Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000398303
Ethics application status
Approved
Date submitted
12/06/2008
Date registered
8/08/2008
Date last updated
22/06/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Wellness Study
Scientific title
Efficacy of low dose escitalopram v's placebo in the amelioration of anxiety and fatigue in patients who are unwell or suffer chronic illness
Secondary ID [1] 579 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic illness - patients who are generally unwell for an extended period. 3259 0
Condition category
Condition code
Other 3424 3424 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
0.05mg escitalopram oxalate in a lactose base in an opaque capsule. 1 capsule taken daily via oral route for a period of 6 weeks.
Intervention code [1] 3002 0
Treatment: Drugs
Comparator / control treatment
Lactose in an opaque capsule. 1 capsule taken daily via oral route for a period of 6 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 4319 0
Reduction in fatigue assessed by Fatigue Assessment Scale.
Timepoint [1] 4319 0
Screening and 6 weeks
Primary outcome [2] 4320 0
Reduction in anxiety assessed by Spielberger Questionnaire and Hospital Anxiety and Depression (HAD) Scale.
Timepoint [2] 4320 0
Baseline, screening and 6 weeks
Secondary outcome [1] 7744 0
Increase in effort tolerance as assessed by the Medical Research Council (MRC) Dyspnoea Scale.
Timepoint [1] 7744 0
Baseline, screening and 6 weeks

Eligibility
Key inclusion criteria
Chronic illness - patients who are generally unwell for an extended period.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with Malignancy or taking any prescribed antidepressant and/or pyschotrophic medication will be excluded from the trial.

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)
Allocation schedule held by separate party.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation table created by a computer based statistical program
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/01/2008
Actual
20/07/2007
Date of last participant enrolment
Anticipated
Actual
13/06/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
42
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 1051 0
6008

Funding & Sponsors
Funding source category [1] 3482 0
Charities/Societies/Foundations
Name [1] 3482 0
Mood Research Foundation (WA)
Country [1] 3482 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Mood Research Foundation (WA)
Address
Suite 4 336 Churchill Ave
SUBIACO WA 6008
Country
Australia
Secondary sponsor category [1] 3124 0
None
Name [1] 3124 0
Address [1] 3124 0
Country [1] 3124 0
Other collaborator category [1] 363 0
Individual
Name [1] 363 0
Dr Hans Stampfer
Address [1] 363 0
Sir Charles Gairdner Hospital
Hospital Ave
NEDLANDS WA 6009
Country [1] 363 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5513 0
St John of God Hospital Subiaco Campus
Ethics committee address [1] 5513 0
St John of God House
175 Cambridge St
SUBIACO WA 6008
Ethics committee country [1] 5513 0
Australia
Date submitted for ethics approval [1] 5513 0
Approval date [1] 5513 0
07/12/2006
Ethics approval number [1] 5513 0
133
Ethics committee name [2] 5759 0
St John of God Hospital Subiaco Campus
Ethics committee address [2] 5759 0
St John of God House
175 Cambridge St
SUBIACO WA 6008
Ethics committee country [2] 5759 0
Australia
Date submitted for ethics approval [2] 5759 0
Approval date [2] 5759 0
07/12/2006
Ethics approval number [2] 5759 0
133

Summary
Brief summary
The Wellness Study will evaluate 6 weeks of very low dose Escitalopram (50 micrograms) compared to placebo on fatigue, anxiety and depression in chronic medical illness. Following a 3 week baseline run in-phase, participants will be randomised 'double blind' to the active or placebo treatment, incorporating 4 study centre visits in all. Associated clinical benefits may include improvements in sleep, weight reduction, heart rate and blood pressure. Although serotonin re-uptake inhibitors have never previously been studied at such a low dose, clinical results to date appear encouraging.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28667 0
Prof Simon Dimmitt
Address 28667 0
Suite 304 25 McCourt St
SUBIACO WA 6008
Country 28667 0
Australia
Phone 28667 0
+61 8 63809585
Fax 28667 0
Email 28667 0
alicia@achf.org.au
Contact person for public queries
Name 11824 0
Prof Dr Simon Dimmitt
Address 11824 0
Suite 304
25 McCourt St
SUBIACO WA 6008
Country 11824 0
Australia
Phone 11824 0
08 9382 9580
Fax 11824 0
Email 11824 0
sdimmitt@bigpond.com
Contact person for scientific queries
Name 2752 0
Prof Dr Simon Dimmitt
Address 2752 0
Suite 304
25 McCourt St
SUBIACO WA 6008
Country 2752 0
Australia
Phone 2752 0
08 9382 9580
Fax 2752 0
Email 2752 0
sdimmitt@bigpond.com

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.