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Measuring Response to Depression Treatment

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ClinicalTrials.gov Identifier: NCT00924183
Recruitment Status : Unknown
Verified March 2011 by Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc..
Recruitment status was:  Active, not recruiting
First Posted : June 18, 2009
Last Update Posted : March 23, 2011
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Depression Other: Treatment-as-usual

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 Design
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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Measuring Response to Depression Treatment: A Study Comparing the Sensitivity of Multiple Outcome Measures to Change
Study Start Date : June 2008
Estimated Primary Completion Date : July 2011
Estimated Study Completion Date : July 2011

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 Other: Treatment-as-usual


Outcome Measures
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Primary Outcome Measures :
  1. Hamilton Rating Scale for Depression (HAM-D) [ Time Frame: Pre-Baseline, Day 0, Week 1, Week 4, Week 8 ]
  2. Vancouver Semi-Structured Interview for Depression (V-SID) [ Time Frame: Pre-Baseline, Day 0, Week 1, Week 4, Week 8 ]
  3. Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Pre-Baseline, Day 0, Week 1, Week 4, Week 8 ]
  4. Clinical Global Impression [ Time Frame: Pre-Baseline, Day 0, Week 1, Week 4, Week 8, Followup ]
  5. Hamilton Rating Scale for Anxiety (HAM-A) [ Time Frame: Pre-Baseline, Day 0, Week 1, Week 4, Week 8 ]
  6. British Columbia Major Depression Inventory (BC-MDI) [ Time Frame: Pre-Baseline, Day 0, Week 1, Week 4, Week 8 ]
  7. Quality of Life Enjoyment Satisfaction Questionnaire (Q-LES-Q) [ Time Frame: Day 0, Week 8 ]

Secondary Outcome Measures :
  1. CNS Vital Signs [ Time Frame: Pre-Baseline, Day 0, Week 8 ]
  2. British Columbia Cognitive Complaints Inventory (BC-CCI) [ Time Frame: Pre-Baseline, Day 0, Week 1, Week 4, Week 8 ]
  3. Grip strength [ Time Frame: Pre-Baseline, Day 0, Week 8 ]
  4. Cortisol level [ Time Frame: Day 0, Week 8 ]
  5. Neuroimmunobiologic markers [ Time Frame: Pre-Baseline, Week 8 ]
  6. Evaluation for Metabolic Syndrome [ Time Frame: Day 0, Week 8, Followup ]

Biospecimen Retention:   Samples With DNA
Plasma and white blood cells will be isolated from whole blood samples and will be stored for future analysis.

Eligibility Criteria
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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

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): NCT00924183


Locations
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Canada, British Columbia
Copeman Neuroscience Centre
Vancouver, British Columbia, Canada, V6Z 2L4
Sponsors and Collaborators
Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc.
AstraZeneca
Investigators
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Principal Investigator: Diane McIntosh, MD, FRCPC Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc.
More Information
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Responsible Party: Dr. Diane McIntosh, Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc.
ClinicalTrials.gov Identifier: NCT00924183    
Other Study ID Numbers: D1443L00014
First Posted: June 18, 2009    Key Record Dates
Last Update Posted: March 23, 2011
Last Verified: March 2011
Keywords provided by Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc.:
Depression
Symptom scales
Symptom measures
Vancouver Semi-Structured Interview for Depression
V-SID
VSID
 treatment-as-usual
treatment as usual
open-label
open label
Major Depressive Episode
MDE
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders