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

NCT04396938 | Completed

• 1 other identifier: R49749/RE003
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Neural function

  fMRI resting state analysis

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

• Neural function

  fMRI task analysis

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

• Neural function

  fMRI checkerboard analysis

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

Secondary Outcomes (6)

• Emotional Processing and Cognitive Function

  Data reporting and analysis to be completed within 6 months following study completion.

• Emotional Processing and Cognitive Function

  Data reporting and analysis to be completed within 6 months following study completion.

• Emotional Processing and Cognitive Function

  Data reporting and analysis to be completed within 6 months following study completion.

• Emotional Processing and Cognitive Function

  Data reporting and analysis to be completed within 6 months following study completion.

• Emotional Processing and Cognitive Function

  Data reporting and analysis to be completed within 6 months following study completion.

Study Arms (2)

Lamotrigine

EXPERIMENTAL

Single dose of Lamotrigine (300mg - capsule). In healthy volunteers.

Drug: Lamotrigine

Placebo

PLACEBO COMPARATOR

Placebo capsule: identical appearance to experimental capsule. In healthy volunteers.

Drug: Placebos

Interventions

Lamotrigine DRUG

Active Drug Capsule

Lamotrigine

Placebos DRUG

Placebo Capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

University of Oxford

Oxford, Oxfordshire, OX3 7JX, United Kingdom

Location

Related Publications (4)

• Calabrese JR, Huffman RF, White RL, Edwards S, Thompson TR, Ascher JA, Monaghan ET, Leadbetter RA. Lamotrigine in the acute treatment of bipolar depression: results of five double-blind, placebo-controlled clinical trials. Bipolar Disord. 2008 Mar;10(2):323-33. doi: 10.1111/j.1399-5618.2007.00500.x.

  PMID: 18271912 BACKGROUND

• Deakin JF, Lees J, McKie S, Hallak JE, Williams SR, Dursun SM. Glutamate and the neural basis of the subjective effects of ketamine: a pharmaco-magnetic resonance imaging study. Arch Gen Psychiatry. 2008 Feb;65(2):154-64. doi: 10.1001/archgenpsychiatry.2007.37.

  PMID: 18250253 BACKGROUND

• Doyle OM, De Simoni S, Schwarz AJ, Brittain C, O'Daly OG, Williams SC, Mehta MA. Quantifying the attenuation of the ketamine pharmacological magnetic resonance imaging response in humans: a validation using antipsychotic and glutamatergic agents. J Pharmacol Exp Ther. 2013 Apr;345(1):151-60. doi: 10.1124/jpet.112.201665. Epub 2013 Jan 31.

  PMID: 23370794 BACKGROUND

• Murphy SE, Norbury R, O'Sullivan U, Cowen PJ, Harmer CJ. Effect of a single dose of citalopram on amygdala response to emotional faces. Br J Psychiatry. 2009 Jun;194(6):535-40. doi: 10.1192/bjp.bp.108.056093.

  PMID: 19478294 BACKGROUND

MeSH Terms

Interventions

Lamotrigine

Intervention Hierarchy (Ancestors)

Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Catherine Harmer, PhD

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: May 21, 2020
• Study Start: May 10, 2017
• Primary Completion: November 29, 2018
• Study Completion: August 30, 2019
• Last Updated: May 21, 2020

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)