Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Enhancement of Learning Associated Neural Plasticity by Selective Serotonin Reuptake Inhibitors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02753738
Recruitment Status : Unknown
Verified April 2016 by Rupert Lanzenberger, Medical University of Vienna.
Recruitment status was:  Not yet recruiting
First Posted : April 28, 2016
Last Update Posted : April 28, 2016
Sponsor:
Information provided by (Responsible Party):
Rupert Lanzenberger, Medical University of Vienna

Tracking Information
First Submitted Date  ICMJE April 21, 2016
First Posted Date  ICMJE April 28, 2016
Last Update Posted Date April 28, 2016
Study Start Date  ICMJE August 2016
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2016)
  • Gray matter volume [ Time Frame: 21 days ]
    voxel based morphometry (T1 weighted MPRAGE sequence)
  • Mean diffusivity [ Time Frame: 21 days ]
    diffusion tensor imaging
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2016)
BOLD signal [ Time Frame: 21 days ]
functional MRI (learning paradigms)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Enhancement of Learning Associated Neural Plasticity by Selective Serotonin Reuptake Inhibitors
Official Title  ICMJE Enhancement of Learning Associated Neural Plasticity by Selective Serotonin Reuptake Inhibitors
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE
  • Ssri
  • Neuronal Plasticity
Intervention  ICMJE
  • Drug: Escitalopram
    Tablet 10mg, 21 days
  • Drug: Placebo
    Tablet, 21 days
  • Other: 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
  • Behavioral: Association learning paradigm
    21 daily internet-based sessions (20min) of learning associations (pairs) of stimuli
  • Behavioral: Association re-learning paradigm
    21 daily internet-based sessions (20min) of learning new associations (pairs) of stimuli performed during escitalopram/placebo treatment
Study Arms  ICMJE
  • Experimental: SSRI treatment
    Subjects will receive 21 days of 10mg escitalopram treatment while performing learning paradigms.
    Interventions:
    • Drug: Escitalopram
    • Other: 3xMR scan (fMRI, DTI, strucutral MRI)
    • Behavioral: Association learning paradigm
    • Behavioral: Association re-learning paradigm
  • Placebo Comparator: Placebo treatment
    Subjects will receive 21 days of placebo treatment while performing learning paradigms.
    Interventions:
    • Drug: Placebo
    • Other: 3xMR scan (fMRI, DTI, strucutral MRI)
    • Behavioral: Association learning paradigm
    • Behavioral: Association re-learning paradigm
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 25, 2016)
80
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02753738
Other Study ID Numbers  ICMJE 21042016
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rupert Lanzenberger, Medical University of Vienna
Study Sponsor  ICMJE Medical University of Vienna
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Medical University of Vienna
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP