- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03860597
Memantine Effects on Sensorimotor Gating and Neurocognition in Schizophrenia
December 1, 2022 updated by: Neal R. Swerdlow, M.D., Ph.D., University of California, San Diego
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Diego, California, United States, 92103
- Clinical Teaching Facility (CTF-B102) at UCSD Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 48 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
To assess the acute effects of MEM (0 vs. 20 mg) on measures of auditory processing fidelity, auditory learning and EAIP, in AP-medicated adult SZ patients and HS.
|
Active Comparator: Memantine
|
To assess the acute effects of MEM (0 vs. 20 mg) on measures of auditory processing fidelity, auditory learning and EAIP, in AP-medicated adult SZ patients and HS.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prepulse Inhibition (PPI)
Time Frame: 7 and 14 days post baseline
|
PPI of the startle reflex is the automatic reduction in startle magnitude (assessed by EMG of orbicularis oculi) when a startling stimulus (40 ms 118 dB(A) noise burst; "PULSE") is preceded (10-120 msec) by a weak stimulus (here a 20 msec burst 16 dB over background "PREPULSE").
A %PPI metric is calculated based on the relative startle magnitude on (PREPULSE + PULSE) trials vs. PULSE alone trials.
Possible maximal inhibition is 100%; there is no maximal "negative" value of inhibition.
There is no clear "advantage" or "disadvantage" for lower or higher %PPI values, though on average, schizophrenia patients demonstrate lower % values compared to matched healthy subjects.
Day 1 was baseline testing: testing occurred, data was collected, but no "intervention" was given.
There were two possible "interventions": active (MEM 20 mg po) and placebo.
One intervention was given on day 7 post baseline, the other intervention was given on day 14 post baseline, with order of intervention balanced.
|
7 and 14 days post baseline
|
Mismatch Negativity (MMN); Unit of Measure of MMN is Microvolts.
Time Frame: 7 and 14 days post baseline
|
85 dB SPL stimuli were presented via Etymotic ER3-A insert earphones.
A 4-tone auditory oddball paradigm with 82% standards & 18% deviant stimuli, differed from standard in pitch, duration, or both.
A pseudorandomized sequence produced a minimum of 3 standard tones between each deviant stimulus.
All tones had 5-ms rise/fall times presented with a fixed 500-ms stimulus onset asynchrony.
Subjects viewed a silent movie & instructed to ignore auditory stimuli.
EEG were continuously recorded at a sampling rate of 2048-Hz from 64 channels, using BioSemi ActiveTwo system & downsampled to 512-Hz.
Deviant-minus-standard difference waves were generated for each deviant type & low-pass filtered (20-Hz zerophase shift, 24 dB/octave rolloff).
MMN was computed as mean amplitude across 135-205 ms range for each deviant type in difference waveforms at electrode Fz.
Data were analyzed by RM-ANOVA, with diagnosis as a between-subject factor, & drug condition (placebo vs MEM) as a within-subject factor.
|
7 and 14 days post baseline
|
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".
Time Frame: 7 and 14 days post baseline
|
1 ms, 85 dB clicks were presented in 500 ms trains at a frequency of 40 Hz; 250 click trains were played (inter-train interval=0.5 s).
EEG was continuously recorded with 64-channel BioSemi ActiveTwo system (sampling rate=2048 Hz).
Data processed offline via Matlab, EEGlab, & BrainVision Analyzer.
Continuous data were segmented relative to stimulus onset (-100 ms to 500 ms) & each epoch was baseline-corrected relative to 100 ms pre-stimulus interval.
γEP was assessed based on first 100 artifact-free epochs at Fz. Averaged epochs across click trains were transformed into power spectrum via fast Fourier transform using a bin width of 2 Hz.
40 Hz power spectrum was averaged across 4 Hz band from 38-42 Hz.
Data were analyzed by RM-ANOVA, with diagnosis as a between- & drug condition (placebo vs MEM) as a within-subject factor.
Analyses revealed robust & time bin-independent effects of diagnosis & drug across 200-500 ms window & thus this interval was the focus of all subsequent analyses.
|
7 and 14 days post baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2018
Primary Completion (Actual)
March 31, 2021
Study Completion (Actual)
March 31, 2021
Study Registration Dates
First Submitted
February 28, 2019
First Submitted That Met QC Criteria
February 28, 2019
First Posted (Actual)
March 4, 2019
Study Record Updates
Last Update Posted (Actual)
December 21, 2022
Last Update Submitted That Met QC Criteria
December 1, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Schizophrenia Spectrum and Other Psychotic Disorders
- Schizophrenia
- Disease
- Psychotic Disorders
- Mood Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Dopamine Agents
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Memantine
Other Study ID Numbers
- R01MH094320 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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