CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 46 enrolled
Drug / intervention
Lamotrigine 300 MG +2 moredrug
Likely dose
Lamotrigine 300 MGfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03831854
NCT03831854Phase 3Completed
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The Role of Lamotrigine in Reducing Psychologic Side-Effect of Perioperative Ketamine Use

The Cleveland Clinic·interventional·Posted Feb 6, 2019·Updated Jun 9, 2021

In Brief

A Phase 3 clinical trial evaluating Lamotrigine 300 MG, Placebo, and 1 other intervention for Reducing Psychological Side Effects of Ketamine. Completed, enrolled 46 participants across 1 site.

Detailed Summary

Patient will receive lamotrigine vs. placebo with small sips of water. Lamotrigine reaches peak level 1-4 hours after oral administration.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsReducing Psychological Side Effects of Ketamine
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedFeb 6, 2019
Enrollment StartJan 24, 2019
Primary CompletionDec 31, 2020
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 7.4 years ago

Interventions

Lamotrigine 300 MGdrug

300 mg of oral Lamotrigine. One of the key studies in this area was reported at the Society of Neuroscience meeting in 1997 and later published in the Archives of General Psychiatry. This study reported that, in healthy subjects 300 mg oral lamotrigine significantly decreased ketamine-induced perceptual abnormalities as assessed by the Clinician-Administered Dissociative States Scale (P\<.001).31 Furthermore lamotrigine increased the immediate mood-elevating effects of ketamine (P\<.05).

Placebodrug

300 mg of oral Placebo

Ketaminedrug

1mg/kg bolus at induction followed by 5 microgram/kg/min infusion till the end of the surgery