Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000719932
Ethics application status
Approved
Date submitted
11/07/2011
Date registered
11/07/2011
Date last updated
8/10/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of antidepressants and genetic polymorphisms on emotion.
Scientific title
Impact of Escitalopram and Serotonin Transporter Polymorphisms on Emotion Processing and Regulation In Healthy Participants: A Randomised Controlled Trial
Secondary ID [1] 262602 0
None
Universal Trial Number (UTN)
U1111-1122-8682
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 268294 0
Anxiety 268295 0
Condition category
Condition code
Mental Health 268426 268426 0 0
Depression
Mental Health 268427 268427 0 0
Anxiety
Mental Health 268428 268428 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Escitalopram (single oral dose, 20mg)
crossed over with Placebo (saccharin, single oral dose) with a washout period of 7 days.
Intervention code [1] 266944 0
Treatment: Drugs
Comparator / control treatment
Placebo (saccharin, single oral dose)
Control group
Placebo

Outcomes
Primary outcome [1] 269179 0
Functional magnetic resonance imaging (fMRI) blood-oxygen level dependent (BOLD) responses during viewing of emotional images.
Timepoint [1] 269179 0
At peak drug blood concentration (3-4 hours after administration).
Primary outcome [2] 269181 0
Electroencephalogram (EEG) alpha asymmetry and heart rate variability (HRV) during rest and a stress test.
Timepoint [2] 269181 0
At peak drug blood concentration (3-4 hours after administration).
Secondary outcome [1] 279075 0
No expected differences or changes overtime on Depression, Anxiety and Stress Scales; Patient Health Questionnaire; GAD7 anxiety questionnaire; Early life stress; Ratings of emotional images for escitalopram or placebo conditions.
Timepoint [1] 279075 0
Before administration of treatment and at peak drug blood concentration (3-4 hours after administration)

Eligibility
Key inclusion criteria
Female
Aged 18-50
Caucasian (if recruitment is slow, we will remove this criterion)
Fluent in English
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Not on any medication (minimum 1 month drug-free; with the exception of the contraceptive pill) or illicit drugs.
Pregnancy (which will be tested at each visit)
Breastfeeding
Drug or alcohol addiction
A history of brain injury, loss of consciousness, stroke, psychiatric, neurological disorder or other serious medical conditions (e.g., cardiovascular disease and diabetes).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects will contact the investigators after viewing an advertisement on a University's recruitment website, a poster, or a social media advertisement.

Allocation was conducted by an independent statistician and concealed using opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An independent statistician generated a computerised spreadsheet which randomly allocated (using block randomisation) for 25 subjects to have the escitalopram on the first visit and 25 subjects having the placebo first. This spreadsheet was then sent to the pharmacy who then manufactured identical capsules which are then provided to and administered by the investigators. Only the pharmacist will know what each participant received.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/07/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4232 0
2008
Recruitment postcode(s) [2] 4231 0
2065

Funding & Sponsors
Funding source category [1] 267414 0
Government body
Name [1] 267414 0
Australian Research Council
Country [1] 267414 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney NSW 2006
Country
Australia
Secondary sponsor category [1] 266468 0
None
Name [1] 266468 0
Address [1] 266468 0
Country [1] 266468 0
Other collaborator category [1] 252104 0
Hospital
Name [1] 252104 0
Royal North Shore Hospital
Address [1] 252104 0
Royal North Shore Hospital
St Leonards NSW 2065
Country [1] 252104 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269382 0
Northern Sydney Central Coast NSW Health Human Research Ethics Committee
Ethics committee address [1] 269382 0
Research Office
Level 2, Building 51
Royal North Shore Hospital
St Leonards NSW 2065
Ethics committee country [1] 269382 0
Australia
Date submitted for ethics approval [1] 269382 0
Approval date [1] 269382 0
17/05/2011
Ethics approval number [1] 269382 0
1101-027M

Summary
Brief summary
Selective serotonin reuptake inhibitors (SSRIs) are a type of medication and are a first line treatment for major depression and anxiety. While recent studies have shown that neuroimaging and genetics may be used to predict response to SSRI treatment, (see Kemp, Gordon, Rush, & Willams, 2008 for review) basic experimental research is needed to determine exactly how the effects of SSRIs improve symptoms of depression and anxiety.
Acute administration of SSRIs may increase processing of positive emotional information, providing a foundation for subsequent changes in thoughts and behaviour (see Harmer, 2008). In order to examine this further, a number of critical issues remain to be addressed. One such issue is the serotonin transporter (5­HTT) gene. The different forms of this gene (5­HTT polymorphisms; l/l, l/s, or s/s alleles) have been reported to moderate the impact of SSRIs on emotion perception (Hinkelmann et al., 2010). However, researchers are yet to examine the interacting roles of SSRIs and the 5­HTT polymorphisms on emotional processing in real­time. A second issue is that researchers are yet to account for the different types of emotional processing and emotion regulation strategies under different conditions.
Aims: The aims of this study are to examine the impact of acute administration of an SSRI (escitalopram oxalate) and 5­HTT polymorphisms on covert and overt emotion processing and strategies to regulate this processing. Participants: 50 students will be recruited from first year Psychology students, genotyped and scanned under placebo and escitalopram conditions using a randomised controlled design. Given 5­HTT polymorphisms frequencies of 30% (l/l), 50% (l/s), and 20% (s/s) it is expected that a minimum of 15 participants homozygous for the L ­allele and 35 participants with at least one copy of the S ­allele will be recruited.
Treatment: Administration of escitalopram oxalate (20mg) or placebo (saccharin, an artificial sweetener). Participants will complete experimental tasks once peak absorption has been reached. One week later (for compete elimination of drug), participants will be administered the alternate treatment and complete the experimental tasks once again. Tasks: Data will be collected using functional magnetic resonance imaging (fMRI) during rest, covert and overt emotion processing of different images from the International Affective Picture System. Participants will be asked to either passively view or reappraise emotions evoked by the presented stimuli. Questionnaires: Depression, Anxiety and Stress Scales; Patient Health Questionnaire; GAD­7 anxiety questionnaire; Early life stress; Ratings of emotional images Experimental Design: 2 Group (5­HTT s­allele, l­allele) X 2 (escitalopram oxalate, placebo) within­-subject design.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32858 0
Address 32858 0
Country 32858 0
Phone 32858 0
Fax 32858 0
Email 32858 0
Contact person for public queries
Name 16105 0
Tim Outhred
Address 16105 0
CADE Clinic
Level 5, Building 36 Royal North Shore Hospital
St Leonards NSW 2065
Country 16105 0
Australia
Phone 16105 0
+61 2 99267746
Fax 16105 0
+61 2 99267730
Email 16105 0
tout1075@uni.sydney.edu.au
Contact person for scientific queries
Name 7033 0
Tim Outhred
Address 7033 0
CADE Clinic
Level 5, Building 36 Royal North Shore Hospital
St Leonards NSW 2065
Country 7033 0
Australia
Phone 7033 0
+61 2 99267746
Fax 7033 0
+61 2 99267730
Email 7033 0
tout1075@uni.sydney.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseFacilitation of emotion regulation with a single dose of escitalopram: A randomized fMRI study.2015https://dx.doi.org/10.1016/j.pscychresns.2015.07.018
EmbaseImpact of 5-HTTLPR on SSRI serotonin transporter blockade during emotion regulation: A preliminary fMRI study.2016https://dx.doi.org/10.1016/j.jad.2016.02.019
Dimensions AIImpact of acute administration of escitalopram on the processing of emotional and neutral images: a randomized crossover fMRI study of healthy women2014https://doi.org/10.1503/jpn.130118
Dimensions AIThe impact of 5-HTTLPR on acute serotonin transporter blockade by escitalopram on emotion processing: Preliminary findings from a randomised, crossover fMRI study2014https://doi.org/10.1177/0004867414533837
N.B. These documents automatically identified may not have been verified by the study sponsor.