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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02934334 |
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Date of registration:
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12/10/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Wellness Monitoring for Major Depressive Disorder
CBN-Well |
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Scientific title:
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A Collaborative Investigation of Predictors of Relapse in Major Depressive Disorder: CAN-BIND-1 Extension Study |
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Date of first enrolment:
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May 31, 2016 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02934334 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Canada
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Contacts
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Name:
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Sidney H. Kennedy, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Health Network, Toronto |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Meet DSM-V criteria for Major Depressive Episode (MDE) in MDD as determined by MINI.
- MADRS total score of equal to or less than 14.
- In the current MDE, patient must currently be responding to an antidepressant
medication or a combination of treatments for MDD.
- Willing and able to complete self-reported assessments via a study-specific smartphone
(LogPad), including sufficient fluency in English.
- Willing to wear GT9X Link, a wrist-worn device for the duration of the study.
Exclusion Criteria:
- 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 severity of at least moderate or severe,
according to DSM criteria, within 6 months before screening.
- Presence of significant neurological disorders, head trauma, or other unstable medical
conditions.
- Received an investigational drug (including investigational vaccines) or used an
invasive investigational medical device within 90 days before screening or is
currently enrolled in an investigational study.
- Has a condition for which, in the opinion of the investigator, participation would not
be in the best interest of the subject (e.g. compromise well being) or that could
prevent, limit, or confound the protocol-specified assessments.
- Subject is an employee of the investigator or study site, with direct involvement in
the proposed study or other studies under the direction of that investigator or study
site, or is a family member of an employee or the investigator.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Major Depressive Disorder
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Intervention(s)
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Other: Observational
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Primary Outcome(s)
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Rate of MDD Patients with Near Term Relapse
[Time Frame: Baseline up to the one year enrolment period for the last-subject-in.]
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Secondary ID(s)
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REB 15-9780-AE
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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