Long-Term Follow Up Study

NCT02998762 | Completed DMC

• 1 other identifier: 15-9055-AE
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Major Depressive Disorder

Keywords

major depression; major depressive disorder; biomarkers; MDD; long term follow up

Outcome Measures

Primary Outcomes (1)

• Change in Montgomery-Asberg Depression Rating Scale (MADRS) (Montgomery and Asberg 1979) scores from CAN-BIND baseline

  Clinical response (equal to or greater than 50% reduction in MADRS scores from CAN-BIND baseline); Relapse is determined if the MADRS score is greater than or equal to 22 or there is suicidal ideation with intent, or suicidal behaviour.

  Every six months up to Year 5

Secondary Outcomes (2)

• Longitudinal Interval Follow-up Evaluation (LIFE) (Keller et al., 1978)

  Every six months up to Year 5

• Life Events and Difficulties Schedule (LEDS) (Brown & Harris, 1978)

  Every six months up to Year 5

Other Outcomes (9)

• Quick Inventory Depressive Symptomatology-Self Report (QIDS-SR) (Rush et al., 2003)

  Every six months up to Year 5

• Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Endicott et al., 1993)

  Every six months up to Year 5

• Sheehan Disability Scale - Visual Analog Scale (SDS-VAS) (Sheehan et al., 1996)

  Every six months up to Year 5

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sidney Kennedy: lead
• Queen's University: collaborator
• McMaster University: collaborator
• University of Calgary: collaborator
• University of British Columbia: collaborator

Study Sites (5)

University of Calgary

Calgary, Alberta, T2N 2T9, Canada

Location

University of British Columbia

Vancouver, British Columbia, V6T 2A1, Canada

Location

McMaster University

Hamilton, Ontario, L8N 3K7, Canada

Location

Queen's University

Kingston, Ontario, K7L 4X3, Canada

Location

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (3)

• 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.

  PMID: 22681173 BACKGROUND

• 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.

  PMID: 27974997 BACKGROUND

• 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.

  PMID: 27084692 BACKGROUND

Related Links

• CAN-BIND Study Website

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Sidney H. Kennedy, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

• Shane McInerney, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Scientist, Psychiatrist

Study Record Dates

• First Submitted: December 16, 2016
• First Posted: December 20, 2016
• Study Start: February 3, 2016
• Primary Completion: July 29, 2019
• Study Completion: July 29, 2019
• Last Updated: November 3, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share

Locations

CA (5)