International Study to Predict Optimised Treatment - in Depression

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.

Conditions

• Major Depressive Disorder

Interventions

DRUG

Escitalopram

10 mg/day as a single dose, increased to max 20 mg/day

DRUG

Sertraline

50 mg/day as a single dose, increased to max of 200 mg/day

DRUG

Venlafaxine-XR

75 mg/day given once daily; increased to 150-225 mg/day

Sponsors & Collaborators

• BRC Operations Pty. Ltd.

  lead INDUSTRY

Principal Investigators

• Anthony Harris, MD · Brain Dynamics Centre

• Barbara A. Cohen, PhD · Center for Healing the Human Spirit

• Bruce Russell, PhD · University of Auckland, New Zealand

• Charles Debattista, MD · Stanford University

• Con Stough, PhD · Swinburne University

• Elizabeth Wallis, PhD · Brain Health Lab

• Harbans Multani, MD · Shanti Clinical Trials

• Jayashri Kulkarni, Prof · The Alfred and Delmont Private Hospital

• Jeffrey Wilson, PhD · A.D.D. Treatment Center

• Kamran Fallahpour, PhD · Brain Resource Center

• Larry Hirshberg, PhD · NeuroDevelopment Center

• Martijn Arns, PhD · Brainclinics Diagnostics B.V.

• Mona Ismail, MD · Brain Resource Center

• Paul Fitzgerald, PhD · The Alfred

• Richard Clark, PhD · Flinders University

• Roger deBeus, PhD · Skyland Behavioral Health Associates

• Steven Bruce, PhD · University of Missouri, St. Louis

• Subhdeep Virk, MD · Ohio State University

• Tim Usherwood, MD · Brain Dynamics Centre

• XiaoLei Yu Baran, MD · Cornell University

• Radu V Saveanu, MD · University of Miami

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2008-09-30

Primary Completion

2019-12-31

Completion

2019-12-31

Countries

• United States
• Australia
• Netherlands
• New Zealand
• South Africa

Study Locations