NCT03162185

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2017

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 22, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2017

Completed
Last Updated

May 22, 2017

Status Verified

May 1, 2017

Enrollment Period

8 months

First QC Date

May 18, 2017

Last Update Submit

May 19, 2017

Conditions

Keywords

NeuroplasticitySSRIMotor Learning

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Interventional group

EXPERIMENTAL

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

Drug: Escitalopram

Control group

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

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

Interventional group

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

Control group

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Max Planck Institute for Cognition and Brain Sciences

Leipzig, Saxony, 04103, Germany

RECRUITING

MeSH Terms

Interventions

Escitalopram

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Arno Villringer

    Max Planck Institute for Human Cognitive and Brain Sciences

    STUDY CHAIR
  • Julia Sacher

    Max Planck Institute for Human Cognitive and Brain Sciences

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double-blind
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2017

First Posted

May 22, 2017

Study Start

April 1, 2017

Primary Completion

November 30, 2017

Study Completion

November 30, 2017

Last Updated

May 22, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations