Canadian Biomarker Integration Network for Depression Study (CAN-BIND-1)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01655706 |
|
Recruitment Status :
Completed
First Posted : August 2, 2012
Last Update Posted : May 11, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Major Depressive Disorder | Drug: escitalopram Drug: aripiprazole | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 211 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Factorial Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| Official Title: | Integrated Biological Markers for the Prediction of Treatment Response in Depression |
| Actual Study Start Date : | April 23, 2012 |
| Actual Primary Completion Date : | January 2017 |
| Actual Study Completion Date : | January 2017 |
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: escitalopram (10-20mg)
Patients are on escitalopram for 8 weeks. At Week 8, patients will be assessed as 'responders' or 'non-responders'. 'Responders' will continue on escitalopram until study endpoint.
|
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.
Other Name: Cipralex |
|
Active Comparator: aripiprazole (2-10mg)
At Week 8, patients assessed as 'non-responders' will be given aripiprazole as an add-on treatment to escitalopram.
|
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.
Other Name: Cipralex Drug: aripiprazole At Week 8, patients assessed as 'non-responders' will be given aripiprazole as an add-on treatment to escitalopram.
Other Name: Abilify |
- Change in MADRS (Montgomery-Asberg Depression Rating Scale) scores from baseline [ Time Frame: Week 8, Week 16 ]Clinical response (≥ 50% reduction in MADRS scores from baseline)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01655706
| Canada, Alberta | |
| University of Calgary | |
| Calgary, Alberta, Canada, T2N 2T9 | |
| Canada, British Columbia | |
| University of British Columbia | |
| Vancouver, British Columbia, Canada, V6T 2A1 | |
| Canada, Ontario | |
| McMaster University | |
| Hamilton, Ontario, Canada, L8P 3B6 | |
| Queen's University | |
| Kingston, Ontario, Canada, K7L 4X3 | |
| University Health Network | |
| Toronto, Ontario, Canada, M5G 2C4 | |
| Centre for Addiction and Mental Health | |
| Toronto, Ontario, Canada, M5T 1R8 | |
| Principal Investigator: | Sidney Kennedy, MD | University Health Network, University of Toronto |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Sidney Kennedy, Psychiatrist, Pricipal Investigator, University Health Network, Toronto |
| ClinicalTrials.gov Identifier: | NCT01655706 |
| Other Study ID Numbers: |
11-0917-A |
| First Posted: | August 2, 2012 Key Record Dates |
| Last Update Posted: | May 11, 2018 |
| Last Verified: | May 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | This study is funded by the Ontario Brain Institute (OBI). Data collected from this study is entered into a research database called "Brain-CODE", deployed at a High Performance Computer Virtual Lab (HPCVL). The HPCVL supports the regulatory-compliant (e.g. 21 CRF Part 11, HIPPA, PIPEDA) processes for securing privacy of healthcare data. |
|
major depression major depressive disorder biomarkers escitalopram aripiprazole |
MDD neuroimaging proteomic genomics |
|
Depression Depressive Disorder Depressive Disorder, Major Behavioral Symptoms Mood Disorders Mental Disorders Aripiprazole Citalopram Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents Physiological Effects of Drugs |
Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Dopamine Agonists Dopamine Agents Serotonin 5-HT1 Receptor Agonists Serotonin Receptor Agonists Serotonin 5-HT2 Receptor Antagonists Serotonin Antagonists Dopamine D2 Receptor Antagonists Dopamine Antagonists |