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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04396938
Enrollment
36
Registered
2020-05-21
Start date
2017-05-10
Completion date
2019-08-30
Last updated
2020-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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.

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.

Interventions

DRUGLamotrigine

Active Drug Capsule

DRUGPlacebos

Placebo Capsule

Sponsors

University of Oxford
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Neural functionData reporting and analysis to be completed within 1 year following study completion.fMRI resting state analysis

Secondary

MeasureTime frameDescription
Emotional Processing and Cognitive FunctionData reporting and analysis to be completed within 6 months following study completion.Analysis of recognition of emotion in faces (an Emotional Test Battery component)

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026