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Memantine Effects on Sensorimotor Gating and Neurocognition in Schizophrenia

NCT ID: NCT03860597

Last Updated: 2022-12-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-01

Study Completion Date

2021-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Schizophrenia Schizo Affective Disorder Schizoaffective Disorder Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Memantine

Group Type ACTIVE_COMPARATOR

Memantine

Intervention Type DRUG

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

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Neal R. Swerdlow, M.D., Ph.D.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Clinical Teaching Facility (CTF-B102) at UCSD Medical Center

San Diego, California, United States

Site Status

Countries

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United States

References

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Molina JL, Voytek B, Thomas ML, Joshi YB, Bhakta SG, Talledo JA, Swerdlow NR, Light GA. Memantine Effects on Electroencephalographic Measures of Putative Excitatory/Inhibitory Balance in Schizophrenia. Biol Psychiatry Cogn Neurosci Neuroimaging. 2020 Jun;5(6):562-568. doi: 10.1016/j.bpsc.2020.02.004. Epub 2020 Feb 22.

Reference Type DERIVED
PMID: 32340927 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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R01MH094320

Identifier Type: NIH

Identifier Source: org_study_id

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