Summary

Eligibility
for people ages 18-65 (full criteria)
Location
at San Diego, California
Dates
study started
completion around
Principal Investigator
by Gregory Light

Description

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.

Details

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.

Keywords

Schizophrenia, Schizoaffective Disorder, cognitive training, EEG, Psychotic Disorders, Memantine, TCT + PBO, TCT + MEM

Eligibility

You can join if…

Open to people ages 18-65

  • 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

You CAN'T join if...

  • 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

Location

  • Clinical Teaching Facility (CTF B-403 at UCSD Medical Center) accepting new patients
    San Diego California 92103 United States

Lead Scientist at UCSD

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT04857983
Phase
Phase 2/3 research study
Study Type
Interventional
Participants
Expecting 69 study participants
Last Updated