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Phase 3 N=40 Randomized Double-blind Treatment

Memantine Augmentation of Targeted Cognitive Training in Schizophrenia

Schizophrenia · Schizoaffective Disorder

Enrolled (actual)
40
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Positive & Negative Symptom Scale Total (PANSSt) — 56.77; 54.24; 52.23; 49.29 score on a scale — p=0.004

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Memantine (Drug); Placebo (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of California, San Diego
Primary completion
Mar 2025

Outcome Measures

OutcomeResultp-value
PRIMARY
Positive & Negative Symptom Scale Total (PANSSt)
56.77; 54.24; 52.23; 49.29; 53.00; 48.47 0.004 sig
PRIMARY
World Health Organization Disability Schedule (WHODAS 2.0)
20.31; 23.06; 21.62; 24.94; 18.77; 23.65 0.129
PRIMARY
MATRICS Consensus Cognitive Battery Global Composite T-score (MCCB-C)
36.38; 31.00; 38.46; 33.76; 42.23; 36.29 0.001 sig
SECONDARY
Positive & Negative Symptom Scale (PANSS) - Positive Symptom Subscale
14.08; 13.41; 14.31; 11.29; 14.15; 12.18 0.192
SECONDARY
Positive & Negative Symptom Scale (PANSS) - Negative Symptom Subscale
13.62; 13.65; 12.07; 12.76; 12.08; 11.82 0.016 sig
SECONDARY
Psychotic Symptoms - PSYRATS Hallucination Subscale
12.62; 7.35; 14.92; 6.24; 13.23; 7.18 0.786
SECONDARY
Manic Symptoms - Young Mania Rating Scale
3.38; 2.53; 3.54; 2.53; 4.62; 2.65 0.536
SECONDARY
Current Depressive Symptoms - PHQ-9
6.85; 8.18; 5.69; 6.29; 6.62; 6.65 0.298

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04857983). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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