Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
100 participants
OBSERVATIONAL
2016-05-31
2019-02-25
Brief Summary
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Detailed Description
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The study is conducted in partnership with Janssen Research \& Development and utilizes remote monitoring technology for data gathering.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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MDD
Major Depressive Disorder
Observational
Interventions
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Observational
Eligibility Criteria
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Inclusion Criteria
* MADRS total score of equal to or less than 14.
* In the current MDE, patient must currently be responding to an antidepressant medication or a combination of treatments for MDD.
* Willing and able to complete self-reported assessments via a study-specific smartphone (LogPad), including sufficient fluency in English.
* Willing to wear GT9X Link, a wrist-worn device for the duration of the study.
Exclusion Criteria
* Bipolar I or Bipolar II diagnosis (lifetime), MDD with psychotic features (lifetime), schizophrenia, or schizoaffective disorder.
* Presence of a significant Axis II diagnosis (borderline, antisocial).
* High suicidal risk, defined by clinician judgement.
* History of drug or alcohol use, with severity of at least moderate or severe, according to DSM criteria, within 6 months before screening.
* Presence of significant neurological disorders, head trauma, or other unstable medical conditions.
* Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 90 days before screening or is currently enrolled in an investigational study.
* Has a condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (e.g. compromise well being) or that could prevent, limit, or confound the protocol-specified assessments.
* Subject is an employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, or is a family member of an employee or the investigator.
18 Years
65 Years
ALL
No
Sponsors
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Sidney Kennedy
OTHER
Responsible Party
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Sidney Kennedy
Senior Scientist, Psychiatrist
Principal Investigators
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Sidney H. Kennedy, MD
Role: PRINCIPAL_INVESTIGATOR
University Health Network, Toronto
Locations
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University of Calgary
Calgary, Alberta, Canada
University of British Columbia
Vancouver, British Columbia, Canada
McMaster University
Hamilton, Ontario, Canada
Queen's University
Kingston, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
Countries
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References
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Kennedy SH, Downar J, Evans KR, Feilotter H, Lam RW, MacQueen GM, Milev R, Parikh SV, Rotzinger S, Soares C. The Canadian Biomarker Integration Network in Depression (CAN-BIND): advances in response prediction. Curr Pharm Des. 2012;18(36):5976-89. doi: 10.2174/138161212803523635.
Lam RW, Milev R, Rotzinger S, Andreazza AC, Blier P, Brenner C, Daskalakis ZJ, Dharsee M, Downar J, Evans KR, Farzan F, Foster JA, Frey BN, Geraci J, Giacobbe P, Feilotter HE, Hall GB, Harkness KL, Hassel S, Ismail Z, Leri F, Liotti M, MacQueen GM, McAndrews MP, Minuzzi L, Muller DJ, Parikh SV, Placenza FM, Quilty LC, Ravindran AV, Salomons TV, Soares CN, Strother SC, Turecki G, Vaccarino AL, Vila-Rodriguez F, Kennedy SH; CAN-BIND Investigator Team. Discovering biomarkers for antidepressant response: protocol from the Canadian biomarker integration network in depression (CAN-BIND) and clinical characteristics of the first patient cohort. BMC Psychiatry. 2016 Apr 16;16:105. doi: 10.1186/s12888-016-0785-x.
Vaccarino AL, Evans KR, Kalali AH, Kennedy SH, Engelhardt N, Frey BN, Greist JH, Kobak KA, Lam RW, MacQueen G, Milev R, Placenza FM, Ravindran AV, Sheehan DV, Sills T, Williams JB. The Depression Inventory Development Workgroup: A Collaborative, Empirically Driven Initiative to Develop a New Assessment Tool for Major Depressive Disorder. Innov Clin Neurosci. 2016 Oct 1;13(9-10):20-31. eCollection 2016 Sep-Oct.
Related Links
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Other Identifiers
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REB 15-9780-AE
Identifier Type: -
Identifier Source: org_study_id