Influence of Fampridine on Working Memory in Individuals with Mild Depression
Descrizione riassuntiva dello studio
Location of study: Department of Cognitive Neurosciences, University of Basel Number of participants: 38 Planned duration of study: 15 months Procedure for study participation The study takes place at 5 appointments within 4-8 weeks at the Department of Cognitive Neurosciences at the University of Basel. The appointments include a screening appointment and four testing days. The screening (including ECG examination and blood draw) serves to clarify eligibility for study participation. This is followed by 2 dosing phases of 7.5 days each, during which participants either take the active substance Fampridine as a tablet (10 mg) twice daily or - in the other phase - tablets without active substance (placebo). A testing day takes place at the beginning and end of the dosing phases, during which participants solve memory tasks and fill out questionnaires. The testing days last 3 to a maximum of 4.5 hours. Between the two dosing phases, there are 6 to a maximum of 26 days. Participation requirements You suffer from a depressed mood, for which you do not take any medications (including herbal ones) and are not under medical or psychological treatment. You are 18-30 years old, speak German very well, and do not suffer from physical or psychological comorbidities. Benefit It is possible that you may notice a beneficial change in your working memory during one of the treatment phases. Furthermore, the study has no direct benefit for you. The insights gained from this study are intended to help improve the treatment of working memory disorders, a common symptom in individuals with depression.
(BASEC)
Intervento studiato
The active study medication consists of 15 tablets (7.5 days) of Fampridine 10 mg.
The medication is used to treat gait disorders in people with multiple sclerosis. We therefore want to investigate a different use than the approved one.
(BASEC)
Malattie studiate
The study investigates whether the active substance Fampridine has a positive effect on working memory in individuals with mild depression.
(BASEC)
All German-speaking individuals (native German speakers or very good German speakers) suffering from mild depression and aged between 18 and 30 years can participate. (BASEC)
Criteri di esclusione
Individuals who • take medications (including herbal ones) due to their depressive symptoms or are under medical or psychological care; • have impaired kidney function; • have a history of epileptic seizures or suffer from severe sleep disturbances or have a family history of epileptic seizures; • have psychiatric disorders such as schizophrenia; • have alcohol or drug problems; • are currently participating in another medical (minimum interval of 30 days) and/or psychological study; • have certain conditions or take certain medications that would pose a safety risk (to be verified by the study physician); • have thoughts of self-harm. Women may not participate if they are pregnant, breastfeeding, or intend to become pregnant in the coming weeks. (BASEC)
Luogo dello studio
Basilea
(BASEC)
Sponsor
Universität Basel
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Christiane Gerhards
+41 61 207 02 44
christiane.gerhards@clutterunibas.chUniversität Basel Medizinische Fakultät Abteilung für Kognitive Neurowissenschaften Birmannsgasse 8 4055 Basel
(BASEC)
Informazioni generali
Research Cluster Molecular and Cognitive Neurosciences,Research Cluster Molecular and Cognitive Neurosciences,Zentrum f?r Affektive -, Stress- und Schlafst?rungen & Zentrum f?r Alterspsychiatrie UPK Basel,
+41 61 207 0244;+41 61 207 02 37
christiane.gerhards@clutterunibas.ch(ICTRP)
Informazioni generali
Research Cluster Molecular and Cognitive NeurosciencesResearch Cluster Molecular and Cognitive NeurosciencesZentrum fr Affektive -, Stress- und Schlafstrungen & Zentrum fr Alterspsychiatrie UPK Basel
+41 61 207 0244+41 61 207 02 37
christiane.gerhards@clutterunibas.ch(ICTRP)
Informazioni scientifiche
Research Cluster Molecular and Cognitive Neurosciences,Research Cluster Molecular and Cognitive Neurosciences,Zentrum f?r Affektive -, Stress- und Schlafst?rungen & Zentrum f?r Alterspsychiatrie UPK Basel,
+41 61 207 0244;+41 61 207 02 37
christiane.gerhards@clutterunibas.ch(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica svizzera nord-ovest/centrale EKNZ
(BASEC)
Data di approvazione del comitato etico
15.01.2025
(BASEC)
ID di studio ICTRP
NCT06751784 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
Randomized placebo-controlled phase II cross-over study on the influence of fampridine on working memory in mild depression (BASEC)
Titolo accademico
Randomized Placebo-controlled Phase II Cross-over Study on the Influence of Fampridine on Working Memory in Mild Depression (ICTRP)
Titolo pubblico
Cross-over Study on the Influence of Fampridine on Working Memory in Mild Depression (ICTRP)
Malattie studiate
Working MemoryMild Depression (ICTRP)
Intervento studiato
Drug: Fampridine SROther: Placebo (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Criteri di inclusione/esclusione
Inclusion Criteria:
- Male or female
- Major depressive episode confirmed by the Mini-DIPS. Currently mild (MADRS: 7-19).
- Normotensive (BP: 90/60mmHg - 140/90mmHg). Sufficiently treated hypertensive
subjects will be included.
- BMI: 19 - 34,9 kg/m2
- Age: 18 - 30 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)
- MADRS item 10 > 0 (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 (>5 cigarettes per day)
- 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
- Prior participation (less than two years ago) in a study investigating working
memory (notably the n-back task)
- Enrolment of the investigator, his/her family members, employees and other dependent
persons (ICTRP)
non disponibile
Endpoint primari e secondari
High-load working memory performance (ICTRP)
Reaction time (for correct 3-back responses).;Performance in a 0-back task (d') as a measure of attention.;Working memory assessed by the digit span task (backward and forward), a subtest of the WIE;Verbal episodic memory performance measured by immediate and delayed word-list recall task;Lexical ability measured by phonemic fluency test (S-words);Planning and Problem solving, key aspects of executive functioningwill be measured with the "Tower of London" (ToL) test;Cognitive Flexibility will be assessed through the "Intra-Extra Dimensional Set Shifting (IED)" task;The severity of depressive symptoms will be assessed using MADRS (self assessment).;The affective working memory will be assessed using an emotioanl 2-back (ICTRP)
Data di registrazione
20.12.2024 (ICTRP)
Inclusione del primo partecipante
non disponibile
Sponsor secondari
Clinical Trial Unit, University Hospital Basel, Switzerland (ICTRP)
Contatti aggiuntivi
Dominique de Quervain, Prof. MD;Andreas Papassotiropoulos, Prof.MD;Annette Bruehl, Prof.MD;Christiane Gerhards, MD;Dominique de Quervain, Prof., christiane.gerhards@unibas.ch; dominique.dequervain@unibas.ch, +41 61 207 0244;+41 61 207 02 37, Research Cluster Molecular and Cognitive Neurosciences,Research Cluster Molecular and Cognitive Neurosciences,Zentrum f?r Affektive -, Stress- und Schlafst?rungen & Zentrum f?r Alterspsychiatrie UPK Basel, (ICTRP)
ID secondari
2024-02355 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT06751784 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile