS-202-302: 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headche | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Herbert Y. meltzer | Northwestern University | 312-503-0309 | h-meltzer@northwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 18, 2017 | Jun 9, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| Placebo | Drug | Two tablets by mouth in the morning, and two tablets by mouth in the evening, daily for 9 weeks. |
|
| Placebo |
Placebo Placebo: Two tablets by mouth in the morning, and two tablets by mouth in the evening, daily for 9 weeks. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Matrics Consensus Cognitive Battery (MCCB) | The Matrics Consensus Cognitive Battery (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 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 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 | Mean | Standard Deviation | units on a scale |
|
| OG001 | Placebo | Placebo Placebo: Two tablets by mouth in the morning, and two tablets by mouth in the evening, daily for 9 weeks. |
|
|
| Secondary | Overall Clinical Global Impression of Severity Improvement Measured by the Clinical Global Impressions Scale Assessment of Change (CGI-C) | To support the primary endpoint of working memory, the Clinical Global Impression Change (CGI-C) will demonstrate the clinically relevant improvement of global function. Minimum is 1 and Maximum is 6. Higher scores means worse outcome. | Posted | Mean | Standard Deviation | score on a scale | Day 63 |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 27 |
| 30 |
| EG001 | Placebo | Placebo Placebo: Two tablets by mouth in the morning, and two tablets by mouth in the evening, daily for 9 weeks. | 0 | 30 | 0 | 30 | 28 | 30 |
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| pannic attack | Psychiatric disorders | Systematic Assessment |
|
| blurred vision | Eye disorders | Systematic Assessment |
|
| Exacerbation of Psychosis | Psychiatric disorders | Systematic Assessment |
|
| Loose Stool | Gastrointestinal disorders | Systematic Assessment |
|
| Cutting Self | Psychiatric disorders | Systematic Assessment |
|
| Stomach ache | Gastrointestinal disorders | Systematic Assessment |
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| Cold symptoms | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Sore throat | General disorders | Systematic Assessment |
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| Hand spasm | Nervous system disorders | Systematic Assessment |
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| High triglycerides | Endocrine disorders | Systematic Assessment |
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| Shortness of breath | Cardiac disorders | Systematic Assessment |
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| Skin Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Flu-like symptoms | Infections and infestations | Systematic Assessment |
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| Chest Pressure | Cardiac disorders | Systematic Assessment |
|
| Diahrrea | Gastrointestinal disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Increase in bowel movements | Gastrointestinal disorders | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| fever | General disorders | Systematic Assessment |
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| Sinus Congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Heartburn | Gastrointestinal disorders | Systematic Assessment |
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| Strained neck | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Hospitalization | General disorders | Systematic Assessment | severe in intensity and unrelated to study medication |
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| Drowsiness | General disorders | Systematic Assessment |
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| Hospitalization due to diabetic ketoacidosis | Endocrine disorders | Non-systematic Assessment |
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| strep throat | Infections and infestations | Systematic Assessment |
|
| Hot flashes, sweating, chills | General disorders | Systematic Assessment |
|
| Dizziness (Light headedness) | Nervous system disorders | Systematic Assessment |
|
| Pink eye | Eye disorders | Systematic Assessment |
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| Nose and chest congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| dry mouth | General disorders | Systematic Assessment |
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| Ingrown toe nail | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| More burping | Gastrointestinal disorders | Systematic Assessment |
|
| Stomach infection | Gastrointestinal disorders | Non-systematic Assessment |
|
| Angioplasty | Cardiac disorders | Non-systematic Assessment |
|
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