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New treatment option for Working Memory
Official title Cross-over Study on the Influence of Fampridine on Working Memory in Mild to Moderate Depression
ClinicalTrials.gov ID: NCT06751784
What this study is testing
What is Fampridine SR?
Fampridine SR is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for working memory.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55
You may be able to join if
- 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 people will be included.
- BMI: 19 - 34,9 kg/m2
- Age: 18 - 55 years
You likely can't join if
- 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)
See the full eligibility 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 people will be included.
- BMI: 19 - 34,9 kg/m2
- Age: 18 - 55 years
- Fluent in German
- IC as documented by signature
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Basel, Canton of Basel-City, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basel, Canton of Basel-City, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.