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Completed

NCT Number: NCT04396938

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

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.

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Oxford

Oxford, Oxfordshire, OX3 7JX, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Lamotrigine

Drug

Active Drug Capsule

Placebos

Drug

Placebo Capsule

Primary outcomes

  1. Neural function

    Time frame: Data reporting and analysis to be completed within 1 year following study completion.

    fMRI resting state analysis

  2. Neural function

    Time frame: Data reporting and analysis to be completed within 1 year following study completion.

    fMRI task analysis

  3. Neural function

    Time frame: Data reporting and analysis to be completed within 1 year following study completion.

    fMRI checkerboard analysis

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
May 21, 2020
Registry last updated
May 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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