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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00693849




Registration number
NCT00693849
Ethics application status
Date submitted
6/06/2008
Date registered
9/06/2008
Date last updated
11/07/2018

Titles & IDs
Public title
International Study to Predict Optimised Treatment - in Depression
Scientific title
International Study to Predict Optimised Treatment - in Depression
Secondary ID [1] 0 0
iSPOT-D
Universal Trial Number (UTN)
Trial acronym
iSPOT-D
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Escitalopram
Treatment: Drugs - Sertraline
Treatment: Drugs - Venlafaxine-XR

Active Comparator: A - Escitalopram

Active Comparator: B - Sertraline

Active Comparator: C - Venlafaxine-XR

No Intervention: D - Healthy matched controls


Treatment: Drugs: Escitalopram
10 mg/day as a single dose, increased to max 20 mg/day

Treatment: Drugs: Sertraline
50 mg/day as a single dose, increased to max of 200 mg/day

Treatment: Drugs: Venlafaxine-XR
75 mg/day given once daily; increased to 150-225 mg/day

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To determine whether the genetic-brain-cognition function markers (or combination of markers) 'normalise' with acute drug treatment in MDD
Timepoint [1] 0 0
Week 8
Secondary outcome [1] 0 0
To determine whether markers of acute treatment prediction are also predictive of functional outcome over 6-12 months.
Timepoint [1] 0 0
52-weeks

Eligibility
Key inclusion criteria
- Meet DSM-IV criteria for primary diagnosis of MDD.

- HAM-D17 score of = 16.

- 18-65 years age-range

- Subjects with English or Dutch literacy and fluency.

- Written, informed consent.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Presence of suicidal ideations and/or tendencies (as determined by a score >12 on
Section C, Suicidality, of the MINI Plus), Bipolar I-III, psychosis, primary eating
disorders, Post Traumatic Stress Disorder (PTSD), Obsessive Compulsive Disorder (OCD),
Post-Natal Depression as well as any Axis II personality disorders as diagnosed using
the MINI Plus or by a health care professional.

- Pregnancy and women of child bearing potential who are not taking a medically accepted
form of contraception and are at risk of becoming pregnant during the study.

- Breastfeeding.

- Known contra-indication or intolerance to the use of Escitalopram, Sertraline or
Venlafaxine XR as defined in the product package insert for each drug (including
previous treatment failure at the highest recommended dose).

- Use of any psychological or counselling therapy or antidepressant/CNS drug which
cannot be washed out prior to participation and eliminated until after Week 8 or
discontinuation.

- Use of any medication which is known to be contraindicated with Escitalopram,
Sertraline, or Venlafaxine XR (refer to the product package insert for each drug).

- Known medical condition, disease or neurological disorder which might, in the opinion
of investigator/s, interfere with the assessments to be made in the study or put
subjects at increased risk when exposed to optimal doses of the drug treatment.

- History of head injury with loss of consciousness for at least 10 minutes.

- Recent/current substance dependence (as defined in Section K of the Mini Plus as per a
6 months period and/or alcoholism) in the past six months.

- Participation in an investigational study within four months of the baseline visit in
which subjects have received an experimental drug/device that could affect the primary
end points of this study.

- Subjects who, in the opinion of the investigator, have a severe impediment to vision,
hearing and/or hand movement, which is likely to interfere with their ability to
complete the test batteries.

- Subjects who, in the opinion of the investigator, are unable and/or unlikely to
comprehend and follow the study procedures and instructions.

Study design
Purpose of the study
Health Services Research
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
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)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Brain Dynamics Centre - Westmead
Recruitment hospital [2] 0 0
Flinders University - Adelaide
Recruitment hospital [3] 0 0
Swinburne University - Melbourne
Recruitment hospital [4] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
5042 - Adelaide
Recruitment postcode(s) [3] 0 0
3122 - Melbourne
Recruitment postcode(s) [4] 0 0
3181 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Missouri
Country [4] 0 0
United States of America
State/province [4] 0 0
New Jersey
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Rhode Island
Country [9] 0 0
Netherlands
State/province [9] 0 0
Gelderland
Country [10] 0 0
New Zealand
State/province [10] 0 0
Auckland
Country [11] 0 0
South Africa
State/province [11] 0 0
Guatang

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
BRC Operations Pty. Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The aim of this study is to identify genetic, physical (brain) and psychological (cognitive)
markers (or combinations of them) that predict specific response to a range of
antidepressants treatment (Escitalopram, Venlafaxine, Sertraline) in patients diagnosed with
major depressive disorder. This study is focused on outcomes which may impact on how
"personalised medicine" is implemented in depression.
Trial website
https://clinicaltrials.gov/show/NCT00693849
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Anthony Harris, MD
Address 0 0
Brain Dynamics Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00693849