Measuring Response to Depression Treatment
March 22, 2011 updated by: Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc.
Measuring Response to Depression Treatment: A Study Comparing the Sensitivity of Multiple Outcome Measures to Change
The primary goal of this study is to compare a new symptoms rating questionnaire, called the Vancouver Semi-Structured Interview for Depression (V-SID), to the traditionally used questionnaires.
The investigators predict that the V-SID will be more sensitive to patients' improvement than are traditional questionnaires.
Study Overview
Detailed Description
Depression is sometimes associated with difficulties in thinking skills. Recent evidence suggests that in those people who have thinking difficulties, effective treatment and improvement of depression can also result in improved thinking skills. Therefore, a test of thinking skills is included in this study.
This study will also evaluate three other potential indicators of treatment response: cortisol, cytokines, and grip strength.
Study Type
Observational
Enrollment (Anticipated)
70
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada, V6Z 2L4
- Copeman Neuroscience Centre
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All subjects will diagnosed with a current major depressive episode.
They will be recruited from a community healthcare centre.
Description
Inclusion Criteria:
- Major depressive episode, diagnosed using the Mini-International Neuropsychiatric Interview (MINI)
- Depression not currently effectively treated
- Age 19 to 65 years
Exclusion Criteria:
- Co-morbid Axis I disorders (co-morbid anxiety symptoms, including generalized anxiety or panic attacks, are not exclusionary if they are present in the context of a primary mood disorder)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Treatment-as-usual
All patients will receive treatment as usual: antidepressant medication and/or cognitive behavioral therapy (CBT).
Patients' results will be compare to their own baseline measurements.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Hamilton Rating Scale for Depression (HAM-D)
Time Frame: Pre-Baseline, Day 0, Week 1, Week 4, Week 8
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Pre-Baseline, Day 0, Week 1, Week 4, Week 8
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Vancouver Semi-Structured Interview for Depression (V-SID)
Time Frame: Pre-Baseline, Day 0, Week 1, Week 4, Week 8
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Pre-Baseline, Day 0, Week 1, Week 4, Week 8
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Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame: Pre-Baseline, Day 0, Week 1, Week 4, Week 8
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Pre-Baseline, Day 0, Week 1, Week 4, Week 8
|
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Clinical Global Impression
Time Frame: Pre-Baseline, Day 0, Week 1, Week 4, Week 8, Followup
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Pre-Baseline, Day 0, Week 1, Week 4, Week 8, Followup
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Hamilton Rating Scale for Anxiety (HAM-A)
Time Frame: Pre-Baseline, Day 0, Week 1, Week 4, Week 8
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Pre-Baseline, Day 0, Week 1, Week 4, Week 8
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British Columbia Major Depression Inventory (BC-MDI)
Time Frame: Pre-Baseline, Day 0, Week 1, Week 4, Week 8
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Pre-Baseline, Day 0, Week 1, Week 4, Week 8
|
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Quality of Life Enjoyment Satisfaction Questionnaire (Q-LES-Q)
Time Frame: Day 0, Week 8
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Day 0, Week 8
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
CNS Vital Signs
Time Frame: Pre-Baseline, Day 0, Week 8
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Pre-Baseline, Day 0, Week 8
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British Columbia Cognitive Complaints Inventory (BC-CCI)
Time Frame: Pre-Baseline, Day 0, Week 1, Week 4, Week 8
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Pre-Baseline, Day 0, Week 1, Week 4, Week 8
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Grip strength
Time Frame: Pre-Baseline, Day 0, Week 8
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Pre-Baseline, Day 0, Week 8
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Cortisol level
Time Frame: Day 0, Week 8
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Day 0, Week 8
|
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Neuroimmunobiologic markers
Time Frame: Pre-Baseline, Week 8
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Pre-Baseline, Week 8
|
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Evaluation for Metabolic Syndrome
Time Frame: Day 0, Week 8, Followup
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Day 0, Week 8, Followup
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Diane McIntosh, MD, FRCPC, Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (Anticipated)
July 1, 2011
Study Completion (Anticipated)
July 1, 2011
Study Registration Dates
First Submitted
June 10, 2009
First Submitted That Met QC Criteria
June 16, 2009
First Posted (Estimate)
June 18, 2009
Study Record Updates
Last Update Posted (Estimate)
March 23, 2011
Last Update Submitted That Met QC Criteria
March 22, 2011
Last Verified
March 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D1443L00014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.