Long-Term Follow Up Study

Major Depressive Disorder Clinical Trial

— CAN-BIND LTFU  

Official title:

CAN-BIND (Canadian Biomarker Integration Network for Depression): Long-Term Follow Up Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02998762
• Other study ID #: 15-9055-AE
• Status: Completed
• Start date: February 3, 2016
• Est. completion date: July 29, 2019

Study information

• Verified date: November 2020
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: July 29, 2019
• Est. primary completion date: July 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	McMaster University	Hamilton	Ontario
Canada	Queen's University	Kingston	Ontario
Canada	University Health Network	Toronto	Ontario
Canada	University of British Columbia	Vancouver	British Columbia

Sponsors (5)

Lead Sponsor	Collaborator
Sidney Kennedy	McMaster University, Queen's University, University of British Columbia, University of Calgary

Country where clinical trial is conducted

Canada, 

References & 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. — View 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, Müller 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quick Inventory Depressive Symptomatology-Self Report (QIDS-SR) (Rush et al., 2003)	The QIDS-SR is a 16 item scale used to assess the severity of depressive illness derived from the 30-item Inventory of Depressive Symptomatology (IDS). The scale includes questions on mood, sleep and level of interest, and takes 5-10 minutes to complete.	Every six months up to Year 5
Other	Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Endicott et al., 1993)	This 16-item questionnaire contains questions about your general life satisfaction on aspects such as physical health, leisure time and overall sense of well-being. Each item is scored on a 5-point scale (very poor to very good); higher scores indicate greater satisfaction and enjoyment. It takes 5 minutes to complete.	Every six months up to Year 5
Other	Sheehan Disability Scale - Visual Analog Scale (SDS-VAS) (Sheehan et al., 1996)	The SDS-VAS is a self-rated questionnaire that assesses functional disability and impairment due to psychiatric symptoms. The SDS-VAS consists of three functional impairment items and two items related to productivity losses due to the symptoms and impairment. Impairment is evaluated with the 10-point self-rated social life and family life/home responsibilities subscales of the Sheehan Disability Scale (0, none; 1-3, mild; 4-6, moderate; 7-9, marked; 10, extreme). Significant impairment for each subscale was defined by a rating of 7 or higher.	Every six months up to Year 5
Other	The Dimensional Anhedonia Rating Scale (DARS) (Rizvi et al., 2015)	The DARS is a new measure of anhedonia developed to address the limitations of the existing scales. It extends the concept of anhedonia to assess desire, motivation, effort and consummatory pleasure across four domains: pastimes/hobbies, food/drink, social activities and sensory experiences. Individuals are asked to list their own examples within each domain and respond to standardized questions on a Likert scale according to how they are feeling "right now".	Every six months up to Year 5
Other	World Health Organization Quality of Life Short Version (WHOQOL-BREF) (Orley & Kuyken, 1994)	The WHOQOL-BREF is a 26-item self-rated questionnaire that assesses perceived quality of life across four domains. The domains of health assessed include physical health, psychological health, social relationships and environment. Domain scores and global scores can be generated. The questions are related to aspects of the patient's life in the last four weeks.	Every six months up to Year 5
Other	Brief Symptom Inventory (BSI-53) (Derogatis et al., 1993)	The BSI-53 is a 53-item self-rated questionnaire that assesses depression across nine symptom dimensions. The nine dimensions are somatization, obsession-compulsion, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation and psychoticism. The number and intensity of symptomatology is given by three indices, the Global Severity Index, Positive Symptom Distress Index and Positive Symptom Total (PST). Each item is ranked on a 5-point scale from 0 (not at all) to 4 (extremely), and rankings represent intensity of distress over the past week.	Every six months up to Year 5
Other	Generalized Anxiety Disorder 7-item (GAD-7) (Spitzer et al., 2006)	The GAD-7 is a 7-item self-rated questionnaire with good reliability and validity for assessing generalized anxiety disorder and its severity over the past two weeks. Items are ranked on a 4-point scale from 0 (not at all sure) to 3 (nearly every day), providing a total severity score from 0 to 21.	Every six months up to Year 5
Other	Pittsburgh Sleep Quality Index (PSQI) (Buysse at al., 1989)	The PSQI is a self-rated questionnaire specifically designed to measure sleep quality. The questionnaire includes questions on sleep duration, sleep disturbance, sleep latency, day dysfunction due to sleepiness, sleep efficiency, overall sleep quality and need for medication to sleep. This questionnaire takes less than 5 minutes to complete.	Every six months up to Year 5
Other	Copenhagen Burnout Inventory (CBI) (Kristensen et al., 2005)	The CBI consists of three scales measuring personal burnout, work-related burnout, and client-related burnout, for use in different domains. Each subscale on the CBI is scored from a range of 0 to 100. Respondents who gained an average score of 50 or higher on each of the scales are deemed to have a positive response to the screen and to warrant further investigation by a mental health professional.	Every six months up to Year 5
Primary	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	Longitudinal Interval Follow-up Evaluation (LIFE) (Keller et al., 1978)	The LIFE is a clinician-rated interview that provides a structure for collecting and coding data on the longitudinal course of psychopathology. It allows for precise dating of onset and offset of symptoms (including sub-syndromal symptoms) and ranks severity on a week by week basis.	Every six months up to Year 5
Secondary	Life Events and Difficulties Schedule (LEDS) (Brown & Harris, 1978)	The LEDS is a semi-structured interview that collects detailed contextual information regarding acute stressful life events and chronic difficulties in several domains.	Every six months up to Year 5

External Links

•   CAN-BIND Study Website