Trial from ANZCTR


Trial ID ACTRN12611000719932
Trial Status: Registered
Date Submitted: 11/07/2011
Date Registered: 11/07/2011
Prospectively registered

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Public title The impact of antidepressants and genetic polymorphisms on emotion.
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format Impact of Escitalopram and Serotonin Transporter Polymorphisms on Emotion Processing and Regulation In Healthy Participants: A Randomised Controlled Trial
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Secondary ID [1] 262602 0
None
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UTN U1111-1122-8682
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Trial acronym None
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Health condition(s) or problem(s) studied:
Depression 268294 0
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Anxiety 268295 0
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Condition category: Condition code:
Mental Health Depression
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Mental Health Anxiety
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Mental Health Studies of normal psychology, cognitive function and behaviour
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Descriptions of intervention(s) / exposure Escitalopram (single oral dose, 20mg)
crossed over with Placebo (saccharin, single oral dose) with a washout period of 7 days.
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Treatment: drugs 266944 0
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Comparator / control treatment Placebo (saccharin, single oral dose)
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Control group Placebo
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Primary Outcome: Functional magnetic resonance imaging (fMRI) blood-oxygen level dependent (BOLD) responses during viewing of emotional images. 269179 0
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Timepoint: At peak drug blood concentration (3-4 hours after administration). 269179 0
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Primary Outcome: Electroencephalogram (EEG) alpha asymmetry and heart rate variability (HRV) during rest and a stress test. 269181 0
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Timepoint: At peak drug blood concentration (3-4 hours after administration). 269181 0
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Secondary Outcome: 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. 279075 0
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Timepoint: Before administration of treatment and at peak drug blood concentration (3-4 hours after administration) 279075 0
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Key inclusion criteria Female
Aged 18-50
Caucasian (if recruitment is slow, we will remove this criterion)
Fluent in English
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Minimum age 18 Years
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Maximum age 50 Years
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Gender Females
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Healthy volunteers? Yes
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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).
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Study type Interventional
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Purpose of the study Treatment
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Allocation to intervention Randomised controlled trial
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Describe the 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.
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Describe the 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.
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Masking / blinding Blinded (masking used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Crossover
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Other design features
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Type of endpoint(s) Efficacy
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Statistical Methods/Analysis
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Phase Phase 4
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Anticipated date of first participant enrolment 19/07/2011
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 50
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Recruitment status Completed
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Recruitment in Australia

Recruitment state(s)
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Postcode: 2065 4231 0
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Postcode: 2008 4232 0
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Recruitment outside Australia

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Funding Source: Government body 267414 0
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Name: Australian Research Council 267414 0
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Address: 1st Floor, 8 Briadabella Circuit
Briadabella Business Park
Canberra Airport ACT 2609
267414 0
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Country: Australia 267414 0
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Primary Sponsor University
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Name: The University of Sydney
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Address: The University of Sydney NSW 2006
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Country: Australia
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Secondary Sponsor: None 266468 0
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Other Collaborator: Hospital 252104 0
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Name: Royal North Shore Hospital 252104 0
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Address: Royal North Shore Hospital
St Leonards NSW 2065
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Country: Australia 252104 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: Northern Sydney Central Coast NSW Health Human Research Ethics Committee 269382 0
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Address: Research Office
Level 2, Building 51
Royal North Shore Hospital
St Leonards NSW 2065
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Country: Australia 269382 0
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Approval Date: 17/05/2011 269382 0
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Submitted Date: 269382 0
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HREC: 1101-027M 269382 0
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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.
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Trial website
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Public Notes
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Principal Investigator
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Contact person for public queries
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Name: Tim Outhred
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Address: CADE Clinic Level 5, Building 36 Royal North Shore Hospital St Leonards NSW 2065
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Country: Australia
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Tel: +61 2 99267746
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Email: tout1075@uni.sydney.edu.au
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Contact person for scientific queries
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Name: Tim Outhred
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Address: CADE Clinic Level 5, Building 36 Royal North Shore Hospital St Leonards NSW 2065
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Contact person responsible for updating information
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Name: Tim Outhred
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Address: CADE Clinic Level 5, Building 36 Royal North Shore Hospital St Leonards NSW 2065
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Country: Australia
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Addition Cancer fields
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