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

July 9, 2018 updated by: BRC Operations Pty. Ltd.
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

2688

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Brain Dynamics Centre
    • South Australia
      • Adelaide, South Australia, Australia, 5042
        • Flinders University
    • Victoria
      • Melbourne, Victoria, Australia, 3181
        • The Alfred Hospital
      • Melbourne, Victoria, Australia, 3122
        • Swinburne University
  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6524 AD
        • Brainclinics Diagnostics B.V.
  • New Zealand
      • Auckland, New Zealand, 1142
        • University of Auckland
  • South Africa
    • Guatang
      • Johannesburg, Guatang, South Africa, 2191
        • Brain Health Lab
  • United States
    • California
      • Colton, California, United States, 92324
        • Shanti Clinical Trials
      • Mission Viejo, California, United States, 92691
        • A.D.D. Treatment Center
      • Stanford, California, United States, 94305
        • Stanford University
      • Stanford, California, United States, 94305
        • Veteran Affairs/Stanford University
      • Tarzana, California, United States, 91356
        • Center for Healing the Human Spirit
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami
    • Missouri
      • Saint Louis, Missouri, United States, 63121
        • University of Missouri - St. Louis
    • New Jersey
      • Englewood Cliffs, New Jersey, United States, 07632
        • Brain Resource Center
    • New York
      • New York, New York, United States, 10023
        • Brain Resource Center
      • White Plains, New York, United States, 10605
        • Weill Cornell Medical College
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Skyland Behavioral Health Associates , P.A.
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • NeuroDevelopment Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Escitalopram
Drug: Escitalopram
10 mg/day as a single dose, increased to max 20 mg/day
Other Names:
  • Lexapro
Active Comparator: B
Sertraline
Drug: Sertraline
50 mg/day as a single dose, increased to max of 200 mg/day
Other Names:
  • Zoloft
Active Comparator: C
Venlafaxine-XR
Drug: Venlafaxine-XR
75 mg/day given once daily; increased to 150-225 mg/day
Other Names:
  • Effexor
No Intervention: D
Healthy matched controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine whether the genetic-brain-cognition function markers (or combination of markers) 'normalise' with acute drug treatment in MDD
Time Frame: Week 8
Week 8

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine whether markers of acute treatment prediction are also predictive of functional outcome over 6-12 months.
Time Frame: 52-weeks
52-weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BRC Operations Pty. Ltd.

Investigators

  • Principal Investigator: Charles Debattista, MD, Stanford University
  • 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: 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
  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

June 6, 2008

First Submitted That Met QC Criteria

June 6, 2008

First Posted (Estimate)

June 9, 2008

Study Record Updates

Last Update Posted (Actual)

July 11, 2018

Last Update Submitted That Met QC Criteria

July 9, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • iSPOT-D

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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