SsriPhase 4NCT02753738
Enhancement of Learning Associated Neural Plasticity by Selective Serotonin Reuptake Inhibitors
A Phase 4 study testing Escitalopram, 3xMR scan (fMRI, DTI, strucutral MRI) and Association learning paradigm in people with Ssri and Neuronal Plasticity, run by Medical University of Vienna at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Ssri, Neuronal Plasticity
- What is being tested?
- Escitalopram, 3xMR scan (fMRI, DTI, strucutral MRI) and Association learning paradigm
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteAustria
- Study dates
- Aug 2016to Aug 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Psychiatry and Psychotherapy, Medical University of Vienna
Vienna, 1090
About this study
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.
Read more
Objectives:
- 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.
- 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.
- Conditions
- Ssri, Neuronal Plasticity
- Being tested
- Escitalopram, Placebo, 3xMR scan (fMRI, DTI, strucutral MRI), Association learning paradigm, Association re-learning paradigm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EscitalopramDrug
Tablet 10mg, 21 days
PlaceboDrug
Tablet, 21 days
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
Association learning paradigmBehavioural
21 daily internet-based sessions (20min) of learning associations (pairs) of stimuli
Association re-learning paradigmBehavioural
21 daily internet-based sessions (20min) of learning new associations (pairs) of stimuli performed during escitalopram/placebo treatment
| Study group | Role | What they receive |
|---|---|---|
| SSRI treatment | Experimental | Subjects will receive 21 days of 10mg escitalopram treatment while performing learning paradigms. Receives: 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. Receives: Drug: Placebo; Other: 3xMR scan (fMRI, DTI, strucutral MRI); Behavioral: Association learning paradigm; Behavioral: Association re-learning paradigm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gray matter volume
voxel based morphometry (T1 weighted MPRAGE sequence)
Measured: 21 days
Mean diffusivity
diffusion tensor imaging
Measured: 21 days
Secondary outcomes (1)
BOLD signal
functional MRI (learning paradigms)
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SsriStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rupert Lanzenberger, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02753738
- Sponsor's protocol ID
- 21042016
- Status last verified
- Apr 2016
- First submitted
- 21 Apr 2016
- Last updated
- 28 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 36420117Vanicek 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.
PubMed 35016914
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancement of Learning Associated Neural Plasticity by Selective Serotonin Reuptake Inhibitors
- ClinicalTrials.gov ID
- NCT02753738
- Acronym / sponsor ID
- 21042016
- Conditions
- Ssri, Neuronal Plasticity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Aug 2019 (estimated)
- First posted
- 28 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SSRI treatment | Experimental | Drug: Escitalopram, Other: 3xMR scan (fMRI, DTI, strucutral MRI), Behavioral: Association learning paradigm, Behavioral: Association re-learning paradigmSubjects will receive 21 days of 10mg escitalopram treatment while performing learning paradigms. |
| Placebo treatment | Placebo comparator | Drug: Placebo, Other: 3xMR scan (fMRI, DTI, strucutral MRI), Behavioral: Association learning paradigm, Behavioral: Association re-learning paradigmSubjects will receive 21 days of placebo treatment while performing learning paradigms. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EscitalopramTablet 10mg, 21 days | Drug | SSRI treatment |
| PlaceboTablet, 21 days | Drug | Placebo treatment |
| 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 | Other | Placebo treatment, SSRI treatment |
| Association learning paradigm21 daily internet-based sessions (20min) of learning associations (pairs) of stimuli | Behavioural | Placebo treatment, SSRI treatment |
| Association re-learning paradigm21 daily internet-based sessions (20min) of learning new associations (pairs) of stimuli performed during escitalopram/placebo treatment | Behavioural | Placebo treatment, SSRI treatment |
Primary outcome
Gray matter volume
Time frame: 21 days
voxel based morphometry (T1 weighted MPRAGE sequence)
Mean diffusivity
Time frame: 21 days
diffusion tensor imaging
1 secondary outcome
BOLD signal
Time frame: 21 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2016.
- Derived from this study: PubMed 36420117Vanicek 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.
- Derived from this study: PubMed 35016914Vanicek 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Escitalopram, 3xMR scan (fMRI, DTI, strucutral MRI) and Association learning paradigm in people with Ssri and Neuronal Plasticity, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gray matter volume (time frame: 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02753738, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2016.