Canadian Biomarker Integration Network for Depression Study

Major Depressive Disorder Clinical Trial

— CAN-BIND-1  

Official title:

Integrated Biological Markers for the Prediction of Treatment Response in Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01655706
• Other study ID #: 11-0917-A
• Status: Completed
• Phase: Phase 3
• Start date: April 23, 2012
• Est. completion date: January 2017

Study information

• Verified date: May 2018
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a pilot to assess feasibility of the protocol in patients and controls across six participating sites. The goal is to identify biological markers (biomarkers)that can be measured at baseline or early in treatment to predict treatment outcome in individual patients with Major Depressive Disorder (MDD). Biomarkers of interest will be clinical (using interview and self-report measures), molecular (from blood samples) and neurobiological (using neuroimaging and EEG).

Description:

This is a study to collect clinical and biomarker data which will be used to build models to predict treatment response. This is not a study to evaluate efficacy of medications, as medications in this study have been approved by Health Canada and are widely used for the treatment of MDD.

This is an open label study involving MDD patients and healthy controls.Patients with a diagnosis of MDD and a current major depressive episode (MDE) will receive open-label standard of care treatment with escitalopram (10-20mg). Healthy controls will not receive medication; however, they will go through clinical assessments, blood collection and neuroimaging procedures.

At week 8, patients will be assessed for medication response (response is defined as ≥ 50% reduction in MADRS scores from baseline). Responders will continue medication at their effective dose until study endpoint while non-responders will receive open label add-on treatment with aripiprazole (2-10mg).

There are approximately 7 clinic visits over a 16 week period during which patients and healthy controls will undergo clinician administered scales and self reports, provide blood and urine samples (which will undergo proteomic and genomic analyses) as well as neuroimaging (fMRI and EEG).

At the end of the study, mathematical modeling methods will be used to integrate the data from the various modalities to see which features best predict treatment outcome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

For Depressed patients:

Inclusion Criteria:

• Outpatients who are 18-60 years of age

• Meet DSM-IV-TR criteria for Major Depressive Episode in Major Depressive Disorder by the MINI

• Episode duration = 3 months

• Free of psychotropic medications for at least 5 half-lives (i.e. 1 week for most antidepressants, 5 weeks for fluoxetine) before baseline Visit 1

• MADRS = 24

• Fluency in English, sufficient to complete the interviews and self-report questionnaires

Exclusion Criteria:

• Any Axis I diagnosis other than MDD that is considered the primary diagnosis

• Bipolar I or Bipolar II diagnosis

• Presence of a significant Axis II diagnosis (borderline, antisocial)

• High suicidal risk, defined by clinician judgment

• Substance dependence/abuse in the past 6 months

• Presence of significant neurological disorders, head trauma or other unstable medical conditions

• Pregnant or breastfeeding

• Failure of 3 or more adequate pharmacologic interventions (as determined by the Antidepressant Treatment History Form)

• Started psychological treatment within the past 3 months with the intent of continuing treatment

• Patients who have previously failed escitalopram or showed intolerance to escitalopram and patients at risk for hypomanic switch (i.e. with a history of antidepressant hypomania)

Inclusion criteria for Healthy Controls:

• 18 to 60 years of age

• No history of Axis I or Axis II disorders, as determined by the MINI.

• Fluency in English, sufficient to complete the interviews and self-report questionnaires.

Related Conditions & MeSH terms

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

Intervention

Drug:
• escitalopram
Patients will be given escitalopram for the first 8 weeks of the trial. At week 8, patients who are assessed as 'responders' will continue on escitalopram until study endpoint.
• aripiprazole
At Week 8, patients assessed as 'non-responders' will be given aripiprazole as an add-on treatment to escitalopram.

Locations

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

Sponsors (8)

Lead Sponsor	Collaborator
University Health Network, Toronto	Centre for Addiction and Mental Health, McGill University, McMaster University, Queen's University, University of British Columbia, University of Calgary, University of Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in MADRS (Montgomery-Asberg Depression Rating Scale) scores from baseline	Clinical response (= 50% reduction in MADRS scores from baseline)	Week 8, Week 16

External Links

•   "Treating Depression Takes Too Long"
•   A news article from the Calgary site promoting the CAN-BIND project.
•   CAN-BIND study website