Enhancement of Learning Associated Neural Plasticity by Selective Serotonin Reuptake Inhibitors

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Brief Summary

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Background:

Conclusive evidence states that the serotonergic system mediates neuroplasticity from early embryonic development until brain maturation in adulthood. This study aims to demonstrate that selective serotonin reuptake inhibitors (SSRIs) enhance learning-dependent neuroplasticity in vivo, hereby contributing to the investigators understanding of the mechanism of action of therapy with SSRIs.

Objectives:

1. To prove a positive influence of SSRIs on structural remodeling during learning, reflected by enhancements of gray and white matter microstructure, connectivity and functionality in brain regions involved in learning processes.
2. To show that this effect is topologically specific, i.e. that enhancements of plasticity markers are found in different regions depending on their involvement during the performance of specific learning tasks.

Study design:

Randomized, double-blind, placebo-controlled, longitudinal mono-center study. 80 healthy subjects will undergo three MRI scanning sessions: 1. baseline, at study entry, 2. after 3 weeks of facial/emotional (n=40) or Chinese character-meaning learning (n=40) and 3. after 3 weeks learning of new associations under administration of an SSRI or placebo.

Methods:

MRI measurements will be performed on a 3 Tesla PRISMA MAGNETOM MR scanner. Changes in gray matter microstructure will be assessed using high-resolution structural MRI and analyzed with voxel-based morphometry (VBM). Diffusion tensor imaging (DTI) enables non-invasive investigation of neuroplasticity in the human brain based on the reduction in mean diffusivity associated with swelling of astrocytes after increased synaptic activity. Resting-state functional MRI (fMRI) will allow for the measurement of changes in functional coupling between brain regions, and fMRI during tasks will assess differential activity in brain regions during learning.

Relevance and implications:

This study aims to provide evidence that SSRIs facilitate cytoarchitectonical restructuring. In addition to expanding the investigators current knowledge on the trophic effects of SSRIs, the results of this study will also elucidate interactions between the serotonergic system and changes to neuronal networks during learning as well as their behavioral consequences. By probing the neurobiological correlates of the antidepressant and anti-anxiety effects of SSRIs, this study will provide a rationale for targeted interventions that harness the neuroplasticity enhancing properties of SSRIs to facilitate therapeutic processes.

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Detailed Description

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Conditions

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Ssri Neuronal Plasticity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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SSRI treatment

Subjects will receive 21 days of 10mg escitalopram treatment while performing learning paradigms.

Group Type EXPERIMENTAL

Escitalopram

Intervention Type DRUG

Tablet 10mg, 21 days

3xMR scan (fMRI, DTI, strucutral MRI)

Intervention Type OTHER

3 Tesla PRISMA MAGNETOM MR scanner; performed at baseline, after 21 days of performing learning paradigms and after 21 days of drug/placebo treatment and re-learning paradigms

Association learning paradigm

Intervention Type BEHAVIORAL

21 daily internet-based sessions (20min) of learning associations (pairs) of stimuli

Association re-learning paradigm

Intervention Type BEHAVIORAL

21 daily internet-based sessions (20min) of learning new associations (pairs) of stimuli performed during escitalopram/placebo treatment

Placebo treatment

Subjects will receive 21 days of placebo treatment while performing learning paradigms.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Tablet, 21 days

3xMR scan (fMRI, DTI, strucutral MRI)

Intervention Type OTHER

3 Tesla PRISMA MAGNETOM MR scanner; performed at baseline, after 21 days of performing learning paradigms and after 21 days of drug/placebo treatment and re-learning paradigms

Association learning paradigm

Intervention Type BEHAVIORAL

21 daily internet-based sessions (20min) of learning associations (pairs) of stimuli

Association re-learning paradigm

Intervention Type BEHAVIORAL

21 daily internet-based sessions (20min) of learning new associations (pairs) of stimuli performed during escitalopram/placebo treatment

Interventions

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Escitalopram

Tablet 10mg, 21 days

Intervention Type DRUG

Placebo

Tablet, 21 days

Intervention Type DRUG

3xMR scan (fMRI, DTI, strucutral MRI)

3 Tesla PRISMA MAGNETOM MR scanner; performed at baseline, after 21 days of performing learning paradigms and after 21 days of drug/placebo treatment and re-learning paradigms

Intervention Type OTHER

Association learning paradigm

21 daily internet-based sessions (20min) of learning associations (pairs) of stimuli

Intervention Type BEHAVIORAL

Association re-learning paradigm

21 daily internet-based sessions (20min) of learning new associations (pairs) of stimuli performed during escitalopram/placebo treatment

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* General health based on medical history, physical examination and structured clinical interview for DSM-IV (SCID)
* Willingness and competence to sign the informed consent form
* Right-handedness
* Non-smoker, and non-alcohol drinker

Exclusion Criteria

* Any medical, psychiatric or neurological illness
* Current or former substance abuse
* Any implant or stainless steel graft or any other contraindications for MRI
* First degree relatives with a history of psychiatric illness or substance abuse
* Color blindness, any Chinese language skills
* Failure to comply with the study protocol or to follow the instructions of the investigating team
* Lifetime use of SSRIs or related psychotropic agents
* Non-Caucasian

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes