Condition category
Mental and Behavioural Disorders
Date applied
05/12/2019
Date assigned
10/03/2020
Last edited
10/03/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results

Plain English Summary

Background and study aims
Selective serotonin reuptake inhibitors (SSRIs) are considered first-line treatment in depression. However, the exact mechanism of this drug is still not fully understood today. The aim of this study is to investigate the effect of a single oral dose of SSRIs on brain and behavior and compare it to placebo (dummy drug) in healthy volunteers.

Who can participate?
Female and male healthy volunteers between 20 and 30 years of age

What does the study involve?
All participants receive a single oral dose of the SSRI escitalopram and placebo. One group receives escitalopram first and then undergoes a magnetic resonance imaging (MRI) scan 3-4 hours later. After a wash-out period of 8 weeks, this group of participants receives a placebo pill and then again undergoes MRI. A second group starts with the placebo pill and then, after 8 weeks, receives escitalopram. Neither the participants nor the experimenter will know if the participants receive the escitalopram or the placebo pill. Only after the study has finished will the experimenter learn the treatment orders. Before each MRI scan session, participants fill out questionnaires assessing depression and mood.

What are the possible benefits and risks of participating?
Participants receive financial compensation for taking part in the study. A single oral dose of SSRI rarely has minimal temporary side effects, such as nausea, changes in sleep, less sexual arousal, restlessnees, or headaches. MRI scanning does not have harmful effects, only rarely may participants experience circulatory problems.

Where is the study run from?
Max Planck Institute for Human Cognitive and Brain Sciences (Germany)

When is the study starting and how long is it expected to run for?
October 2011 to April 2013

Who is funding the study?
Max Planck Institute for Human Cognitive and Brain Sciences (Germany)

Who is the main contact?
Dr Julia Sacher
sacher@cbs.mpg.de

Trial website

Contact information

Type

Scientific

Primary contact

Dr Julia Sacher

ORCID ID

Contact details

Max Planck Institute for Human Cognitive and Brain Sciences
Stephanstrasse 1A
Leipzig
04103
Germany
+49 (0)341 9940-2409
sacher@cbs.mpg.de

Type

Public

Additional contact

Ms Carolin Lewis

ORCID ID

Contact details

Max Planck Institute for Human Cognitive and Brain Sciences
Department of Neurology
Stephanstraße 1A
Leipzig
04103
Germany
+49 7071 29-85736
lewis@cbs.mpg.de

Additional identifiers

EudraCT number

2019-003470-12

ClinicalTrials.gov number

Nil known

Protocol/serial number

NRO-080

Study information

Scientific title

Acute serotonergic modulation of intrinsic functional connectivity and function in brain regions and behaviors implicated in mood regulation - a pharmacological fMRI study in healthy volunteers

Acronym

SEROTONIN

Study hypothesis

Hypothesis 1: It is hypothesized that an acute serotonergic challenge has a large-scale impact on the intrinsic functional connectivity of most cortical and subcortical areas and is not limited to specific networks.

Hypothesis 2: It is hypothesized that an acute serotonergic challenge alters BOLD response in main areas of the reward system and explore, whether these early alterations affect only responses to punishment or responses to both reward and punishment.

Hypothesis 3: It is hypothesized that an acute serotonergic challenge alters BOLD response in amygdala and explore, whether this affects cognitive performance and emotional distraction.

Ethics approval

Approved 11/10/2010, Ethikkommission an der Medizinischen Fakultät der Universität Leipzig (ethics board of the Medical Faculty of the University of Leipzig, Käthe-Kollwitz-Straße 82, 04109 Leipzig, Germany; Tel: +49 (0)341/97 154 90; Email: ethik@medizin.uni-leipzig.de), ref: 246-2009-09112009

Study design

Single-centre double-blind placebo-controlled crossover study

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Other

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Effects of the antidepressant escitalopram in healthy volunteers

Intervention

The researchers administer a single oral dose of 20 mg escitalopram, a selective serotonin reuptake inhibitor (SSRI), or placebo to healthy participants in a double-blind, placebo-controlled, crossover design. Two treatment orders are randomly assigned to participants to ensure complete balancing of treatments. Escitalopram or placebo are administered at two different test days separated by a wash-out period of 8 weeks. At the first test day, participants undergo a baseline MRI scan before initial drug administration. For the drug MRI scans, the researchers measure participants 3-4 hours after drug administration, during peak concentration of escitalopram in blood. Scanning time is approx. 60 minutes per scan, consisting of structural MRI, resting state fMRI, and functional MRI (cognitive load task and reward task). Before each scan session, participants fill out questionnaires assessing depression (Hamilton Rating Scale for Depression) and mood (Profile of Mood states, and MOODS spectrum self-report).

Intervention type

Drug

Phase

Not Applicable

Drug names

Escitalopram

Primary outcome measure

Structural, functional, and resting-state MRI data measured during baseline, placebo, and drug sessions

Secondary outcome measures

1. Reward and punishment processing measured using a monetary reward task, which participants perform during the functional MRI scans at baseline, placebo, and drug sessions
2. Cognitive performance measured using a cognitive load task, which participants perform during the functional MRI scans at baseline, placebo, and drug sessions

Overall trial start date

11/10/2011

Overall trial end date

31/12/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. 20-30 years of age
2. Naive to antidepressants

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

20

Total final enrolment

24

Participant exclusion criteria

1. Current or past psychiatric diagnosis as assessed with SKID-I and SKID-II interview
2. Major head trauma or neurological disease, current or in history
3. Use of psychotropic medication or of recreational drugs
4. MRI contraindications such as metal implants, claustrophobia, pregnancy
5. Smoking
6. Irregular sleep/wake rhythm (e.g., regular nightshifts or cross timeline travel)

Recruitment start date

01/11/2011

Recruitment end date

30/04/2013

Locations

Countries of recruitment

Germany

Trial participating centre

Max Planck Institute for Human Cognitive and Brain Sciences
Stephanstrasse 1A
Leipzig
04103
Germany

Sponsor information

Organisation

Max Planck Institute for Human Cognitive and Brain Sciences

Sponsor details

Stephanstrasse 1A
Leipzig
04103
Germany
+49 341 9940-00
info@cbs.mpg.de

Sponsor type

Research organisation

Website

https://www.cbs.mpg.de/en

Funders

Funder type

Research organisation

Funder name

Max-Planck-Institut für Kognitions- und Neurowissenschaften

Alternative name(s)

Max Planck Institute for Human Cognitive and Brain Sciences, MPI for Human Cognitive and Brain Sciences

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Germany

Results and Publications

Publication and dissemination plan

The publication in the publications list includes the results of this study (results for hypothesis 1). Publication of the functional imaging results (hypothesis 2 and 3) is currently ongoing - planned publication in a high-impact peer-reviewed journal.

IPD sharing statement
The datasets generated during and/or analysed during the current study will be stored in a repository
Type of data: Statistic maps of functional connectivity analysis
Repository name: Neurovault.org
Weblink: https://identifiers.org/neurovault.collection:190
Process for requesting access: freely available
Consent from participants: Participants gave their consent that the results of this study will be published for scientific purposes.
Data anonymization: pseudonymised

Intention to publish date

01/06/2020

Participant level data

Stored in repository

Basic results (scientific)

Publication list

2014 results in https://www.ncbi.nlm.nih.gov/pubmed/25242032 (added 16/12/2019)

Publication citations

Additional files

Editorial Notes

16/12/2019: Trial's existence confirmed by ethics board of the Medical Faculty of the University of Leipzig.