Clinical trial NCT04857983: Memantine Augmentation of Targeted Cognitive Training in Schizophrenia
Official title: Memantine Augmentation of Targeted Cognitive Training in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: schizophrenia
cognitive training
EEG
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2021-04-23
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomized to targeted cognitive training (TCT) and memantine (MEM) or targeted cognitive training (TCT) and placebo (PBO)
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Positive & Negative Symptom Scale total (PANSSt)
timeFrame: approximately 25 weeks
measure: World Health Organization Disability Schedule (WHODAS 2.0)
timeFrame: approximately 25 weeks
measure: MATRICS Consensus Cognitive Battery Global Composite T-score (MCCB-C)
timeFrame: approximately 25 weeks
Secondary outcomes:
measure: Positive & Negative Symptom Scale (PANSS) positive and negative symptom subscales
timeFrame: approximately 25 weeks
measure: Individual MATRICS Consensus Cognitive Battery (MCCB) domain T-scores
timeFrame: approximately 25 weeks
measure: Psychotic Symptoms - PSYRATS hallucination subscale
timeFrame: approximately 25 weeks
measure: Manic Symptoms - Young Mania Rating Scale
timeFrame: approximately 25 weeks
measure: Current Depressive Symptoms - PHQ-9
timeFrame: approximately 25 weeks
measure: Suicidal Ideation - C-SSRS
timeFrame: approximately 25 weeks
measure: Treatment satisfaction
timeFrame: approximately 13 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Clinical Teaching Facility (CTF B-403 at UCSD Medical Center)
state: California
Study officials:
References: