ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

U1111-1122-8682

Trial acronym

None

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Depression

Anxiety

Condition category

Condition code

Mental Health

Depression

Mental Health

Anxiety

Mental Health

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]

Treatment: Drugs

Comparator / control treatment

Placebo (saccharin, single oral dose)

Control group

Placebo

Outcomes

Primary outcome [1]

Functional magnetic resonance imaging (fMRI) blood-oxygen level dependent (BOLD) responses during viewing of emotional images.

Timepoint [1]

At peak drug blood concentration (3-4 hours after administration).

Primary outcome [2]

Electroencephalogram (EEG) alpha asymmetry and heart rate variability (HRV) during rest and a stress test.

Timepoint [2]

At peak drug blood concentration (3-4 hours after administration).

Secondary outcome [1]

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]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

2065

Recruitment postcode(s) [2]

2008

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Australian Research Council

Address [1]

1st Floor, 8 Briadabella Circuit
Briadabella Business Park
Canberra Airport ACT 2609

Country [1]

Australia

Primary sponsor type

University

Name

The University of Sydney

Address

The University of Sydney NSW 2006

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Hospital

Name [1]

Royal North Shore Hospital

Address [1]

Royal North Shore Hospital
St Leonards NSW 2065

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern Sydney Central Coast NSW Health Human Research Ethics Committee

Ethics committee address [1]

Research Office
Level 2, Building 51
Royal North Shore Hospital
St Leonards NSW 2065

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

17/05/2011

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Tim Outhred

Address

CADE Clinic
Level 5, Building 36 Royal North Shore Hospital
St Leonards NSW 2065

Country

Australia

Phone

+61 2 99267746

Fax

+61 2 99267730

tout1075@uni.sydney.edu.au

Contact person for scientific queries

Name

Tim Outhred

Address

CADE Clinic
Level 5, Building 36 Royal North Shore Hospital
St Leonards NSW 2065

Country

Australia

Phone

+61 2 99267746

Fax

+61 2 99267730

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

Source	Title	Year of Publication	DOI
Dimensions AI	Impact of acute administration of escitalopram on the processing of emotional and neutral images: a randomized crossover fMRI study of healthy women	2014	https://doi.org/10.1503/jpn.130118
Dimensions AI	The impact of 5-HTTLPR on acute serotonin transporter blockade by escitalopram on emotion processing: Preliminary findings from a randomised, crossover fMRI study	2014	https://doi.org/10.1177/0004867414533837
Embase	Facilitation of emotion regulation with a single dose of escitalopram: A randomized fMRI study.	2015	https://dx.doi.org/10.1016/j.pscychresns.2015.07.018
Embase	Impact of 5-HTTLPR on SSRI serotonin transporter blockade during emotion regulation: A preliminary fMRI study.	2016	https://dx.doi.org/10.1016/j.jad.2016.02.019

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically