Working MemoryPhase 2FamD_2025NCT06751784
Cross-over Study on the Influence of Fampridine on Working Memory in Mild to Moderate Depression
A Phase 2 study testing Fampridine SR in people with Working Memory and Mild to Moderate Depression, run by University of Basel at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Working Memory, Mild to Moderate Depression
- What is being tested?
- Fampridine SR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteSwitzerland
- Study dates
- 22 May 2025to 31 Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University of Basel, Reserach Cluster Molecular and Cognitive Neurosciences
Basel, Canton of Basel-City, 4055
Dominique de Quervain, Prof., +41 61 207 02 37, dominique.dequervain@unibas.ch
Andreas Papassotiropoulos, Prof, +41 61 207 05 88, andreas.paps@unibas.ch
About this study
Official title: Randomized Placebo-controlled Phase II Cross-over Study on the Influence of Fampridine on Working Memory in Mild to Moderate Depression
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
Read the 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.
- Conditions
- Working Memory, Mild to Moderate Depression
- Being tested
- Fampridine SR, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fampridine SRDrug
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.
PlaceboOther
no active substance
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Experimental: Fampridin 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.
There will be a washout period of at least 6.5 days equaling over 20 half-lives of the active substance fampridine (t½ = 6 h) between experimental and control intervention and up to 28 days depending on the individual scheduling of each subject. Receives: Drug: Fampridine SR |
| Other intervention | Placebo comparator | 15 Identically looking placebo tablets consisting of widely identical additives formulated for oral administration. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
High-load working memory performance.
Letter n-back task which includes a 3-back task assessing working memory. The 3-back task requires participants to respond to a letter repeat with two intervening letters (for example, S-m-b-s-g…). Performance will be quantified with the d' measure controlling for false positives. Parallel versions (different sequences) are used for the four test days.
Measured: Before first intake of study medication and after last intake of study medication of the 7.5-days-treatment periods
Secondary outcomes (9)
Reaction time (for correct 3-back responses).
letter n-back task
Measured: 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.
Letter n-back task.Parallel versions (different sequences) are used for the four test days.
Measured: 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.
The SPAN is a computer-based, adaptively administered test based on item response theory (Rasch model; Rasch, 1980). In the study, test form S2 (backward digit span) is used, which captures both storage capacity and executive functions (Baddeley, 2010). Adaptive administration allows for precise, efficient, and individually tailored assessment while minimizing floor and ceiling effects.
Test scoring is based on the estimation of a continuous person parameter (θ) using weighted maximum likelihood (Warm, 1989). This parameter reflects the individual's latent working memory ability and is additionally converted into a digit span score with decimal precision, allowing for nuanced interpretation (Gignac \& Weiss, 2015).
Measured: 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.
In this test a list of 15 selected words will be presented to the participants with a rate of one word per two seconds and the participant should recall the words immediately in writing (immediate recall). Around 15 minutes later the participants are asked to recall the words again (short delay). Number of correct words recalled in each stage is considered as the participant's immediate and delayed recall score respectively. The four 15-words wordlists (A-D) out of the following test are used: Verbaler Lern-und Merkfähigkeitstest, VLMT
Measured: 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).
Adapted from a subtest of the Regensburger Wortflüssigkeits-Test (RWT). In this task participants should name orally as many words as possible initiating with a special letter in one minute (e.g. Mary, Milk, Mouse, etc. for the letter M) the number of unique meaningful words will be considered as the participant's score.Different letters (B, K, P, M) are used for each test day.
Measured: 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.
In this test, participants will be tasked to rearrange colour balls to match a target arrangement in as few moves as possible. The raw score for planning ability (number of correctly solved trials with the minimum number of ball placements) is consider as the participants score. Parallel version will be used for the four test days.
Measured: 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.
Participants are asked to use the given feedback to work out a rule that determines which stimulus (shapes and lines in different combinations) is correct. After six correct responses, the stimuli and/or rule changes. The shifts in rule are initially intra-dimensional and then later extra-dimensional. The highest reached level is considered as the participant's score. Parallel version will be used for the four test days.
Measured: 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).
The MADRS-s consists of 9 items assessing subjects' mood, inner tension, sleep, appetite, ability to concentrate, initiative, emotional involvement, pessimism and zest for life. Each item is scored between 0 and 6. The total score is calculated by summing the answers of the 9 items, ranging between 0 and 54 (higher scores indicate increased severity).
Measured: 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.
The task follows a classic N-back paradigm with two conditions: 0-back and 2-back.
Emotional faces (happy, sad, neutral; male/female) from the Karolinska Directed Emotional Faces set (Lundqvist et al., 1998) are presented for 1500 ms with a 1350 ms inter-stimulus interval.
Participants indicate whether each stimulus is a "hit" or "non-hit," based on the current stimulus (0-back) or compared to the stimulus two trials prior (2-back).
Measured: Before first intake of study medication and after last intake of study medication of the 7.5-days-treatment periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
- Study start22 May 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Working MemoryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Basel
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Trial Unit, University Hospital Basel, Switzerland
- Responsible party
- Principal investigator, Christiane Gerhards, University of Basel
- Investigators
- Dominique de Quervain, Prof. MD, Study chair, Research Cluster Molecular and Cognitive NeurosciencesAndreas Papassotiropoulos, Prof.MD, Study chair, Research Cluster Molecular and Cognitive NeurosciencesAnnette Bruehl, Prof.MD, Study chair, Zentrum für Affektive -, Stress- und Schlafstörungen & Zentrum für Alterspsychiatrie UPK Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06751784
- Sponsor's protocol ID
- 2024-02355
- Acronym
- FamD_2025
- Status last verified
- Nov 2025
- First submitted
- 20 Dec 2024
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD (de-identified) that underline results in a publication will be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Placebo-controlled Phase II Cross-over Study on the Influence of Fampridine on Working Memory in Mild to Moderate Depression
- ClinicalTrials.gov ID
- NCT06751784
- Acronym / sponsor ID
- FamD_2025 / 2024-02355
- Conditions
- Working Memory, Mild to Moderate Depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- University of BaselUniversity, hospital or other
- Collaborators
- Clinical Trial Unit, University Hospital Basel, Switzerland
- Study start
- 22 May 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 30 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Drug: Fampridine SRExperimental: Fampridin 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. There will be a washout period of at least 6.5 days equaling over 20 half-lives of the active substance fampridine (t½ = 6 h) between experimental and control intervention and up to 28 days depending on the individual scheduling of each subject. |
| Other intervention | Placebo comparator | Other: Placebo15 Identically looking placebo tablets consisting of widely identical additives formulated for oral administration. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (24 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fampridine SRActive 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. | Drug | Intervention |
| Placebono active substance | Other | Other intervention |
Primary outcome
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
Letter n-back task which includes a 3-back task assessing working memory. The 3-back task requires participants to respond to a letter repeat with two intervening letters (for example, S-m-b-s-g…). Performance will be quantified with the d' measure controlling for false positives. Parallel versions (different sequences) are used for the four test days.
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: Yes. All IPD (de-identified) that underline results in a publication will be shared upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dominique de Quervain, Prof. MD study chair
Research Cluster Molecular and Cognitive Neurosciences
Andreas Papassotiropoulos, Prof.MD study chair
Research Cluster Molecular and Cognitive Neurosciences
Annette Bruehl, Prof.MD study chair
Zentrum für Affektive -, Stress- und Schlafstörungen & Zentrum für Alterspsychiatrie UPK Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fampridine SR in people with Working Memory and Mild to Moderate Depression, run by University of Basel at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christiane Gerhards, MD (+41 61 207 0244, christiane.gerhards@unibas.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.