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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Препарат 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.
• Другое Placebo
  no active substance

Первичные конечные точки

• High-load working memory performance. [Срок оценки: Before first intake of study medication and after last intake of study medication of the 7.5-days-treatment periods]

Вторичные конечные точки (9)

• Reaction time (for correct 3-back responses). [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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). [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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). [Срок оценки: 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. [Срок оценки: Before first intake of study medication and after last intake of study medication of the 7.5-days-treatment periods]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Четверное слепое

Основная цель

Фундаментальное исследование

Центры проведения

Швейцария · 1 центр

• University of Basel, Reserach Cluster Molecular and Cognitive Neurosciences — Basel

Идентификаторы

NCT: NCT06751784 · 2024-02355

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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