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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


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.


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

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