Serotonin and Motor Plasticity

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.

Study Overview

• Status: Unknown
• Conditions: Healthy Controls
• Intervention / Treatment: Drug: Escitalopram; Drug: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Saxony
    • Leipzig, Saxony, Germany, 04103
      • Recruiting
      • Max Planck Institute for Cognition and Brain Sciences
      • Contact: Eoin Molloy; Phone Number: +49 341 9940-2555; Email: molloy@cbs.mpg.de
      • Contact: Alyson Buchenau; Phone Number: +49-0341-9940-2216; Email: buchenau@cbs.mpg.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Interventional group; Half of the participants (n = 30) will receive 20mg of the SSRI Escitalopram.	Drug: Escitalopram; Experimental group participants (n = 30) will receive 20 mg of Escitalopram for 7 days.
PLACEBO_COMPARATOR: Control group; Half of the participants ( n= 30) will receive the placebo.	Drug: Placebo; Control group participants (n = 30) will receive a placebo for 7 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 week

Collaborators and Investigators

• Sponsor: Max Planck Institute for Human Cognitive and Brain Sciences
• Collaborators: University of Leipzig
• Investigators: Study Chair: Arno Villringer, Max Planck Institute for Human Cognitive and Brain Sciences; Study Director: Julia Sacher, Max Planck Institute for Human Cognitive and Brain Sciences

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2017
• Primary Completion (ANTICIPATED): November 30, 2017
• Study Completion (ANTICIPATED): November 30, 2017

Study Registration Dates

• First Submitted: May 18, 2017
• First Submitted That Met QC Criteria: May 19, 2017
• First Posted (ACTUAL): May 22, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 22, 2017
• Last Update Submitted That Met QC Criteria: May 19, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Neuroplasticity; Motor Learning; SSRI
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Antidepressive Agents, Second-Generation; Citalopram
• Other Study ID Numbers: MaxPlanckHCBS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No