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

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ClinicalTrials.gov Identifier: NCT00693849
Recruitment Status : Recruiting
First Posted : June 9, 2008
Last Update Posted : January 23, 2017
Information provided by (Responsible Party):
BRC Operations Pty. Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Escitalopram Drug: Sertraline Drug: Venlafaxine-XR Phase 4

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  (Clinical Trial)
Estimated Enrollment : 2688 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: International Study to Predict Optimised Treatment - in Depression
Study Start Date : September 2008
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00693849

United States, California
Shanti Clinical Trials Completed
Colton, California, United States, 92324
A.D.D. Treatment Center Completed
Mission Viejo, California, United States, 92691
Stanford University Completed
Stanford, California, United States, 94305
Veteran Affairs/Stanford University Completed
Stanford, California, United States, 94305
Center for Healing the Human Spirit Completed
Tarzana, California, United States, 91356
United States, Florida
University of Miami Completed
Miami, Florida, United States, 33136
United States, Missouri
University of Missouri - St. Louis Completed
St. Louis, Missouri, United States, 63121
United States, New Jersey
Brain Resource Center Completed
Englewood Cliffs, New Jersey, United States, 07632
United States, New York
Brain Resource Center Completed
New York, New York, United States, 10023
Weill Cornell Medical College Completed
White Plains, New York, United States, 10605
United States, North Carolina
Skyland Behavioral Health Associates , P.A. Completed
Ashville, North Carolina, United States, 28801
United States, Ohio
Ohio State University Completed
Columbus, Ohio, United States, 43210
United States, Rhode Island
NeuroDevelopment Center Completed
Providence, Rhode Island, United States, 02903
Australia, New South Wales
Brain Dynamics Centre Active, not recruiting
Westmead, New South Wales, Australia, 2145
Australia, South Australia
Flinders University Completed
Adelaide, South Australia, Australia, 5042
Australia, Victoria
Delmont Private Hospital Withdrawn
Glen Iris, Victoria, Australia, 3146
Swinburne University Completed
Melbourne, Victoria, Australia, 3122
The Alfred Hospital Completed
Melbourne, Victoria, Australia, 3181
Brainclinics Diagnostics B.V. Recruiting
Nijmegen, Gelderland, Netherlands, 6524 AD
Contact: Tabitha Iseger       Tabitha@brainclinics.com   
Principal Investigator: Martijn Arns, PhD         
New Zealand
University of Auckland Completed
Auckland, New Zealand, 1142
South Africa
Brain Health Lab Completed
Johannesburg, Guatang, South Africa, 2191
Sponsors and Collaborators
BRC Operations Pty. Ltd.
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
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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: BRC Operations Pty. Ltd.
ClinicalTrials.gov Identifier: NCT00693849     History of Changes
Other Study ID Numbers: iSPOT-D
First Posted: June 9, 2008    Key Record Dates
Last Update Posted: January 23, 2017
Last Verified: May 2016

Keywords provided by BRC Operations Pty. Ltd.:

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Venlafaxine Hydrochloride
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Serotonin and Noradrenaline Reuptake Inhibitors