Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT06751784

PHASE2

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

Sponsor: University of Basel

View on ClinicalTrials.gov

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

Official title: Randomized Placebo-controlled Phase II Cross-over Study on the Influence of Fampridine on Working Memory in Mild to Moderate Depression

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-05-22

Completion Date

2026-07

Last Updated

2025-12-12

Healthy Volunteers

Conditions

Working Memory Mild to Moderate Depression

Interventions

DRUG

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.

OTHER

Placebo

no active substance

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

Locations (1)

University of Basel, Reserach Cluster Molecular and Cognitive Neurosciences

Basel, Canton of Basel-City, Switzerland