Fampridine for working memory in mild to moderate depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.