Effect of MMFS-202-302 on Cognitive Enhancement in Schizophrenia
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ClinicalTrials.gov Identifier: NCT02237235 |
Recruitment Status :
Completed
First Posted : September 11, 2014
Last Update Posted : September 5, 2017
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Tracking Information | ||||
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First Submitted Date ICMJE | September 9, 2014 | |||
First Posted Date ICMJE | September 11, 2014 | |||
Last Update Posted Date | September 5, 2017 | |||
Study Start Date ICMJE | August 2014 | |||
Actual Primary Completion Date | August 2017 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Matrics Consensus Cognitive Battery (MCCB) [ Time Frame: Baseline to Day 63 ] Change from Baseline in MATRICS Consensus Cognitive Battery (MCCB) working memory domain.
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Original Primary Outcome Measures ICMJE |
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).
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Current Secondary Outcome Measures ICMJE |
Overall clinical global impression of severity improvement measured by the Clinical Global Impressions Scale assessment of change (CGI-C) [ Time Frame: Day 63 ] To support the primary endpoint of working memory, the CGI-C will demonstrate clinically relevant improvement of global function.
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Original Secondary Outcome Measures ICMJE |
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).
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Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures |
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).
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Descriptive Information | ||||
Brief Title ICMJE | Effect of MMFS-202-302 on Cognitive Enhancement in Schizophrenia | |||
Official Title ICMJE | Effect of MMFS-202-302 on Cognitive Enhancement in Schizophrenia | |||
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. | |||
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. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
60 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | August 2017 | |||
Actual Primary Completion Date | August 2017 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 60 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02237235 | |||
Other Study ID Numbers ICMJE | STU00098144 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Herbert Meltzer, Northwestern University | |||
Study Sponsor ICMJE | Northwestern University | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Northwestern University | |||
Verification Date | August 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |