Memantine Augmentation of Targeted Cognitive Training in Schizophrenia

Schizophrenia Clinical Trial

Official title:

Memantine Augmentation of Targeted Cognitive Training in Schizophrenia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04857983
• Other study ID #: 201502
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: July 6, 2021
• Est. completion date: December 30, 2023

Study information

• Verified date: March 2023
• Source: University of California, San Diego
• Contact: Gregory A Light, Ph.D.
• Phone: 619-543-2496
• Email: glight[@]health.ucsd.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 69
• Est. completion date: December 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Clinical Teaching Facility (CTF B-403 at UCSD Medical Center)	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sound Sweeps and perceptual learning	Change from baseline TCT performance	25 weeks
Primary	MCCB cognitive test performance	Change from baseline MCCB performance	25 weeks
Primary	Clinical symptoms	Change from baseline clinical symptoms	25 weeks