Back to resultsInternational Study to Predict Optimised Treatment - in Depression (iSPOT-D)
Primary Purpose
Major Depressive Disorder
Status
Unknown status
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Escitalopram
Sertraline
Venlafaxine-XR
Sponsored by
About this trial
This is an interventional health services research trial for Major Depressive Disorder focused on measuring depression, CNS, iSPOT, MDD
Eligibility 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.
Sites / Locations
- Shanti Clinical Trials
- A.D.D. Treatment Center
- Stanford University
- Veteran Affairs/Stanford University
- Center for Healing the Human Spirit
- University of Miami
- University of Missouri - St. Louis
- Brain Resource Center
- Brain Resource Center
- Weill Cornell Medical College
- Skyland Behavioral Health Associates , P.A.
- Ohio State University
- NeuroDevelopment Center
- Brain Dynamics Centre
- Flinders University
- Swinburne University
- The Alfred Hospital
- Brainclinics Diagnostics B.V.
- University of Auckland
- Brain Health Lab
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
No Intervention
Arm Label
A
B
C
D
Arm Description
Escitalopram
Sertraline
Venlafaxine-XR
Healthy matched controls
Outcomes
Primary Outcome Measures
To determine whether the genetic-brain-cognition function markers (or combination of markers) 'normalise' with acute drug treatment in MDD
Secondary Outcome Measures
To determine whether markers of acute treatment prediction are also predictive of functional outcome over 6-12 months.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00693849
Brief Title
International Study to Predict Optimised Treatment - in Depression
Acronym
iSPOT-D
Official Title
International Study to Predict Optimised Treatment - in Depression
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2008 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BRC Operations Pty. Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
depression, CNS, iSPOT, MDD
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2688 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
Escitalopram
Arm Title
B
Arm Type
Active Comparator
Arm Description
Sertraline
Arm Title
C
Arm Type
Active Comparator
Arm Description
Venlafaxine-XR
Arm Title
D
Arm Type
No Intervention
Arm Description
Healthy matched controls
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Other Intervention Name(s)
Lexapro
Intervention Description
10 mg/day as a single dose, increased to max 20 mg/day
Intervention Type
Drug
Intervention Name(s)
Sertraline
Other Intervention Name(s)
Zoloft
Intervention Description
50 mg/day as a single dose, increased to max of 200 mg/day
Intervention Type
Drug
Intervention Name(s)
Venlafaxine-XR
Other Intervention Name(s)
Effexor
Intervention Description
75 mg/day given once daily; increased to 150-225 mg/day
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To determine whether markers of acute treatment prediction are also predictive of functional outcome over 6-12 months.
Time Frame
52-weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Harris, MD
Organizational Affiliation
Brain Dynamics Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Barbara A. Cohen, PhD
Organizational Affiliation
Center for Healing the Human Spirit
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bruce Russell, PhD
Organizational Affiliation
University of Auckland, New Zealand
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Charles Debattista, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Con Stough, PhD
Organizational Affiliation
Swinburne University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elizabeth Wallis, PhD
Organizational Affiliation
Brain Health Lab
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Harbans Multani, MD
Organizational Affiliation
Shanti Clinical Trials
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jayashri Kulkarni, Prof
Organizational Affiliation
The Alfred and Delmont Private Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeffrey Wilson, PhD
Organizational Affiliation
A.D.D. Treatment Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kamran Fallahpour, PhD
Organizational Affiliation
Brain Resource Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Larry Hirshberg, PhD
Organizational Affiliation
NeuroDevelopment Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martijn Arns, PhD
Organizational Affiliation
Brainclinics Diagnostics B.V.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mona Ismail, MD
Organizational Affiliation
Brain Resource Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paul Fitzgerald, PhD
Organizational Affiliation
The Alfred
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard Clark, PhD
Organizational Affiliation
Flinders University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Roger deBeus, PhD
Organizational Affiliation
Skyland Behavioral Health Associates
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Steven Bruce, PhD
Organizational Affiliation
University of Missouri, St. Louis
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Subhdeep Virk, MD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tim Usherwood, MD
Organizational Affiliation
Brain Dynamics Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
XiaoLei Yu Baran, MD
Organizational Affiliation
Cornell University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Radu V Saveanu, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanti Clinical Trials
City
Colton
State/Province
California
ZIP/Postal Code
92324
Country
United States
Facility Name
A.D.D. Treatment Center
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Veteran Affairs/Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Center for Healing the Human Spirit
City
Tarzana
State/Province
California
ZIP/Postal Code
91356
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of Missouri - St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63121
Country
United States
Facility Name
Brain Resource Center
City
Englewood Cliffs
State/Province
New Jersey
ZIP/Postal Code
07632
Country
United States
Facility Name
Brain Resource Center
City
New York
State/Province
New York
ZIP/Postal Code
10023
Country
United States
Facility Name
Weill Cornell Medical College
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States
Facility Name
Skyland Behavioral Health Associates , P.A.
