Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12609000011280
Ethics application status
Approved
Date submitted
1/08/2008
Date registered
8/01/2009
Date last updated
4/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Sub-chronic administration of the selective serotonin reuptake inhibitor escitalopram in healthy volunteers: drug initiation effects and the role of serotonin in experimental anxiety.
Scientific title
The effect in healthy volunteers of administration of the selective serotonin reuptake inhibitor escitalopram (10 mg/day for 3 weeks) vs. placebo on drug initiation effects and experimentally-induced anxiety.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anxiety 3494 0
selective serotonin reuptake inhibitor (SSRI) initiation effects 3495 0
Condition category
Condition code
Mental Health 3649 3649 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
escitalopram (10 mg/day for 3 weeks, oral)
tryptophan depletion
Intervention code [1] 3216 0
Treatment: Other
Comparator / control treatment
placebo (sugar capsule, 3 weeks, oral)
Control group
Placebo

Outcomes
Primary outcome [1] 4550 0
Change in the Spielberger State Anxiety Inventory in the placebo and escitalopram groups
Timepoint [1] 4550 0
pre and post tryptophan depletion
Primary outcome [2] 4551 0
Change in Visual Analogue Scale scores (anxiety, nervous) in the placebo and escitalopram groups
Timepoint [2] 4551 0
pre and post tryptophan depletion
Secondary outcome [1] 7701 0
Spielberger state anxiety Inventory
Timepoint [1] 7701 0
pre-drug, 3 days, 1 week, 2 weeks and 3 weeks post drug initiation

Eligibility
Key inclusion criteria
healthy volunteer
no current or previous history of anxiety, depression or mental illness
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
current or past mental illness
current or past use of SSRI medication
pregnant/breastfeeding
serious medical condition
history of head injury
history of drug abuse/dependence

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)
Participants are screened by study doctors. Once deemed eligible to participate, they will be assigned a study number that corresponds to study medication bottles.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
placebo and escitalopram order randomly assigned in blocks using a random number generator (www.random.org)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/08/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
28
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3673 0
University
Name [1] 3673 0
University of Western Australia Small Grants Scheme 2007
Country [1] 3673 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
35 Stirling Hwy
Nedlands, WA, 6009
Country
Australia
Secondary sponsor category [1] 3298 0
None
Name [1] 3298 0
Address [1] 3298 0
Country [1] 3298 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5726 0
UWA HREC
Ethics committee address [1] 5726 0
35 Stirling Hwy
Nedlands, WA, 6009
Ethics committee country [1] 5726 0
Australia
Date submitted for ethics approval [1] 5726 0
Approval date [1] 5726 0
26/05/2008
Ethics approval number [1] 5726 0
RA/1/4/1984

Summary
Brief summary
The purpose of this study is to investigate whether the effect of selective serotonin reuptake inhibitors seen when used to treat anxiety are related to the drug, or to the fact that the people have an anxiety disorder. We expect that we will see "jitteriness" when healthy volunteers start taking the medication, and that the medication will reduce anxiety brought on by an experimental challenge in people who do not have an anxiety disorder.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28800 0
Address 28800 0
Country 28800 0
Phone 28800 0
Fax 28800 0
Email 28800 0
Contact person for public queries
Name 11957 0
Dr Sean Hood
Address 11957 0
School of Psychiatry and Clinical Neurosciences
35 Stirling Hwy
Nedlands, WA, 6009
Country 11957 0
Australia
Phone 11957 0
+61 8 9346 2393
Fax 11957 0
Email 11957 0
[email protected]
Contact person for scientific queries
Name 2885 0
Dr Sean Hood
Address 2885 0
School of Psychiatry and Clinical Neurosciences
35 Stirling Hwy
Nedlands, WA, 6009
Country 2885 0
Australia
Phone 2885 0
+61 8 9346 2393
Fax 2885 0
Email 2885 0
[email protected]

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
No additional documents have been identified.