Mechanism of tDCS-induced Learning Enhancement - the Role of Serotonin (LESO)

Charité University Medicine Berlin

Status and phase: Completed; Phase 1

Conditions: Healthy Young and Older Adults

Treatments: Other: sham-tDCS + placebo; Drug: Citalopram; Procedure: tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT02092974

LESO

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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
• claustrophobia or metallic implants, tattoos (MRI exclusion criteria)
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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40 participants in 4 patient groups, including a placebo group

tDCS + SSRI

Experimental group

Treatment:

Procedure: tDCS

Drug: Citalopram

tDCS + placebo

Placebo Comparator group

Treatment:

Procedure: tDCS

sham-tDCS + SSRI

Sham Comparator group

Treatment:

Drug: Citalopram

sham-DCS + placebo

Placebo Comparator group

Treatment:

Other: sham-tDCS + placebo