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
NeuroDevelopment Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Brain Dynamics Centre
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Flinders University
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Swinburne University
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3122
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3181
Country
Australia
Facility Name
Brainclinics Diagnostics B.V.
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6524 AD
Country
Netherlands
Facility Name
University of Auckland
City
Auckland
ZIP/Postal Code
1142
Country
New Zealand
Facility Name
Brain Health Lab
City
Johannesburg
State/Province
Guatang
ZIP/Postal Code
2191
Country
South Africa
12. IPD Sharing Statement
Citations:
PubMed Identifier
34349116
Citation
Braund TA, Tillman G, Palmer DM, Gordon E, Rush AJ, Harris AWF. Antidepressant side effects and their impact on treatment outcome in people with major depressive disorder: an iSPOT-D report. Transl Psychiatry. 2021 Aug 4;11(1):417. doi: 10.1038/s41398-021-01533-1.
Results Reference
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Citation
Krepel N, Benschop L, Baeken C, Sack AT, Arns M. An EEG signature of suicidal behavior in female patients with major depressive disorder? A non-replication. Biol Psychol. 2021 Apr;161:108058. doi: 10.1016/j.biopsycho.2021.108058. Epub 2021 Feb 26.
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PubMed Identifier
33230268
Citation
Fischer AS, Holt-Gosselin B, Fleming SL, Hack LM, Ball TM, Schatzberg AF, Williams LM. Intrinsic reward circuit connectivity profiles underlying symptom and quality of life outcomes following antidepressant medication: a report from the iSPOT-D trial. Neuropsychopharmacology. 2021 Mar;46(4):809-819. doi: 10.1038/s41386-020-00905-3. Epub 2020 Nov 23.
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PubMed Identifier
32568399
Citation
Rajpurkar P, Yang J, Dass N, Vale V, Keller AS, Irvin J, Taylor Z, Basu S, Ng A, Williams LM. Evaluation of a Machine Learning Model Based on Pretreatment Symptoms and Electroencephalographic Features to Predict Outcomes of Antidepressant Treatment in Adults With Depression: A Prespecified Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2020 Jun 1;3(6):e206653. doi: 10.1001/jamanetworkopen.2020.6653. Erratum In: JAMA Netw Open. 2020 Jul 1;3(7):e2016001.
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PubMed Identifier
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Citation
Korgaonkar MS, Goldstein-Piekarski AN, Fornito A, Williams LM. Intrinsic connectomes are a predictive biomarker of remission in major depressive disorder. Mol Psychiatry. 2020 Jul;25(7):1537-1549. doi: 10.1038/s41380-019-0574-2. Epub 2019 Nov 6.
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PubMed Identifier
31601424
Citation
Tozzi L, Goldstein-Piekarski AN, Korgaonkar MS, Williams LM. Connectivity of the Cognitive Control Network During Response Inhibition as a Predictive and Response Biomarker in Major Depression: Evidence From a Randomized Clinical Trial. Biol Psychiatry. 2020 Mar 1;87(5):462-472. doi: 10.1016/j.biopsych.2019.08.005. Epub 2019 Aug 21.
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PubMed Identifier
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Citation
Braund TA, Tillman G, Palmer DM, Harris AWF. Verbal memory predicts treatment outcome in syndromal anxious depression: An iSPOT-D report. J Affect Disord. 2020 Jan 1;260:245-253. doi: 10.1016/j.jad.2019.09.028. Epub 2019 Sep 4.
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Citation
Keller AS, Ball TM, Williams LM. Deep phenotyping of attention impairments and the 'Inattention Biotype' in Major Depressive Disorder. Psychol Med. 2020 Oct;50(13):2203-2212. doi: 10.1017/S0033291719002290. Epub 2019 Sep 3.
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PubMed Identifier
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Citation
Hellewell SC, Welton T, Maller JJ, Lyon M, Korgaonkar MS, Koslow SH, Williams LM, Rush AJ, Gordon E, Grieve SM. Profound and reproducible patterns of reduced regional gray matter characterize major depressive disorder. Transl Psychiatry. 2019 Jul 24;9(1):176. doi: 10.1038/s41398-019-0512-8.
