Serotonin and Motor Plasticity

NCT ID: NCT03162185

Last Updated: 2017-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2017-11-30

Brief Summary

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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

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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

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Healthy Controls

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators
Double-blind

Study Groups

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Interventional group

Half of the participants (n = 30) will receive 20mg of the SSRI Escitalopram.

Group Type EXPERIMENTAL

Escitalopram

Intervention Type DRUG

Experimental group participants (n = 30) will receive 20 mg of Escitalopram for 7 days.

Control group

Half of the participants ( n= 30) will receive the placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Control group participants (n = 30) will receive a placebo for 7 days.

Interventions

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Escitalopram

Experimental group participants (n = 30) will receive 20 mg of Escitalopram for 7 days.

Intervention Type DRUG

Placebo

Control group participants (n = 30) will receive a placebo for 7 days.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* female
* right-handed
* healthy
* has taken oral contraceptives (ovulation inhibitor) continuously for at least 3 months
* has read and agreed to study parameters

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Leipzig

OTHER

Sponsor Role collaborator

Max Planck Institute for Human Cognitive and Brain Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arno Villringer

Role: STUDY_CHAIR

Max Planck Institute for Human Cognitive and Brain Sciences

Julia Sacher

Role: STUDY_DIRECTOR

Max Planck Institute for Human Cognitive and Brain Sciences

Locations

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Max Planck Institute for Cognition and Brain Sciences

Leipzig, Saxony, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Alyson Buchenau

Role: CONTACT

+49-341-9940-2216

Eoin Molloy

Role: CONTACT

+49 341 9940-2555

Facility Contacts

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Alyson Buchenau

Role: primary

+49-0341-9940-2216

Eoin Molloy

Role: backup

+49 341 9940-2555

Other Identifiers

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MaxPlanckHCBS

Identifier Type: -

Identifier Source: org_study_id

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