Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000476336
Ethics application status
Approved
Date submitted
27/05/2008
Date registered
24/09/2008
Date last updated
19/07/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
International Study to Predict Optimized Treatment - in Depression
Scientific title
International Study to Predict Optimized Treatment response to the three most commonly used antidepressants (Escitalopram, Sertraline and Venlafaxine extended release XR,) in subjects diagnosed with major depressive disorder (MDD) as compared to matched healthy controls.
Universal Trial Number (UTN)
Trial acronym
iSPOT-D
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder (MDD) 2765 0
Condition category
Condition code
Mental Health 2917 2917 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Once randomised and on drug, subjects will be dosed with study medication as per local/country standard of care. Therefore, the length of treatment will differ and is based on the subjects response.

escitalopram one 10 mg tablet orally once daily (QD)
sertraline one 50 mg orally QD
venlafaxine extended release (XR) one 75 mg orally QD
Intervention code [1] 2925 0
Treatment: Other
Comparator / control treatment
matched healthy subjects not taking medication
Control group
Historical

Outcomes
Primary outcome [1] 3796 0
Composite markers from 165 different assessments/variables will be assessed to identify genetic, brain structure/function and cognitive markers (or combination of markers) which predict acute drug treatment response in MDD. This will be assessed using:

The MINI International Neuropsychatric Interview.
Hamilton Rating of Depression Scale (HAM-D21).
Web based questionnaire (web-Q), including:
Depression, Anxiety and Stress Scale (DASS42).
Neuroticism, Extraversion, and Openness Five Factor Inventory (NEO-FFI).
Emotion Regulation Questionnaire (ERQ).
Satisfaction with Life Scale (SWLS).
Quick Inventory of Depressive Symptomatology (QIDS-SR)
CORE Rating Scale
Columbia Atypical Depression Diagnostic Scale (ADDS)
Visual Analogue Scale for both physical and psychological pain
Clinical Global Impression (CGI)
26-item World Health Organisation Quality of Life Scale Brief Version (The WHOQOL)
Social and Occupational Functioning Assessment Scale (SOFAS)
Self Rated Global measure of the Frequency, Intensity and Burden of Side Effects Rating (FIBSER).

Psychophysiological assessment (including, respiratory rate, sweat rate, EEG and Event Related Potential) and a Cognitive test battery.
Symptom and sub-type assessment.
Full Genetic array analysis.
Structural and functional MRI.
Timepoint [1] 3796 0
Week 8
Secondary outcome [1] 6407 0
To determine whether markers of acute treatment prediction are also predictive of functional outcome over 6-12 months. Using Quick Inventory of Depressive Symptomatology (QIDS) and the Self Rated Global measure of the Frequency, Intensity and Burden of Side Effects Rating (FIBSER).
Timepoint [1] 6407 0
Week 52

Eligibility
Key inclusion criteria
Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)criteria for primary Major Depressive Disorder with a Hamilton Rating Depression Scale (HAM-D) score >/= 16 and who are fluent in English or Dutch.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Presence of suicidal ideations, biopoloar, psychosis or primary eating disorder.
Prior or resent use antidepressants including escitalopram, sertraline, venlafaxine XR.
History of brain injury/blow resulting in loss of consciousness.
evere impediment to vision, hearing and/or hand movement which may interfere with their ability to complete the protocol required test.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Study staff to contact an interactive web randomisation system.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/07/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
2688
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 875 0
2145
Recruitment postcode(s) [2] 876 0
3122
Recruitment postcode(s) [3] 877 0
5042
Recruitment outside Australia
Country [1] 761 0
United States of America
State/province [1] 761 0
Missouri
Country [2] 762 0
United States of America
State/province [2] 762 0
California
Country [3] 763 0
United States of America
State/province [3] 763 0
New York
Country [4] 764 0
United States of America
State/province [4] 764 0
Rhode Island
Country [5] 765 0
United States of America
State/province [5] 765 0
North Carolina
Country [6] 766 0
New Zealand
State/province [6] 766 0
Auckland
Country [7] 767 0
Netherlands
State/province [7] 767 0
Nijmegen

Funding & Sponsors
Funding source category [1] 3043 0
Commercial sector/Industry
Name [1] 3043 0
Brain Resource
Country [1] 3043 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Brain Resource
Address
Level 12, 235 Jones Street
Ultimo, NSW 2007
Country
Australia
Secondary sponsor category [1] 2742 0
None
Name [1] 2742 0
Address [1] 2742 0
Country [1] 2742 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5450 0
The Copernicus Group IRB
Ethics committee address [1] 5450 0
Ethics committee country [1] 5450 0
United States of America
Date submitted for ethics approval [1] 5450 0
Approval date [1] 5450 0
07/05/2008
Ethics approval number [1] 5450 0
Ethics committee name [2] 5708 0
SWAHS
Ethics committee address [2] 5708 0
Ethics committee country [2] 5708 0
Australia
Date submitted for ethics approval [2] 5708 0
Approval date [2] 5708 0
14/07/2008
Ethics approval number [2] 5708 0
HREC2008/4/4.17 (2726)

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28329 0
Address 28329 0
Country 28329 0
Phone 28329 0
Fax 28329 0
Email 28329 0
Contact person for public queries
Name 11486 0
Mimma Mason
Address 11486 0
Level 12, 235 Jones Street
Ultimo, NSW 2007
Country 11486 0
Australia
Phone 11486 0
+61 (0)2 9211 7120
Fax 11486 0
Email 11486 0
[email protected]
Contact person for scientific queries
Name 2414 0
Patrick Hopkinson
Address 2414 0
Level 12, 235 Jones Street
Ultimo, NSW 2007
Country 2414 0
Australia
Phone 2414 0
+61 (0)2 9211 7120
Fax 2414 0
Email 2414 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.