Cross-over Study on the Influence of Fampridine on Working Memory in Mild to Moderate Depression
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-55
SponsorUniversity of Basel
About this trial
Cognitive deficits, including working memory deficits, are often present in depression and there are currently no effective pharmacological treatments targeting working memory deficits. Papassotiropoulos et al. (2024) has recently demonstrated that fampridine, a potassium channel blocker, can enhance working memory in healthy individuals with lower baseline performance, suggesting it may hold potential for addressing cognitive deficits in clinical populations. The primary aim of this study is to evaluate whether fampridine improves working memory performance in mild to moderate depression
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female
Major depressive episode confirmed by the Mini-DIPS. Currently mild to moderate (MADRS: 7-30).
Normotensive (BP: 90/60mmHg - 140/90mmHg). Sufficiently treated hypertensive subjects will be included.
BMI: 19 - 34,9 kg/m2
Disqualifiers
Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to 4-aminopyridine
Use of potassium channel blockers within the last 3 months
Treatment with OCT 2 inhibitors and -substrates (e.g. cimetidine, propranolol)
Treatment with antidepressants or antipsychotics within the last 3 months and throughout the study period
Trial design
Design model
Crossover
Treatments tested in this trial
Fampridine SR
DrugActive study medication consists of 15 tablets of fampridine SR 10 mg formulated for oral administration taken in the morning and evening 12 h apart without food. Tablets must be administered whole.
Placebo
Other interventionno active substance
Treatment groups
38 Participants
are divided into 2 treatment groupsGroup A: InterventionActive comparator 1 intervention
Group B: Other interventionPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
High-load working memory performance.
Letter n-back task which includes a 3-back task assessing working memory. The 3-back task requires participants to respond to a letter repeat with two intervening letters (for example, S-m-b-s-g…). Performance will be quantified with the d' measure controlling for false positives. Parallel versions (different sequences) are used for the four test days.
Time frame
Before first intake of study medication and after last intake of study medication of the 7.5-days-treatment periodsSecondary outcomes
1
Reaction time (for correct 3-back responses).
letter n-back task
Time frame
Before first intake of study medication and after last intake of study medication of the 7.5-days-treatment periods2
Performance in a 0-back task (d') as a measure of attention.
Letter n-back task.Parallel versions (different sequences) are used for the four test days.
Time frame
Before first intake of study medication and after last intake of study medication of the 7.5-days-treatment periods3
Adaptive verbal working memory capacity test (SPAN) backward.
The SPAN is a computer-based, adaptively administered test based on item response theory (Rasch model; Rasch, 1980). In the study, test form S2 (backward digit span) is used, which captures both storage capacity and executive functions (Baddeley, 2010). Adaptive administration allows for precise, efficient, and individually tailored assessment while minimizing floor and ceiling effects. Test scoring is based on the estimation of a continuous person parameter (θ) using weighted maximum likelihood (Warm, 1989). This parameter reflects the individual's latent working memory ability and is additionally converted into a digit span score with decimal precision, allowing for nuanced interpretation (Gignac \& Weiss, 2015).
Time frame
Before first intake of study medication and after last intake of study medication of the 7.5-days-treatment periods4
Verbal episodic memory performance measured by immediate and delayed word-list recall task.
In this test a list of 15 selected words will be presented to the participants with a rate of one word per two seconds and the participant should recall the words immediately in writing (immediate recall). Around 15 minutes later the participants are asked to recall the words again (short delay). Number of correct words recalled in each stage is considered as the participant's immediate and delayed recall score respectively. The four 15-words wordlists (A-D) out of the following test are used: Verbaler Lern-und Merkfähigkeitstest, VLMT
Time frame
Before first intake of study medication and after last intake of study medication of the 7.5-days-treatment periodsSponsors and contacts
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University of Basel
Lead sponsor
Clinical Trial Unit, University Hospital Basel, Switzerland
Collaborator
Source ClinicalTrials.gov