Fampridine for working memory in mild to moderate depression
Randomized Placebo-controlled Phase II Cross-over Study on the Influence of Fampridine on Working Memory in Mild to Moderate Depression
This trial will test whether taking fampridine improves working memory in adults with mild to moderate depression.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 38 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | University of Basel Academic / other |
| Locations | 1 site (Basel, Canton of Basel-City) |
| Trial ID | NCT06751784 on ClinicalTrials.gov |
What this trial studies
This is a randomized, placebo-controlled Phase II cross-over trial in which 38 adults with mild to moderate depression will receive fampridine 10 mg twice daily for 7.5 days and placebo for 7.5 days, separated by at least a 6.5-day washout. Working memory performance is the primary outcome, and the study will also measure attention, cognitive flexibility, affective working memory, and mood. Investigators will examine whether baseline working memory performance or subjective memory complaints change the drug's effect. All testing is conducted in person at the University of Basel research site.
Who should consider this trial
Good fit: Adults aged 18–55 with a current mild to moderate major depressive episode (MADRS 7–30), fluent in German, medically stable (normotensive or treated hypertension), BMI 19–34.9, and willing to stop contraindicated medications are ideal candidates.
Not a fit: People with severe depression or significant suicidal ideation, other acute or chronic psychiatric disorders, current psychoactive medication use, recent antidepressant/antipsychotic treatment, cognitive impairment (MoCA <25), or contraindications to 4-aminopyridine are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, fampridine could improve working memory and related daily functioning for people with mild to moderate depression.
How similar studies have performed: Prior work in healthy volunteers (Papassotiropoulos et al., 2024) showed fampridine can boost working memory in lower-performing individuals, but its effect in depressed patients is novel and untested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Basel, Canton of Basel-City
- University of Basel, Reserach Cluster Molecular and Cognitive Neurosciences — Basel, Canton of Basel-City, Switzerland (Recruiting)
Study contacts
- Study coordinator: Christiane Gerhards, MD
- Email: christiane.gerhards@unibas.ch
- Phone: +41 61 207 0244
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.