Phase 4
N=42
Memantine Effects on Sensorimotor Gating and Neurocognition in Schizophrenia
Schizophrenia · Schizo Affective Disorder · Schizoaffective Disorder · Healthy
Bottom Line
View on ClinicalTrials.gov: NCT03860597 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcome: Primary: Prepulse Inhibition (PPI) — 32.45; 26.85; 14.11; 11.78 % inhibition of startle
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Memantine (Drug); Placebos (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Diego
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Prepulse Inhibition (PPI) |
32.45; 26.85; 14.11; 11.78; 10.11; 20.55 | — |
| PRIMARY Mismatch Negativity (MMN); Unit of Measure of MMN is Microvolts. |
-3.15; -1.60; -3.52; -3.52; -2.44; -1.70 | — |
| PRIMARY Gamma Auditory Steady-state Response (ASSR). The Primary Unit of Measure of Auditory Steady State Response (ASSR) is Gamma Evoked Power (γEP), Expressed as "Microvolts-squared". |
0.08; 0.07; 0.14; 0.14; 0.09; 0.06 | — |
Summary
This application seeks to determine if neurophysiological metrics of memantine (MEM)-enhanced early auditory information processing (EAIP) in schizophrenia (SZ) mediate gains in auditory processing fidelity (APF) and auditory learning.
Eligibility Criteria
Inclusion Criteria
- diagnosis of schizophrenia OR schizoaffective-depressed OR healthy subjects
- ages 18-50 for all subjects
- double barrier contraception for all subjects
- not pregnant for all subjects
Exclusion Criteria
- DSM-IV Axis I or II Diagnosis for for healthy subjects
- MEM or amantadine for patients
- current substance abuse for all subjects
- current recreational drug use for all subjects
- history of other significant medical illness (e.g. cancer, diabetes, heart disease, HIV, seizures) for all subjects
- open head injury or closed head injury with loss of consciousness > 1 min for all subjects
- hearing or visual impairment for all subjects
- pregnancy for all subjects
- dementia for all subjects
- mental retardation for all subjects
Data sourced from ClinicalTrials.gov (NCT03860597). 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.