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Ketamine-Induced Brain Changes and Their Modulation by Lamotrigine

NCT04156035 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2021-03-29

No results posted yet for this study

Summary

This study is firstly designed to investigate acute and delayed effects of a single dose of ketamine on functional brain changes during emotional and cognitive challenges and at rest. Secondly, it aims to investigate whether functional brain changes after ketamine require increased glutamatergic signaling and will accordingly be modulated after pretreatment with lamotrigine.

Conditions

  • Emotions

Interventions

DRUG

Lamotrigine

Orally; 300 mg

DRUG

Ketamine

Intravenously; 0.12 mg/kg during the first minute followed by a continuous infusion of approximately 0.31 mg/kg/h over approx. 40 min

DRUG

Placebo Pretreatment

Lamotrigine Placebo

DRUG

Placebo Infusion

Ketamine Placebo

Sponsors & Collaborators

Principal Investigators

  • Simone Grimm, PhD · Medical School Berlin

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-03-10
Primary Completion
2020-12-10
Completion
2020-12-10

Countries

  • Germany

Study Locations

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Entities

Drugs
Companies

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 NCT04156035 on ClinicalTrials.gov