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Memantine Augmentation of Targeted Cognitive Training in Schizophrenia

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ClinicalTrials.gov Identifier: NCT04857983
Recruitment Status : Recruiting
First Posted : April 23, 2021
Last Update Posted : March 24, 2023
Sponsor:
Information provided by (Responsible Party):
Gregory Light, University of California, San Diego

Study Description
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Brief Summary:
Treatment of schizophrenia currently includes antipsychotic medications and cognitive therapies which improve some symptoms, but do not sufficiently restore cognitive functioning or reduce psychosocial disability. We hypothesize that medications that specifically target sensory information processing deficits, rather than psychotic symptoms per se, will significantly enhance the benefits of a sensory-based targeted cognitive training (TCT) intervention in patients with schizophrenia. We will complete a randomized, double-blind clinical trial to: 1) confirm that the drug memantine augments TCT learning; 2) determine whether memantine enhances the clinical benefits from a full 30 session course of TCT vs. TCT plus placebo in antipsychotic- medicated schizophrenia patients, and 3) determine if memantine's enhancement of TCT is most effective in biomarker-defined subgroups of patients.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Drug: Memantine Drug: Placebo Phase 2 Phase 3

Detailed Description:
Treatment of schizophrenia (SZ) currently includes antipsychotic medications and cognitive therapies which improve some symptoms, but do not sufficiently restore cognitive functioning or reduce psychosocial disability. We propose and will test a novel "augmentation strategy" for using medications to specifically enhance the benefits of targeted cognitive training (TCT) in schizophrenia. This project tests a rational and empirically supported platform for augmenting the benefits of TCT in antipsychotic medicated SZ patients by adjunctive daily treatment of 20 mg memantine, an FDA approved medication for the treatment of cognitive dysfunction in Alzheimer's Disease. We hypothesize that medications that specifically target sensory information processing deficits, rather than psychotic symptoms per se, will significantly enhance the benefits of a sensory-based targeted cognitive training (TCT) intervention in patients with schizophrenia. We will complete a randomized, double-blind clinical trial to: 1) confirm that the drug memantine augments TCT learning; 2) determine whether memantine enhances the clinical benefits from a full 30 session course of TCT vs. TCT plus placebo in antipsychotic- medicated schizophrenia patients, and 3) determine if memantine's enhancement of TCT is most effective in biomarker-defined subgroups of patients.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be randomized to targeted cognitive training (TCT) and memantine (MEM) or targeted cognitive training (TCT) and placebo (PBO)
Masking: Double (Participant, Investigator)
Masking Description: Subjects will be randomized to TCT and memantine or TCT and placebo. The research will be provided with a randomization scheme to follow and will dispense the pills identified only by a code.
Primary Purpose: Treatment
Official Title: Memantine Augmentation of Targeted Cognitive Training in Schizophrenia
Actual Study Start Date : July 6, 2021
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: TCT + PBO
Suppressing active psychosis with antipsychotics benefits cognitive interventions for schizophrenia, but it is possible that drugs with pro-cognitive effects will specifically, and perhaps synergistically, augment the clinical benefits of cognitive therapies. A "proof of concept" for this approach is found in the use of the pro-extinction drugs to selectively enhance the impact of cognitive therapy for anxiety disorders. In this "proof of concept", a learning-based therapy is paired with a medication that enhances a brain mechanism (extinction) that is both 1) critical to that form of learning, and 2) known to be deficient in some anxiety disorders.
 Drug: Placebo
Subjects will be assigned to take memantine or placebo and will complete 30 hours of targeted cognitive training in order to assess whether memantine enhances cognitive training performance
Other Name: targeted cognitive training (TCT)
Active Comparator: TCT + MEM
Suppressing active psychosis with antipsychotics benefits cognitive interventions for schizophrenia, but it is possible that drugs with pro-cognitive effects will specifically, and perhaps synergistically, augment the clinical benefits of cognitive therapies. A "proof of concept" for this approach is found in the use of the pro-extinction drugs to selectively enhance the impact of cognitive therapy for anxiety disorders. In this "proof of concept", a learning-based therapy is paired with a medication that enhances a brain mechanism (extinction) that is both 1) critical to that form of learning, and 2) known to be deficient in some anxiety disorders.
 Drug: Memantine
Subjects will be assigned to take memantine or placebo and will complete 30 hours of targeted cognitive training in order to assess whether memantine enhances cognitive training performance
Other Name: targeted cognitive training (TCT)


Outcome Measures
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Primary Outcome Measures :
  1. Sound Sweeps and perceptual learning [ Time Frame: 25 weeks ]
    Change from baseline TCT performance

  2. MCCB cognitive test performance [ Time Frame: 25 weeks ]
    Change from baseline MCCB performance

  3. Clinical symptoms [ Time Frame: 25 weeks ]
    Change from baseline clinical symptoms


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • DSM-IV diagnosis of schizophrenia or schizoaffective disorder
  • Written informed consent to participate in the study
  • Age 18-65
  • Absence of dementia or mental retardation
  • Urine toxicology negative for recreational drugs
  • Fluent and literate in English

Exclusion Criteria:

  • Meets DSM-IV criteria for current substance abuse or dependence and has been substance abstinent for less than 30 days
  • A history of traumatic brain injury
  • Auditory or visual impairments severe enough to prevent study participation
  • Under conservatorship (determined by Anasazi)
  • Pregnancy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04857983


Contacts
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Contact: Gregory A Light, Ph.D. 619-543-2496 glight@health.ucsd.edu
Contact: Joyce Sprock, B.A. 619-471-9455 jsprock@health.ucsd.edu

Locations
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United States, California
Clinical Teaching Facility (CTF B-403 at UCSD Medical Center) Recruiting
San Diego, California, United States, 92103
Contact: Joyce Sprock, B.A.    619-543-7201    EEGstudy@health.ucsd.edu   
Sponsors and Collaborators
University of California, San Diego
More Information
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Responsible Party: Gregory Light, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT04857983    
Other Study ID Numbers: 201502
First Posted: April 23, 2021    Key Record Dates
Last Update Posted: March 24, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data with other researchers

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Gregory Light, University of California, San Diego:
schizophrenia
cognitive training
EEG
Additional relevant MeSH terms:
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Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Memantine
Antiparkinson Agents
Anti-Dyskinesia Agents
 Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents