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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lamotrigine | Experimental | Single dose of Lamotrigine (300mg - capsule). In healthy volunteers. |
|
| Placebo | Placebo Comparator | Placebo capsule: identical appearance to experimental capsule. In healthy volunteers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lamotrigine | Drug | Active Drug Capsule |
| |
| Placebos |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Emotional Processing and Cognitive Function | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine Harmer, PhD | University of Oxford | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Oxford | Oxford | Oxfordshire | OX3 7JX | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18271912 | Background | 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. | |
| 18250253 | Background |
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| ID | Term |
|---|---|
| D000077213 | Lamotrigine |
| ID | Term |
|---|---|
| D014227 | Triazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
Placebo Capsule |
|
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 | 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 | Beck Depression inventory (BDI) questionnaire analysis | Data reporting and analysis to be completed within 6 months following study completion. |
| Emotional Processing and Cognitive Function | 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 | Stait-trait anxiety inventory (STAI) questionnaire analysis | Data reporting and analysis to be completed within 6 months following study completion. |
| 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. |
| 23370794 | 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. |
| 19478294 | 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. |