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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03162185
Other study ID # MaxPlanckHCBS
Secondary ID
Status Recruiting
Phase Phase 4
First received May 18, 2017
Last updated May 19, 2017
Start date April 1, 2017
Est. completion date November 30, 2017

Study information

Verified date May 2017
Source Max Planck Institute for Human Cognitive and Brain Sciences
Contact Alyson Buchenau
Phone +49-341-9940-2216
Email buchenau@cbs.mpg.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date November 30, 2017
Est. primary completion date November 30, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Escitalopram
Experimental group participants (n = 30) will receive 20 mg of Escitalopram for 7 days.
Placebo
Control group participants (n = 30) will receive a placebo for 7 days.

Locations

Country Name City State
Germany Max Planck Institute for Cognition and Brain Sciences Leipzig Saxony

Sponsors (2)

Lead Sponsor Collaborator
Max Planck Institute for Human Cognitive and Brain Sciences University of Leipzig

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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