NCT02237235

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Schizophrenia
• Schizoaffective Disorder

Interventions

Type	Name	Description
DRUG	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
DRUG	Placebo	Two tablets by mouth in the morning, and two tablets by mouth in the evening, daily for 9 weeks.

Timeline

• Start date: 2014-08-01
• Primary completion: 2017-08-01
• Completion: 2017-08-01
• First posted: 2014-09-11
• Last updated: 2025-06-22
• Results posted: 2025-06-22

Locations

1 site across 1 country: United States