Cross-over Study on the Influence of Fampridine on Working Memory in Mild to Moderate Depression

NCT06751784 | Recruiting Phase 2

• 1 other identifier: 2024-02355
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Working Memory; Mild to Moderate Depression

Outcome Measures

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.

  Before first intake of study medication and after last intake of study medication of the 7.5-days-treatment periods

Secondary Outcomes (9)

• Reaction time (for correct 3-back responses).

  Before first intake of study medication and after last intake of study medication of the 7.5-days-treatment periods

• Performance in a 0-back task (d') as a measure of attention.

  Before first intake of study medication and after last intake of study medication of the 7.5-days-treatment periods

• Adaptive verbal working memory capacity test (SPAN) backward.

  Before first intake of study medication and after last intake of study medication of the 7.5-days-treatment periods

• Verbal episodic memory performance measured by immediate and delayed word-list recall task.

  Before first intake of study medication and after last intake of study medication of the 7.5-days-treatment periods

• Lexical ability measured using a phonemic verbal fluency task (S-words).

  Before first intake of study medication and after last intake of study medication of the 7.5-days-treatment periods

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Experimental: Fampridin SR Active 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. There will be a washout period of at least 6.5 days equaling over 20 half-lives of the active substance fampridine (t½ = 6 h) between experimental and control intervention and up to 28 days depending on the individual scheduling of each subject.

Drug: Fampridine SR

Other intervention

PLACEBO COMPARATOR

15 Identically looking placebo tablets consisting of widely identical additives formulated for oral administration.

Other: Placebo

Interventions

Fampridine SR DRUG

Active 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.

Intervention

Placebo OTHER

no active substance

Other intervention

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Age: 18 - 55 years
• Fluent in German
• IC as documented by signature

You may not qualify if:

• 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
• Current intake of psychoactive drugs (e.g. benzodiazepines, antidepressants, neuroleptics).
• Other acute or chronic psychiatric disorder (e.g. psychosis, somatoform disorder, alcohol or drug abuse disorder)
• Cognitive impairment (MoCA score \< 25)
• MADRS item 10 \> 1 (suicidal tendency)
• Risk of lowered seizure threshold (due to e.g. sleep deprivation, withdrawal of alcohol after alcohol abuse, hyponatraemia)
• History of seizures
• Acute cerebrovascular condition
• Acute renal failure or severe renal insufficiency (creatinine clearance \< 30 ml/min per 1.73 m2)
• Bradycardia \< 50/min during clinical examination.
• History of malignant cancers
• Walking problems (e.g. due to dizziness)

Sponsors & Collaborators

• University of Basel: lead
• Clinical Trial Unit, University Hospital Basel, Switzerland: collaborator

Study Sites (1)

University of Basel, Reserach Cluster Molecular and Cognitive Neurosciences

Basel, Canton of Basel-City, 4055, Switzerland

RECRUITING

MeSH Terms

Interventions

4-Aminopyridine

Intervention Hierarchy (Ancestors)

Aminopyridines; Amines; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Dominique de Quervain, Prof. MD

  Research Cluster Molecular and Cognitive Neurosciences

  STUDY CHAIR

• Andreas Papassotiropoulos, Prof.MD

  Research Cluster Molecular and Cognitive Neurosciences

  STUDY CHAIR

• Annette Bruehl, Prof.MD

  Zentrum für Affektive -, Stress- und Schlafstörungen & Zentrum für Alterspsychiatrie UPK Basel

  STUDY CHAIR

Central Study Contacts

Christiane Gerhards, MD

CONTACT

+41 61 207 0244; christiane.gerhards@unibas.ch

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: December 30, 2024
• Study Start: May 22, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: PD will be available after publication, study protocol (including statistical analysis plan) will be made available before start of the study.
• Access Criteria: All IPD (de-identified) that underline results in a publication will be shared upon reasonable request for scientific purposes. A reasonable request consists of a short description of the scientific purpose. Request will be reviewed by the team of the principal investigator.

Locations

CH (1)