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Long-Term Follow Up Study

NCT ID: NCT02998762

Last Updated: 2020-11-03

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

96 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-03

Study Completion Date

2019-07-29

Brief Summary

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The LTFU study will conduct a naturalistic follow up of the well characterized CAN-BIND study population of patients every six months and continuing over a five-year period. This will provide information on the longitudinal progress in mood, functioning, and quality of life of the CAN-BIND sample with a view towards long-term outcome and treatment.

Detailed Description

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This is a long-term follow up study of the 'Canadian Biomarker Integration Network in Depression' (CAN-BIND) study. The CAN-BIND study examines biological markers of antidepressant treatment response. The examined biomarkers included clinical, imaging, and genetic components. The Long Term Follow up (LTFU) study will continue to follow the patients in this study each six months over a five year period. By doing so, a comprehensive clinical outcome data on a well characterized cohort of depressed patients will be obtained.

The research team will conduct a naturalistic study of CAN-BIND participants and will monitor the longitudinal progress in mood, functioning, and quality of life, with a view towards advising future treatment options. Each patient completing CAN-BIND will be asked to participate in the LTFU study.

Conditions

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Major Depressive Disorder

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Each patient completing the 16 weeks of CAN-BIND who have previously met DSM-IV-TR criteria for Major Depressive Episode (MDE) in MDD as determined by MINI.

Exclusion Criteria

* Any Axis I diagnosis, other than MDD, that is considered the primary diagnosis.
* 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 a severity of at least moderate or severe, according to DSM criteria, within the previous 6 months.
* Presence of significant neurologic disorder, head trauma, or other unstable medical conditions.
* Subject has any condition, for which in the opinion of the investigator, participation would not be in the interest of the subject (e.g. compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Queen's University

OTHER

Sponsor Role collaborator

McMaster University

OTHER

Sponsor Role collaborator

University of Calgary

OTHER

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role collaborator

Sidney Kennedy

OTHER

Sponsor Role lead

Responsible Party

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Sidney Kennedy

Senior Scientist, Psychiatrist

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Sidney H. Kennedy, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Shane McInerney, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

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University of Calgary

Calgary, Alberta, Canada

Site Status

University of British Columbia

Vancouver, British Columbia, Canada

Site Status

McMaster University

Hamilton, Ontario, Canada

Site Status

Queen's University

Kingston, Ontario, Canada

Site Status

University Health Network

Toronto, Ontario, Canada

Site Status

Countries

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Canada

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.

Reference Type BACKGROUND
PMID: 22681173 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27974997 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27084692 (View on PubMed)

Related Links

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http://www.canbind.ca

CAN-BIND Study Website

Other Identifiers

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15-9055-AE

Identifier Type: -

Identifier Source: org_study_id