Cross-over Study on the Influence of Fampridine on Working Memory in Mild to Moderate Depression
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fampridine SR, Placebo.
- Who it may be relevant to
- Registry conditions: Working Memory, Mild to Moderate Depression. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Randomized Placebo-controlled Phase II Cross-over Study on the Influence of Fampridine on Working Memory in Mild to Moderate Depression
Overview
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.
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
Primary outcome measures
- High-load working memory performance. [Time frame: Before first intake of study medication and after last intake of study medication of the 7.5-days-treatment periods]
Secondary outcome measures (9)
- Reaction time (for correct 3-back responses). [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: 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). [Time frame: Before first intake of study medication and after last intake of study medication of the 7.5-days-treatment periods]
- Planning and Problem solving, key aspects of executive functioningwill be measured with the "Tower of London" (ToL) test. [Time frame: Before first intake of study medication and after last intake of study medication of the 7.5-days-treatment periods]
- Cognitive Flexibility will be assessed through the "Intra-Extra Dimensional Set Shifting (IED)" task. [Time frame: Before first intake of study medication and after last intake of study medication of the 7.5-days-treatment periods]
- The severity of depressive symptoms will be assessed using MADRS-s (self-rating). [Time frame: Before first intake of study medication and after last intake of study medication of the 7.5-days-treatment periods]
- The affective working memory will be assessed using an emotioanl 2-back. [Time frame: Before first intake of study medication and after last intake of study medication of the 7.5-days-treatment periods]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Quadruple blind
- Primary purpose
- Basic science
Study locations
Switzerland · 1 center
- University of Basel, Reserach Cluster Molecular and Cognitive Neurosciences — Basel
Identifiers
NCT: NCT06751784 · 2024-02355