Enhancement of Learning Associated Neural Plasticity by Selective Serotonin Reuptake Inhibitors

NCT02753738 | Unknown Phase 4

• 1 other identifier: 21042016
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

Ssri; Neuronal Plasticity

Outcome Measures

Primary Outcomes (2)

• Gray matter volume

  voxel based morphometry (T1 weighted MPRAGE sequence)

  21 days

• Mean diffusivity

  diffusion tensor imaging

  21 days

Secondary Outcomes (1)

• BOLD signal

  21 days

Study Arms (2)

SSRI treatment

EXPERIMENTAL

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

Drug: Escitalopram; Other: 3xMR scan (fMRI, DTI, strucutral MRI); Behavioral: Association learning paradigm; Behavioral: Association re-learning paradigm

Placebo treatment

PLACEBO COMPARATOR

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

Drug: Placebo; Other: 3xMR scan (fMRI, DTI, strucutral MRI); Behavioral: Association learning paradigm; Behavioral: Association re-learning paradigm

Interventions

Escitalopram DRUG

Tablet 10mg, 21 days

SSRI treatment

Placebo DRUG

Tablet, 21 days

Placebo treatment

3xMR scan (fMRI, DTI, strucutral MRI) 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

Placebo treatment; SSRI treatment

Association learning paradigm BEHAVIORAL

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

Placebo treatment; SSRI treatment

Association re-learning paradigm BEHAVIORAL

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

Placebo treatment; SSRI treatment

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Psychiatry and Psychotherapy, Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (2)

• Vanicek T, Reed MB, Seiger R, Godbersen GM, Klobl M, Unterholzner J, Spurny-Dworak B, Gryglewski G, Handschuh P, Schmidt C, Kraus C, Stimpfl T, Rupprecht R, Kasper S, Lanzenberger R. Increased left dorsolateral prefrontal cortex density following escitalopram intake during relearning: a randomized, placebo-controlled trial in healthy humans. Ther Adv Psychopharmacol. 2022 Nov 17;12:20451253221132085. doi: 10.1177/20451253221132085. eCollection 2022.

  PMID: 36420117 DERIVED

• Vanicek T, Reed MB, Unterholzner J, Klobl M, Godbersen GM, Handschuh PA, Spurny-Dworak B, Ritter V, Gryglewski G, Kraus C, Winkler D, Lanzenberger R, Seiger R. Escitalopram administration, relearning, and neuroplastic effects: A diffusion tensor imaging study in healthy individuals. J Affect Disord. 2022 Mar 15;301:426-432. doi: 10.1016/j.jad.2021.12.135. Epub 2022 Jan 10.

  PMID: 35016914 DERIVED

MeSH Terms

Interventions

Escitalopram; Diffusion Tensor Imaging

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diffusion Magnetic Resonance Imaging; Magnetic Resonance Imaging; Tomography; Diagnostic Techniques, Neurological; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof MD

Study Record Dates

• First Submitted: April 21, 2016
• First Posted: April 28, 2016
• Study Start: August 1, 2016
• Primary Completion: August 1, 2019
• Last Updated: April 28, 2016

Record last verified: 2016-04

Locations

AU (1)