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Cognitive Changes With Gabapentin Treatment

NCT04106011 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 3

Last updated 2021-03-01

No results posted yet for this study

Summary

This is a single-cohort, prospective, observational study evaluating the effects of gabapentin on cognition. The goal of the study is to determine whether there is a measurable change in cognitive function from baseline in patients who are prescribed gabapentin for the treatment of neuropathic pain.

Conditions

  • Neuralgia Peripheral
  • Pain

Interventions

DRUG

Gabapentin

Titration of gabapentin will be standardized as 300mg QHS and increased by 300mg every 3 days until taking 1200mg TID or maximum tolerable dose. Subjects will undergo cognitive evaluation prior to initiation of the medication, at 1 week (when titrated to approximately 900mg/day), 3 weeks (when titrated to approximately 2100mg/day), and at 6 weeks (when titrated to 3600mg/day or maximum tolerable dose).

DIAGNOSTIC_TEST

BTACT

Cognition measure: Brief Test of Adult Cognition by Telephone

DIAGNOSTIC_TEST

BPI

Pain severity and interference at baseline using the Brief Pain Inventory

DIAGNOSTIC_TEST

HADS

Assessment of depression and anxiety with the Hospital Anxiety and Depression Scale

DIAGNOSTIC_TEST

SLP9

Assessment of Sleep

DIAGNOSTIC_TEST

NPSI

Assessment of neuropathic components

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Jessica Justmann, MD · Washington University School of Medicine

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-10
Primary Completion
2021-02-18
Completion
2021-02-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04106011 on ClinicalTrials.gov