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Braund TA, Palmer DM, Williams LM, Harris AWF. Dimensions of anxiety in Major depressive disorder and their use in predicting antidepressant treatment outcome: an iSPOT-D report. Psychol Med. 2020 Apr;50(6):1032-1042. doi: 10.1017/S0033291719000941. Epub 2019 Apr 26.
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PubMed Identifier
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Citation
Graziano RC, Bruce SE, Paul RH, Korgaonkar MS, Williams LM. The effects of bullying in depression on white matter integrity. Behav Brain Res. 2019 May 2;363:149-154. doi: 10.1016/j.bbr.2019.01.054. Epub 2019 Jan 30.
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PubMed Identifier
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Citation
Kircanski K, Williams LM, Gotlib IH. Heart rate variability as a biomarker of anxious depression response to antidepressant medication. Depress Anxiety. 2019 Jan;36(1):63-71. doi: 10.1002/da.22843. Epub 2018 Oct 12.
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PubMed Identifier
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Maller JJ, Broadhouse K, Rush AJ, Gordon E, Koslow S, Grieve SM. Increased hippocampal tail volume predicts depression status and remission to anti-depressant medications in major depression. Mol Psychiatry. 2018 Aug;23(8):1737-1744. doi: 10.1038/mp.2017.224. Epub 2017 Nov 14.
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PubMed Identifier
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Iseger TA, Korgaonkar MS, Kenemans JL, Grieve SM, Baeken C, Fitzgerald PB, Arns M. EEG connectivity between the subgenual anterior cingulate and prefrontal cortices in response to antidepressant medication. Eur Neuropsychopharmacol. 2017 Apr;27(4):301-312. doi: 10.1016/j.euroneuro.2017.02.002. Epub 2017 Feb 23.
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Goldstein-Piekarski AN, Korgaonkar MS, Green E, Suppes T, Schatzberg AF, Hastie T, Nemeroff CB, Williams LM. Human amygdala engagement moderated by early life stress exposure is a biobehavioral target for predicting recovery on antidepressants. Proc Natl Acad Sci U S A. 2016 Oct 18;113(42):11955-11960. doi: 10.1073/pnas.1606671113. Epub 2016 Oct 10.
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PubMed Identifier
27137427
Citation
Grieve SM, Korgaonkar MS, Gordon E, Williams LM, Rush AJ. Prediction of nonremission to antidepressant therapy using diffusion tensor imaging. J Clin Psychiatry. 2016 Apr;77(4):e436-43. doi: 10.4088/JCP.14m09577.
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PubMed Identifier
26995298
Citation
Shilyansky C, Williams LM, Gyurak A, Harris A, Usherwood T, Etkin A. Effect of antidepressant treatment on cognitive impairments associated with depression: a randomised longitudinal study. Lancet Psychiatry. 2016 May;3(5):425-35. doi: 10.1016/S2215-0366(16)00012-2. Epub 2016 Mar 16.
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PubMed Identifier
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Citation
van Dinteren R, Arns M, Kenemans L, Jongsma ML, Kessels RP, Fitzgerald P, Fallahpour K, Debattista C, Gordon E, Williams LM. Utility of event-related potentials in predicting antidepressant treatment response: An iSPOT-D report. Eur Neuropsychopharmacol. 2015 Nov;25(11):1981-90. doi: 10.1016/j.euroneuro.2015.07.022. Epub 2015 Aug 6.
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PubMed Identifier
26137532
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Korgaonkar MS, Rekshan W, Gordon E, Rush AJ, Williams LM, Blasey C, Grieve SM. Magnetic Resonance Imaging Measures of Brain Structure to Predict Antidepressant Treatment Outcome in Major Depressive Disorder. EBioMedicine. 2014 Dec 3;2(1):37-45. doi: 10.1016/j.ebiom.2014.12.002. eCollection 2015 Jan.
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PubMed Identifier
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Schatzberg AF, DeBattista C, Lazzeroni LC, Etkin A, Murphy GM Jr, Williams LM. ABCB1 Genetic Effects on Antidepressant Outcomes: A Report From the iSPOT-D Trial. Am J Psychiatry. 2015 Aug 1;172(8):751-9. doi: 10.1176/appi.ajp.2015.14050680. Epub 2015 Mar 27.
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Results Reference
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Links:
URL
http://www.ANZCTR.org.au/ACTRN12608000476336.aspx
Description
Australian New Zealand Clinical Trials Registry
Learn more about this trial
International Study to Predict Optimised Treatment - in Depression
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