A clinical trial investigating the effect of the anti-depressant fluoxetine on learning and memory in people with epilepsy.

Phase 1

• Conditions: Mesial Temporal Lobe Epilepsy; MedDRA version: 18.0 Level: PT Classification code 10043209 Term: Temporal lobe epilepsy System Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2014-005088-34-GB
• Lead Sponsor: Cardiff University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-18
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

The inclusion criteria for this trial are;

•Adult patients between the ages of 18-65yrs
Adult persons over the age of 65 will not be included as neurogenesis (the postulated biological target) diminishes significantly after this age and this subgroup therefore may not benefit. If benefit is shown under 65 then a subsequent study to assess benefit in this age group may be carried out.
•diagnosis of mesial temporal lobe epilepsy
•unilateral hippocampal sclerosis (confirmed by MRI)

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Exclusion Criteria for this trial are;

•bilateral hippocampal sclerosis on MRI
•presence of significant active depression and/ or anxiety as determined by
HADS scoring (11 or above on either subscale)
•Persons lacking capacity or an IQ score of 80 or below as assessed by the
WASI
•presence of poorly controlled seizures in patients undergoing active AED
changes
•any participant not suitable for MRI
•pregnancy
•Wishing to breast feed during the trial
•participation in another clinical trial of an investigational medicinal
product (IMP)
•previous adverse reaction to fluoxetine
•contraindicated concomitant medication – such as Monoamine Oxidase Inhibitors
•hepatic impairment that would require any dose adjustment for fluoxetine
(elevated liver Enzymes (- 2.5 or more times the upper limit of the normal
range).
•congenital long QT syndrome, a family history of QT prolongation or other
clinical conditions that predispose to arrhythmias (e.g., hypokalemia,
hypomagnesemia, bradycardia, acute myocardial infarction or uncompensated
heart failure). An ECG will be performed in patients with a stable cardiac
history. Most patients in our database have already been screeened for
prolonged Q-T syndrome as part of their epilepsy evaluation.
•Patients on Tamoxifen as concomitant Fluoxetine may lead to reduced
concentrations of its active metabolite endoxifen.
•Participants taking St John’s Wort should agree to discontinue it before
taking the IMP. If not, they will be excluded, as St John’s Wort potentiates
the serotonergic effects of Fluoxetine.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified