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Measuring Response to Depression Treatment

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2011 by Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc..
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00924183
First Posted: June 18, 2009
Last Update Posted: March 23, 2011
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.
Collaborator:
AstraZeneca
Information provided by:
Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc.
  Purpose
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 Intervention
Depression Other: Treatment-as-usual

Study Type: Observational
Study Design: 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

Further study details as provided by Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc.:

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

Secondary Outcome Measures:
  • CNS Vital Signs [ Time Frame: Pre-Baseline, Day 0, Week 8 ]
  • British Columbia Cognitive Complaints Inventory (BC-CCI) [ Time Frame: Pre-Baseline, Day 0, Week 1, Week 4, Week 8 ]
  • Grip strength [ Time Frame: Pre-Baseline, Day 0, Week 8 ]
  • Cortisol level [ Time Frame: Day 0, Week 8 ]
  • Neuroimmunobiologic markers [ Time Frame: Pre-Baseline, Week 8 ]
  • 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.

Estimated Enrollment: 70
Study Start Date: June 2008
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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:   19 Years to 65 Years   (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
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
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
Principal Investigator: Diane McIntosh, MD, FRCPC Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc.
  More Information

Responsible Party: Dr. Diane McIntosh, Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc.
ClinicalTrials.gov Identifier: NCT00924183     History of Changes
Other Study ID Numbers: D1443L00014
First Submitted: June 10, 2009
First Posted: June 18, 2009
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:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders