Clinical trial NCT02998762: Long-Term Follow Up Study
Official title: CAN-BIND (Canadian Biomarker Integration Network for Depression): Long-Term Follow Up Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Major Depressive Disorder
Keywords: major depression
major depressive disorder
biomarkers
MDD
long term follow up
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Queen's University
name: McMaster University
name: University of Calgary
name: University of British Columbia
First posted: 2016-12-20
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Montgomery-Asberg Depression Rating Scale (MADRS) (Montgomery and Asberg 1979) scores from CAN-BIND baseline
timeFrame: Every six months up to Year 5
Secondary outcomes:
measure: Longitudinal Interval Follow-up Evaluation (LIFE) (Keller et al., 1978)
timeFrame: Every six months up to Year 5
measure: Life Events and Difficulties Schedule (LEDS) (Brown & Harris, 1978)
timeFrame: Every six months up to Year 5
Other outcomes:
measure: Quick Inventory Depressive Symptomatology-Self Report (QIDS-SR) (Rush et al., 2003)
timeFrame: Every six months up to Year 5
measure: Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Endicott et al., 1993)
timeFrame: Every six months up to Year 5
measure: Sheehan Disability Scale - Visual Analog Scale (SDS-VAS) (Sheehan et al., 1996)
timeFrame: Every six months up to Year 5
measure: The Dimensional Anhedonia Rating Scale (DARS) (Rizvi et al., 2015)
timeFrame: Every six months up to Year 5
measure: World Health Organization Quality of Life Short Version (WHOQOL-BREF) (Orley & Kuyken, 1994)
timeFrame: Every six months up to Year 5
measure: Brief Symptom Inventory (BSI-53) (Derogatis et al., 1993)
timeFrame: Every six months up to Year 5
measure: Generalized Anxiety Disorder 7-item (GAD-7) (Spitzer et al., 2006)
timeFrame: Every six months up to Year 5
measure: Pittsburgh Sleep Quality Index (PSQI) (Buysse at al., 1989)
timeFrame: Every six months up to Year 5
measure: Copenhagen Burnout Inventory (CBI) (Kristensen et al., 2005)
timeFrame: Every six months up to Year 5
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
city: Kingston
country: Canada
facility: Queen's University
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Sidney H. Kennedy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Health Network, Toronto
name: Shane McInerney, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.