International Study to Predict Optimised Treatment - in Depression (iSPOT-D)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by BRC Operations Pty. Ltd.
Sponsor:
Information provided by (Responsible Party):
BRC Operations Pty. Ltd.
ClinicalTrials.gov Identifier:
NCT00693849
First received: June 6, 2008
Last updated: June 7, 2013
Last verified: June 2013

June 6, 2008
June 7, 2013
September 2008
April 2014   (final data collection date for primary outcome measure)
To determine whether the genetic-brain-cognition function markers (or combination of markers) 'normalise' with acute drug treatment in MDD [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00693849 on ClinicalTrials.gov Archive Site
To determine whether markers of acute treatment prediction are also predictive of functional outcome over 6-12 months. [ Time Frame: 52-weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
International Study to Predict Optimised Treatment - in Depression
International Study to Predict Optimised Treatment - in Depression

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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Major Depressive Disorder
  • Drug: Escitalopram
    10 mg/day as a single dose, increased to max 20 mg/day
    Other Name: Lexapro
  • Drug: Sertraline
    50 mg/day as a single dose, increased to max of 200 mg/day
    Other Name: Zoloft
  • Drug: Venlafaxine XR
    75 mg/day given once daily; increased to 150-225 mg/day
    Other Name: Effexor
  • Active Comparator: A
    Escitalopram
    Intervention: Drug: Escitalopram
  • Active Comparator: B
    Sertraline
    Intervention: Drug: Sertraline
  • Active Comparator: C
    Venlafaxine
    Intervention: Drug: Venlafaxine XR
  • No Intervention: D
    Healthy matched controls

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2688
February 2015
April 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
Yes
United States,   Australia,   Netherlands,   New Zealand,   South Africa
 
NCT00693849
iSPOT-D
No
BRC Operations Pty. Ltd.
BRC Operations Pty. Ltd.
Not Provided
Principal Investigator: Anthony Harris, MD Brain Dynamics Centre
Principal Investigator: Barbara A. Cohen, PhD Center for Healing the Human Spirit
Principal Investigator: Bruce Russell, PhD University of Auckland, New Zealand
Principal Investigator: Charles Debattista, MD Stanford University
Principal Investigator: Con Stough, PhD Swinburne University
Principal Investigator: Elizabeth Wallis, PhD Brain Health Lab
Principal Investigator: Harbans Multani, MD Shanti Clinical Trials
Principal Investigator: Jayashri Kulkarni, Prof The Alfred and Delmont Private Hospital
Principal Investigator: Jeffrey Wilson, PhD A.D.D. Treatment Center
Principal Investigator: Kamran Fallahpour, PhD Brain Resource Center
Principal Investigator: Larry Hirshberg, PhD NeuroDevelopment Center
Principal Investigator: Martijn Arns, PhD Brainclinics Diagnostics B.V.
Principal Investigator: Mona Ismail, MD Brain Resource Center
Principal Investigator: Paul Fitzgerald, PhD The Alfred Hospital
Principal Investigator: Richard Clark, PhD Flinders University
Principal Investigator: Roger deBeus, PhD Skyland Behavioral Health Associates
Principal Investigator: Steven Bruce, PhD University of Missouri, St. Louis
Principal Investigator: Subhdeep Virk, MD Ohio State University
Principal Investigator: Tim Usherwood, MD Brain Dynamics Centre
Principal Investigator: XiaoLei Yu Baran, MD Cornell University
Principal Investigator: Radu V Saveanu, MD University of Miami
BRC Operations Pty. Ltd.
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP