Healthy ControlsPhase 4NCT03162185
Serotonin and Motor Plasticity
A Phase 4 study testing Escitalopram in people with Healthy Controls, run by Max Planck Institute for Human Cognitive and Brain Sciences at 1 site in Germany.
Trial summary
With this study, the investigators aim to test whether acute administration of selective serotonin reuptake inhibitors (SSRI) improves motor performance in a sequential motor learning task in comparison to placebo in healthy humans. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Controls
- What is being tested?
- Escitalopram
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2017to 30 Nov 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- female
- right-handed
- healthy
- has taken oral contraceptives (ovulation inhibitor) continuously for at least 3 months
- has read and agreed to study parameters
Who cannot join
- tattoos on head or neck
- non-removable metal on or in body
- alcohol abuse
- is currently taking medication
- smokes more than 3 cigarettes per day
- positive drug test
Show all 23Show fewer
- pregnancy
- plays an instrument professionally
- plays videogames more than 2 hours per week
- is a professional athlete
- suffers from migraines
- has taken part in another study, where motor learning skills and/or medication is a factor, in the last 3 months
- heart rhythm disorders (long QT)
- hypertension
- calcium or magnesium deficiency
- neurological disorders
- chronic metabolic disorders
- liver or kidney diseases
- immunodeficiency
- endocrine disorders
- psychiatric disorders
- tumors
- injuries to the head and brain
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Max Planck Institute for Cognition and Brain Sciences
Leipzig, Saxony, 04103
Alyson Buchenau, +49-0341-9940-2216, buchenau@cbs.mpg.de
Eoin Molloy, +49 341 9940-2555, molloy@cbs.mpg.de
About this study
Official title: The Effects of Serotonergic Challenge on Motor Learning and Neuroplasticity
With this study, the investigators aim to test whether acute administration of selective serotonin reuptake inhibitors (SSRI) improves motor performance in a sequential motor learning task in comparison to placebo in healthy humans.
Read the detailed description
Microdialysis findings in animal models provide evidence for a monoaminergic augmentation of motor function. However, this evidence is largely limited to noradrenaline and dopamine, with little evidence to support a similar effect for serotonin. What remains to be tested therefore, is whether acute serotonergic administration induces neural or behavioral changes during motor learning also. Using a sample of 60 female participants (with the possible inclusion of male participants at a later date), the investigators aim to test the effects of a serotonergic challenge on motor learning and plasticity in healthy participants.
- Conditions
- Healthy Controls
- Being tested
- Escitalopram, Placebo
- Keywords
- Neuroplasticity, SSRI, Motor Learning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EscitalopramDrug
Experimental group participants (n = 30) will receive 20 mg of Escitalopram for 7 days.
PlaceboDrug
Control group participants (n = 30) will receive a placebo for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | Half of the participants (n = 30) will receive 20mg of the SSRI Escitalopram. Receives: Drug: Escitalopram |
| Control group | Placebo comparator | Half of the participants ( n= 30) will receive the placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pinch Force Task.
The primary outcome measure will be reaction time and accuracy of motor responses, as measured by the Pinch Force Task. This will be applied to both the experimental (SSRI) and control (Placebo) groups.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start1 Apr 2017
- Primary completion30 Nov 2017 (estimated)
- Study completion30 Nov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ControlsStudies 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Max Planck Institute for Human Cognitive and Brain Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leipzig
- Responsible party
- Sponsor
- Investigators
- Arno Villringer, Study chair, Max Planck Institute for Human Cognitive and Brain SciencesJulia Sacher, Study director, Max Planck Institute for Human Cognitive and Brain Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03162185
- Sponsor's protocol ID
- MaxPlanckHCBS
- Status last verified
- May 2017
- First submitted
- 18 May 2017
- Last updated
- 22 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Serotonergic Challenge on Motor Learning and Neuroplasticity
- ClinicalTrials.gov ID
- NCT03162185
- Acronym / sponsor ID
- MaxPlanckHCBS
- Conditions
- Healthy Controls
- Keywords
- Neuroplasticity, SSRI, Motor Learning
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Max Planck Institute for Human Cognitive and Brain SciencesUniversity, hospital or other
- Collaborators
- University of Leipzig
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 30 Nov 2017 (estimated)
- Study completion
- 30 Nov 2017 (estimated)
- First posted
- 22 May 2017 (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.
With this study, the investigators aim to test whether acute administration of selective serotonin reuptake inhibitors (SSRI) improves motor performance in a sequential motor learning task in comparison to placebo in healthy humans.
Detailed description
Microdialysis findings in animal models provide evidence for a monoaminergic augmentation of motor function. However, this evidence is largely limited to noradrenaline and dopamine, with little evidence to support a similar effect for serotonin. What remains to be tested therefore, is whether acute serotonergic administration induces neural or behavioral changes during motor learning also. Using a sample of 60 female participants (with the possible inclusion of male participants at a later date), the investigators aim to test the effects of a serotonergic challenge on motor learning and plasticity in healthy participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Drug: EscitalopramHalf of the participants (n = 30) will receive 20mg of the SSRI Escitalopram. |
| Control group | Placebo comparator | Drug: PlaceboHalf of the participants ( n= 30) will receive the placebo. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- female
- right-handed
- healthy
- has taken oral contraceptives (ovulation inhibitor) continuously for at least 3 months
- has read and agreed to study parameters
Key exclusion criteria (23 listed)
- tattoos on head or neck
- non-removable metal on or in body
- alcohol abuse
- is currently taking medication
- smokes more than 3 cigarettes per day
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 |
|---|---|---|
| EscitalopramExperimental group participants (n = 30) will receive 20 mg of Escitalopram for 7 days. | Drug | Interventional group |
| PlaceboControl group participants (n = 30) will receive a placebo for 7 days. | Drug | Control group |
Primary outcome
Pinch Force Task.
Time frame: 1 week
The primary outcome measure will be reaction time and accuracy of motor responses, as measured by the Pinch Force Task. This will be applied to both the experimental (SSRI) and control (Placebo) groups.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2017.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Arno Villringer study chair
Max Planck Institute for Human Cognitive and Brain Sciences
Julia Sacher study director
Max Planck Institute for Human Cognitive and Brain Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Escitalopram in people with Healthy Controls, run by Max Planck Institute for Human Cognitive and Brain Sciences at 1 site in Germany.
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 5 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 22 May 2017. 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 Germany. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alyson Buchenau (+49-341-9940-2216, buchenau@cbs.mpg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pinch Force Task. (time frame: 1 week). 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 22 May 2017.