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
  Purpose

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 Intervention Phase
Major Depressive Disorder
Drug: Escitalopram
Drug: Sertraline
Drug: Venlafaxine XR
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: International Study to Predict Optimised Treatment - in Depression

Resource links provided by NLM:


Further study details as provided by BRC Operations Pty. Ltd.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 2688
Study Start Date: September 2008
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Escitalopram
Drug: Escitalopram
10 mg/day as a single dose, increased to max 20 mg/day
Other Name: Lexapro
Active Comparator: B
Sertraline
Drug: Sertraline
50 mg/day as a single dose, increased to max of 200 mg/day
Other Name: Zoloft
Active Comparator: C
Venlafaxine
Drug: Venlafaxine XR
75 mg/day given once daily; increased to 150-225 mg/day
Other Name: Effexor
No Intervention: D
Healthy matched controls

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00693849

Locations
United States, California
Shanti Clinical Trials Active, not recruiting
Colton, California, United States, 92324
A.D.D. Treatment Center Active, not recruiting
Mission Viejo, California, United States, 92691
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Maureen Chang    650-725-4620    mhchang@stanford.edu   
Principal Investigator: Charles Debattista, MD         
Veteran Affairs/Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Jurema Gobena       jagobena@stanford.edu   
Principal Investigator: Amit Etkin         
Sub-Investigator: Alan Schatzberg         
Center for Healing the Human Spirit Active, not recruiting
Tarzana, California, United States, 91356
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Tania Guardia    305-243-5563    tguardia@med.miami.edu   
Principal Investigator: Radu V Saveanu, MD         
Principal Investigator: Patricia Junquera, MD         
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 Recruiting
White Plains, New York, United States, 10605
Contact: XiaoLei Baran       xyu@med.cornell.edu   
Principal Investigator: XiaoLei Yu Baran, MD         
United States, North Carolina
Skyland Behavioral Health Associates , P.A. Completed
Ashville, North Carolina, United States, 28801
United States, Ohio
Ohio State University Active, not recruiting
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 Active, not recruiting
Glen Iris, Victoria, Australia, 3146
Swinburne University Active, not recruiting
Melbourne, Victoria, Australia, 3122
The Alfred Hospital Active, not recruiting
Melbourne, Victoria, Australia, 3181
Netherlands
Brainclinics Diagnostics B.V. Active, not recruiting
Nijmegen, Gelderland, Netherlands, 6524 AD
New Zealand
University of Auckland Active, not recruiting
Auckland, New Zealand, 1142
South Africa
Brain Health Lab Completed
Johannesburg, Guatang, South Africa, 2191
Sponsors and Collaborators
BRC Operations Pty. Ltd.
Investigators
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
  More Information

Additional Information:
No publications provided by BRC Operations Pty. Ltd.

Additional 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
Study First Received: June 6, 2008
Last Updated: June 7, 2013
Health Authority: United States: Institutional Review Board
Australia: National Health and Medical Research Council
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
South Africa: Human Research Ethics Committee

Keywords provided by BRC Operations Pty. Ltd.:
depression
CNS
iSPOT
MDD

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Dexetimide
Citalopram
Sertraline
Venlafaxine
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 31, 2014