The Effect of a Single Dose of Lamotrigine on Brain Function in Healthy Volunteers

May 15, 2020 updated by: University of Oxford
This study will test whether a single dose of Lamotrigine (300mg) exerts significant effects on emotional processing, cognitive ability and neural activity in healthy volunteers compared to placebo.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Glutamate has been implicated in the aetiology of mood disorders and there is current interest in developing novel agents targeting this system. However, the role of glutamate in human emotional function is relatively unknown. Lamotrigine's pharmacological profile involves a blockade of voltage-gated sodium channels, leading to an inhibition in the release of glutamate and resulting in a general inhibitory effect on cortical neuronal function.

The current study plans to investigate the effects of modifying glutamate on emotional processing, cognitive function and neural activity. For this, 36 healthy volunteers will be recruited to the study and randomised to receive a single dose of lamotrigine (300 mg) or placebo. Two hours after drug administration, the effects of emotional processing via the use of cognitive tasks will be assessed using fMRI. This will be followed by an emotional test battery that will measure aspects of cognitive function as well.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 7JX
        • University of Oxford

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female
  • Aged 18-40 years
  • Willing and able to give informed consent for participation in the study
  • Sufficiently fluent English to understand and complete the task

Exclusion Criteria:

  • Current usage of psychoactive medication
  • Current usage of the contraceptive pill
  • Any past or current Axis 1 DSM-IV psychiatric disorder
  • Significant medical condition
  • Current pregnancy or breastfeeding
  • Current or past history of drug or alcohol dependency
  • Participation in a psychological or medical study involving the use of medication within the last 3 months
  • Previous participation in a study using the same, or similar, emotional processing tasks
  • Smoker > 5 cigarettes per day
  • Typically drinks > 6 caffeinated drinks per day
  • Takes folic acid supplements
  • History of recurrent allergies and rashes
  • Contraindication to MRI (e.g. claustrophobia and metallic implants)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Lamotrigine
Single dose of Lamotrigine (300mg - capsule). In healthy volunteers.
Drug: Lamotrigine
Active Drug Capsule
PLACEBO_COMPARATOR: Placebo
Placebo capsule: identical appearance to experimental capsule. In healthy volunteers.
Drug: Placebos
Placebo Capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neural function
Time Frame: Data reporting and analysis to be completed within 1 year following study completion.
fMRI resting state analysis
Data reporting and analysis to be completed within 1 year following study completion.
Neural function
Time Frame: Data reporting and analysis to be completed within 1 year following study completion.
fMRI task analysis
Data reporting and analysis to be completed within 1 year following study completion.
Neural function
Time Frame: Data reporting and analysis to be completed within 1 year following study completion.
fMRI checkerboard analysis
Data reporting and analysis to be completed within 1 year following study completion.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emotional Processing and Cognitive Function
Time Frame: Data reporting and analysis to be completed within 6 months following study completion.
Analysis of recognition of emotion in faces (an Emotional Test Battery component)
Data reporting and analysis to be completed within 6 months following study completion.
Emotional Processing and Cognitive Function
Time Frame: Data reporting and analysis to be completed within 6 months following study completion.
Speed of negative self-descriptor processing (an Emotional Test Battery component)
Data reporting and analysis to be completed within 6 months following study completion.
Emotional Processing and Cognitive Function
Time Frame: Data reporting and analysis to be completed within 6 months following study completion.
Emotional memory analysis (an Emotional Test Battery component)
Data reporting and analysis to be completed within 6 months following study completion.
Emotional Processing and Cognitive Function
Time Frame: Data reporting and analysis to be completed within 6 months following study completion.
Beck Depression inventory (BDI) questionnaire analysis
Data reporting and analysis to be completed within 6 months following study completion.
Emotional Processing and Cognitive Function
Time Frame: Data reporting and analysis to be completed within 6 months following study completion.
Positive and negative affect schedule (PANAS) questionnaire analysis
Data reporting and analysis to be completed within 6 months following study completion.
Emotional Processing and Cognitive Function
Time Frame: Data reporting and analysis to be completed within 6 months following study completion.
Stait-trait anxiety inventory (STAI) questionnaire analysis
Data reporting and analysis to be completed within 6 months following study completion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 10, 2017

Primary Completion (ACTUAL)

November 29, 2018

Study Completion (ACTUAL)

August 30, 2019

Study Registration Dates

First Submitted

September 18, 2019

First Submitted That Met QC Criteria

May 15, 2020

First Posted (ACTUAL)

May 21, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 21, 2020

Last Update Submitted That Met QC Criteria

May 15, 2020

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R49749/RE003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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