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

NCT ID: NCT06751784

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-22
• Study Completion Date: 2026-07-31

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

Detailed Description

Randomized placebo-controlled phase II cross-over study on the influence of fampridine on working memory in mild to moderate depression The primary objective of this study is to evaluate if fampridine improves working memory in mild to moderate depression. It will also be assessed whether baseline working memory performance or subjective working memory deficits moderate the drug's effect.

The secondary objectives are to assess the influence of fampridine on different working memory functions, attention, cognitive flexibility, affective working memory and mood.

Intervention:Twice daily oral administration of 10 mg fampridine (Fampyra®) for 7.5 days with a wash-out period of at least 6.5 days Control intervention:Twice daily oral administration of placebo for 7.5 days Study population:Total of 38 participants.

Conditions

Working Memory; Mild to Moderate Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Intervention

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.

Group Type: ACTIVE_COMPARATOR

Fampridine SR

Intervention Type: 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.

Other intervention

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

no active substance

Interventions

Fampridine 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.

Intervention Type: DRUG

Placebo

no active substance

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)
• Other clinically significant concomitant disease states (e.g. hepatic dysfunction, cardiovascular disease, diabetes, asthma)
• Clinically significant laboratory or ECG abnormality that could be a safety issue in the study
• Severe somatic or neurological comorbidities
• Smoking including all nicotine containing smoking systems and devices (>10 cigarettes/units per day). Failure to withstand a test day without craving, due to regular consummation patterns.
• Pregnancy or breast feeding. Intention to become pregnant during the study participation.
• Known or suspected non-compliance
• Inability to follow the procedures of the study, e.g. due to language or psychological problems of the participant
• Participation in another study with an investigational drug within the 30 days preceding and during the present study
• Enrolment of the investigator, his/her family members, employees and other dependent persons

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinical Trial Unit, University Hospital Basel, Switzerland

OTHER

Sponsor Role: collaborator

University of Basel

OTHER

Sponsor Role: lead

Responsible Party

Christiane Gerhards

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dominique de Quervain, Prof. MD

Role: STUDY_CHAIR

Research Cluster Molecular and Cognitive Neurosciences

Andreas Papassotiropoulos, Prof.MD

Role: STUDY_CHAIR

Research Cluster Molecular and Cognitive Neurosciences

Annette Bruehl, Prof.MD

Role: STUDY_CHAIR

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

Locations

University of Basel, Reserach Cluster Molecular and Cognitive Neurosciences

Basel, Canton of Basel-City, Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Christiane Gerhards, MD

Role: CONTACT

christiane.gerhards@unibas.ch

+41 61 207 0244

Facility Contacts

Dominique de Quervain, Prof.

Role: primary

dominique.dequervain@unibas.ch

+41 61 207 02 37

Andreas Papassotiropoulos, Prof

Role: backup

andreas.paps@unibas.ch

+41 61 207 05 88

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan: CTP FamD version 7

View Document

Document Type: Study Protocol and Statistical Analysis Plan: CTP FamD version 6

View Document

Other Identifiers

2024-02355

Identifier Type: -

Identifier Source: org_study_id