Trial record 1 of 1 for:
iSPOT-D
International Study to Predict Optimised Treatment - in Depression (iSPOT-D)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00693849 |
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Recruitment Status : Unknown
Verified July 2018 by BRC Operations Pty. Ltd..
Recruitment status was: Active, not recruiting
First Posted : June 9, 2008
Last Update Posted : July 11, 2018
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Sponsor:
BRC Operations Pty. Ltd.
Information provided by (Responsible Party):
BRC Operations Pty. Ltd.
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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 |
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 2019 |
| Estimated Study Completion Date : | December 2019 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Depression
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: A
Escitalopram
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Drug: Escitalopram
10 mg/day as a single dose, increased to max 20 mg/day
Other Name: Lexapro |
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Active Comparator: B
Sertraline
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Drug: Sertraline
50 mg/day as a single dose, increased to max of 200 mg/day
Other Name: Zoloft |
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Active Comparator: C
Venlafaxine-XR
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Drug: Venlafaxine-XR
75 mg/day given once daily; increased to 150-225 mg/day
Other Name: Effexor |
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No Intervention: D
Healthy matched controls
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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 ]
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 ]
Information from the National Library of Medicine
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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.
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
Locations
Show 20 study locations
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 | |
| 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):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | BRC Operations Pty. Ltd. |
| ClinicalTrials.gov Identifier: | NCT00693849 |
| Other Study ID Numbers: |
iSPOT-D |
| First Posted: | June 9, 2008 Key Record Dates |
| Last Update Posted: | July 11, 2018 |
| Last Verified: | July 2018 |
Keywords provided by BRC Operations Pty. Ltd.:
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depression CNS iSPOT MDD |
Additional relevant MeSH terms:
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Depression Depressive Disorder Depressive Disorder, Major Behavioral Symptoms Mood Disorders Mental Disorders Venlafaxine Hydrochloride Sertraline Escitalopram Selective Serotonin Reuptake 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 Serotonin and Noradrenaline Reuptake Inhibitors |