Measuring Response to Depression Treatment

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc.
ClinicalTrials.gov Identifier:
NCT00924183
First received: June 10, 2009
Last updated: March 22, 2011
Last verified: March 2011
  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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]
  • Vancouver Semi-Structured Interview for Depression (V-SID) [ Time Frame: Pre-Baseline, Day 0, Week 1, Week 4, Week 8 ] [ Designated as safety issue: No ]
  • Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Pre-Baseline, Day 0, Week 1, Week 4, Week 8 ] [ Designated as safety issue: No ]
  • Clinical Global Impression [ Time Frame: Pre-Baseline, Day 0, Week 1, Week 4, Week 8, Followup ] [ Designated as safety issue: No ]
  • Hamilton Rating Scale for Anxiety (HAM-A) [ Time Frame: Pre-Baseline, Day 0, Week 1, Week 4, Week 8 ] [ Designated as safety issue: No ]
  • British Columbia Major Depression Inventory (BC-MDI) [ Time Frame: Pre-Baseline, Day 0, Week 1, Week 4, Week 8 ] [ Designated as safety issue: No ]
  • Quality of Life Enjoyment Satisfaction Questionnaire (Q-LES-Q) [ Time Frame: Day 0, Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CNS Vital Signs [ Time Frame: Pre-Baseline, Day 0, Week 8 ] [ Designated as safety issue: No ]
  • British Columbia Cognitive Complaints Inventory (BC-CCI) [ Time Frame: Pre-Baseline, Day 0, Week 1, Week 4, Week 8 ] [ Designated as safety issue: No ]
  • Grip strength [ Time Frame: Pre-Baseline, Day 0, Week 8 ] [ Designated as safety issue: No ]
  • Cortisol level [ Time Frame: Day 0, Week 8 ] [ Designated as safety issue: No ]
  • Neuroimmunobiologic markers [ Time Frame: Pre-Baseline, Week 8 ] [ Designated as safety issue: No ]
  • Evaluation for Metabolic Syndrome [ Time Frame: Day 0, Week 8, Followup ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: June 10, 2009
Last Updated: March 22, 2011
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on July 22, 2014