International Study to Predict Optimised Treatment - in Depression

Status unconfirmed · Phase 4

Conditions studied: Major Depressive Disorder

In brief

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.

Key facts

Study ID

NCT00693849

Run by

BRC Operations Pty. Ltd.

People needed

2688

Starts

2008-09-01

Expected to finish

2019-12-01

Last updated by the study team

2018-07-11

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Shanti Clinical Trials — Colton, California, United States
• A.D.D. Treatment Center — Mission Viejo, California, United States
• Stanford University — Stanford, California, United States
• Veteran Affairs/Stanford University — Stanford, California, United States
• Center for Healing the Human Spirit — Tarzana, California, United States
• University of Miami — Miami, Florida, United States
• University of Missouri - St. Louis — St Louis, Missouri, United States
• Brain Resource Center — Englewood Cliffs, New Jersey, United States
• Brain Resource Center — New York, New York, United States
• Weill Cornell Medical College — White Plains, New York, United States
• Skyland Behavioral Health Associates , P.A. — Asheville, North Carolina, United States
• Ohio State University — Columbus, Ohio, United States
• NeuroDevelopment Center — Providence, Rhode Island, United States
• Brain Dynamics Centre — Westmead, New South Wales, Australia
• Flinders University — Adelaide, South Australia, Australia
• Swinburne University — Melbourne, Victoria, Australia
• The Alfred Hospital — Melbourne, Victoria, Australia
• Brainclinics Diagnostics B.V. — Nijmegen, Gelderland, Netherlands
• University of Auckland — Auckland, New Zealand
• Brain Health Lab — Johannesburg, Guatang, South Africa

Full record on ClinicalTrials.gov

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