International Study to Predict Optimised Treatment - in Depression
Information source: BRC Operations Pty. Ltd.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Major Depressive Disorder
Intervention: Escitalopram (Drug); Sertraline (Drug); Venlafaxine-XR (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: BRC Operations Pty. Ltd. Official(s) and/or principal investigator(s): Anthony Harris, MD, Principal Investigator, Affiliation: Brain Dynamics Centre Barbara A. Cohen, PhD, Principal Investigator, Affiliation: Center for Healing the Human Spirit Bruce Russell, PhD, Principal Investigator, Affiliation: University of Auckland, New Zealand Charles Debattista, MD, Principal Investigator, Affiliation: Stanford University Con Stough, PhD, Principal Investigator, Affiliation: Swinburne University Elizabeth Wallis, PhD, Principal Investigator, Affiliation: Brain Health Lab Harbans Multani, MD, Principal Investigator, Affiliation: Shanti Clinical Trials Jayashri Kulkarni, Prof, Principal Investigator, Affiliation: The Alfred and Delmont Private Hospital Jeffrey Wilson, PhD, Principal Investigator, Affiliation: A.D.D. Treatment Center Kamran Fallahpour, PhD, Principal Investigator, Affiliation: Brain Resource Center Larry Hirshberg, PhD, Principal Investigator, Affiliation: NeuroDevelopment Center Martijn Arns, PhD, Principal Investigator, Affiliation: Brainclinics Diagnostics B.V. Mona Ismail, MD, Principal Investigator, Affiliation: Brain Resource Center Paul Fitzgerald, PhD, Principal Investigator, Affiliation: The Alfred Hospital Richard Clark, PhD, Principal Investigator, Affiliation: Flinders University Roger deBeus, PhD, Principal Investigator, Affiliation: Skyland Behavioral Health Associates Steven Bruce, PhD, Principal Investigator, Affiliation: University of Missouri, St. Louis Subhdeep Virk, MD, Principal Investigator, Affiliation: Ohio State University Tim Usherwood, MD, Principal Investigator, Affiliation: Brain Dynamics Centre XiaoLei Yu Baran, MD, Principal Investigator, Affiliation: Cornell University Radu V Saveanu, MD, Principal Investigator, Affiliation: University of Miami
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.
Clinical Details
Official title: International Study to Predict Optimised Treatment - in Depression
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Primary outcome: To determine whether the genetic-brain-cognition function markers (or combination of markers) 'normalise' with acute drug treatment in MDD
Secondary outcome: To determine whether markers of acute treatment prediction are also predictive of functional outcome over 6-12 months.
Detailed description:
This is an open-label, randomised (effectiveness) study (ie. comparison of active
treatments) to identify genetic markers, brain function, brain structure, and psychological
and cognitive indicators (or a combination of markers) in MDD subjects versus healthy
controls. Approximately 2,016 subjects with major depressive disorder (MDD) across multiple
international sites (USA, Canada, UK, South Africa, New Zealand, The Netherlands and
Australia) will be randomised to one of three approved and effective treatment arms:
Treatment A Escitalopram. Treatment B Sertraline. Treatment C Venlafaxine XR.
A group of matched healthy controls (n = 672) will also be enrolled.
Subjects will be asked to attend the testing facility on two separate occasions; for
Pre-treatment (Pre-Tx) and at 8 weeks post initiation of treatment. The
assessments/procedures at Pre-Tx and Week 8 include: Baseline a clinical work-up, blood
collection for genetic analyses, cognitive testing and electrical brain functioning
(EEG/ERP). Structural and functional data MRI data will be collected in ten percent (10%) of
participants.
On Day 4 and Weeks 2, 4, 6, 12, 16, 24 and 52 Subjects will be contacted by phone and asked
to complete 2 questionnaires via the internet.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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.
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.
Locations and Contacts
University of Auckland, Auckland 1142, New Zealand; Active, not recruiting
Shanti Clinical Trials, Colton, California 92324, United States; Completed
A.D.D. Treatment Center, Mission Viejo, California 92691, United States; Recruiting Jeffrey Wilson, PhD, Phone: 949-272-3870, Email: jwilson@addtreatmentcenters.org Jeffrey Wilson, Ph.D., Principal Investigator
Stanford University, Stanford, California 94305, United States; Active, not recruiting
Veteran Affairs/Stanford University, Stanford, California 94305, United States; Active, not recruiting
Center for Healing the Human Spirit, Tarzana, California 91356, United States; Completed
University of Miami, Miami, Florida 33136, United States; Recruiting Tania Guardia, Phone: 305-243-5563, Email: tguardia@med.miami.edu Radu V Saveanu, MD, Principal Investigator Patricia Junquera, MD, Principal Investigator
Brainclinics Diagnostics B.V., Nijmegen, Gelderland 6524 AD, Netherlands; Active, not recruiting
Brain Health Lab, Johannesburg, Guatang 2191, South Africa; Completed
University of Missouri - St. Louis, St. Louis, Missouri 63121, United States; Completed
Brain Resource Center, Englewood Cliffs, New Jersey 07632, United States; Completed
Brain Dynamics Centre, Westmead, New South Wales 2145, Australia; Active, not recruiting
Brain Resource Center, New York, New York 10023, United States; Completed
Weill Cornell Medical College, White Plains, New York 10605, United States; Recruiting XiaoLei Baran, Email: xyu@med.cornell.edu XiaoLei Yu Baran, MD, Principal Investigator
Skyland Behavioral Health Associates , P.A., Ashville, North Carolina 28801, United States; Completed
Ohio State University, Columbus, Ohio 43210, United States; Active, not recruiting
NeuroDevelopment Center, Providence, Rhode Island 02903, United States; Completed
Flinders University, Adelaide, South Australia 5042, Australia; Completed
Delmont Private Hospital, Glen Iris, Victoria 3146, Australia; Withdrawn
Swinburne University, Melbourne, Victoria 3122, Australia; Active, not recruiting
The Alfred Hospital, Melbourne, Victoria 3181, Australia; Recruiting Mirjana Stojkovic, Phone: +61 (0)3 90766589, Email: mirjana.stojkovic@monash.edu Paul Fitzgerald, MD, Principal Investigator Jayashri Kulkarni, Prof, Principal Investigator
Additional Information
Australian New Zealand Clinical Trials Registry
Starting date: September 2008
Last updated: May 7, 2015
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