Memantine Effects on Sensorimotor Gating and Neurocognition in Schizophrenia

Sponsor
University of California, San Diego (Other)
Overall Status
Completed
CT.gov ID
NCT03860597
Collaborator
(none)
72
1
2
36
2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Supportive Care
Official Title:
Memantine Effects on Sensorimotor Gating and Neurocognition in Schizophrenia
Actual Study Start Date :
Apr 1, 2018
Actual Primary Completion Date :
Mar 31, 2021
Actual Study Completion Date :
Mar 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Memantine

Drug: 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.

Placebo Comparator: Placebo

Drug: Placebos
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.

Outcome Measures

Primary Outcome Measures

  1. prepulse inhibition (PPI) [7 and 14 days post baseline]

    Change from placebo measure in PPI

  2. mismatch negativity (MMN) [7 and 14 days post baseline]

    Change from placebo measure in MMN

  3. gamma auditory steady-state response (ASSR) [7 and 14 days post baseline]

    Change from placebo measure in ASSR

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinical Teaching Facility (CTF-B102) at UCSD Medical Center San Diego California United States 92103

Sponsors and Collaborators

  • University of California, San Diego

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Neal R. Swerdlow, M.D., Ph.D., Principal Investigator, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT03860597
Other Study ID Numbers:
  • R01MH094320
First Posted:
Mar 4, 2019
Last Update Posted:
Aug 2, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 2, 2022