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Memantine Effects on Sensorimotor Gating and Neurocognition in Schizophrenia

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ClinicalTrials.gov Identifier: NCT03860597
Recruitment Status : Recruiting
First Posted : March 4, 2019
Last Update Posted : March 4, 2019
Sponsor:
Information provided by (Responsible Party):
Neal R. Swerdlow, M.D., Ph.D., University of California, San Diego

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
Schizophrenia Schizo Affective Disorder Schizoaffective Disorder Healthy Drug: Memantine Drug: Placebos Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 81 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 : April 1, 2018
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

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.




Primary Outcome Measures :
  1. prepulse inhibition (PPI) [ Time Frame: 7 and 14 days post baseline ]
    Change from placebo measure in PPI

  2. mismatch negativity (MMN) [ Time Frame: 7 and 14 days post baseline ]
    Change from placebo measure in MMN

  3. gamma auditory steady-state response (ASSR) [ Time Frame: 7 and 14 days post baseline ]
    Change from placebo measure in ASSR



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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03860597


Contacts
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Contact: Jo Talledo Benrubi, B.A. 6195433093 atalledo@ucsd.edu
Contact: Neal Swerdlow, M.D., Ph.D. 6195436270 nswerdlow@ucsd.edu

Locations
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United States, California
Clinical Teaching Facility (CTF-B102) at UCSD Medical Center Recruiting
San Diego, California, United States, 92103
Contact: Jo Talledo Benrubi, B.A.    619-543-3093    atalledo@ucsd.edu   
Principal Investigator: Neal R. Swerdlow, M.D., Ph.D.         
Sponsors and Collaborators
University of California, San Diego

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Responsible Party: Neal R. Swerdlow, M.D., Ph.D., Principal Investigator, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03860597     History of Changes
Other Study ID Numbers: R01MH094320 ( U.S. NIH Grant/Contract )
First Posted: March 4, 2019    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Disease
Schizophrenia
Psychotic Disorders
Mood Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Memantine
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents