Mechanism of tDCS-induced Learning Enhancement - the Role of Serotonin

NCT ID: NCT02092974

Last Updated: 2021-05-12

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-12-31

Brief Summary

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The aim of this study is to assess whether the application of a selective serotonin reuptake inhibitor (SSRI) enhances and prolongs the learning enhancement achieved by anodal transcranial direct current stimulation (atDCS). For this, young and older healthy subjects will be tested with a well established learning paradigm. Results of this study may help to support the application of atDCS also in patients, e.g. with dementia or mild cognitive impairment.

Detailed Description

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Conditions

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Healthy Young and Older Adults

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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tDCS + SSRI

Group Type EXPERIMENTAL

tDCS

Intervention Type PROCEDURE

Citalopram

Intervention Type DRUG

tDCS + placebo

Group Type PLACEBO_COMPARATOR

tDCS

Intervention Type PROCEDURE

sham-tDCS + SSRI

Group Type SHAM_COMPARATOR

Citalopram

Intervention Type DRUG

sham-DCS + placebo

Group Type PLACEBO_COMPARATOR

sham-tDCS + placebo

Intervention Type OTHER

Interventions

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tDCS

Intervention Type PROCEDURE

Citalopram

Intervention Type DRUG

sham-tDCS + placebo

Intervention Type OTHER

Other Intervention Names

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transcranial direct current stimulation SSRI

Eligibility Criteria

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Inclusion Criteria

* right handedness
* unobtrusive neuropsychological screening
* ability to provide written informed consent
* no pathological findings in head MRI
* age: 18 to 35 years (young adults) or 50-80 years (older adults)
* Highly effective contraception (Pearl Index \< 1) or reliable abstinence from any heterosexual relationships in women of childbearing potential

Exclusion Criteria

* severe internal or psychiatric disease (especially depression or suicidal thoughts)
* epilepsy
* cognitive impairment (\< SD under age adjusted norm in neuropsychological testing)
* concurrent taking of serotonin precursors (tryptophan, 5-HTP) or MAO inhibitors
* concurrent taking of tramadol or triptans
* concurrent taking of pimozide or linezolid
* concurrent taking of other drugs prolonging the QT-interval
* long-QT-syndrome
* hypokalemia or hypomagnesemia
* known intolerance of the study medication
* pregnancy or lactation
* participation in another drug-interventional clinical trial within the last month or during the entire study
* probands that are placed in an institution due to official or judicial order
* non-agreement to save and transmit pseudonymised study data within the clinical trial
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Agnes Flöel

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Agnes Flöel, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

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Charite Universitätsmedizin Berlin

Berlin, , Germany

Site Status

Countries

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Germany

References

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Prehn K, Stengl H, Grittner U, Kosiolek R, Olschlager A, Weidemann A, Floel A. Effects of Anodal Transcranial Direct Current Stimulation and Serotonergic Enhancement on Memory Performance in Young and Older Adults. Neuropsychopharmacology. 2017 Jan;42(2):551-561. doi: 10.1038/npp.2016.170. Epub 2016 Aug 24.

Reference Type RESULT
PMID: 27555381 (View on PubMed)

Other Identifiers

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LESO

Identifier Type: -

Identifier Source: org_study_id

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