Clinical trial NCT00924183: Measuring Response to Depression Treatment
Official title: Measuring Response to Depression Treatment: A Study Comparing the Sensitivity of Multiple Outcome Measures to Change
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Depression
Keywords: 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
Lead sponsor: Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc.
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2009-06-18
Enrollment: 70
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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 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)

Primary outcomes:
measure: Hamilton Rating Scale for Depression (HAM-D)
timeFrame: Pre-Baseline, Day 0, Week 1, Week 4, Week 8
measure: Vancouver Semi-Structured Interview for Depression (V-SID)
timeFrame: Pre-Baseline, Day 0, Week 1, Week 4, Week 8
measure: Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: Pre-Baseline, Day 0, Week 1, Week 4, Week 8
measure: Clinical Global Impression
timeFrame: Pre-Baseline, Day 0, Week 1, Week 4, Week 8, Followup
measure: Hamilton Rating Scale for Anxiety (HAM-A)
timeFrame: Pre-Baseline, Day 0, Week 1, Week 4, Week 8
measure: British Columbia Major Depression Inventory (BC-MDI)
timeFrame: Pre-Baseline, Day 0, Week 1, Week 4, Week 8
measure: Quality of Life Enjoyment Satisfaction Questionnaire (Q-LES-Q)
timeFrame: Day 0, Week 8
Secondary outcomes:
measure: CNS Vital Signs
timeFrame: Pre-Baseline, Day 0, Week 8
measure: British Columbia Cognitive Complaints Inventory (BC-CCI)
timeFrame: Pre-Baseline, Day 0, Week 1, Week 4, Week 8
measure: Grip strength
timeFrame: Pre-Baseline, Day 0, Week 8
measure: Cortisol level
timeFrame: Day 0, Week 8
measure: Neuroimmunobiologic markers
timeFrame: Pre-Baseline, Week 8
measure: Evaluation for Metabolic Syndrome
timeFrame: Day 0, Week 8, Followup
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Copeman Neuroscience Centre
state: British Columbia
Study officials:
affiliation: Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc.
name: Diane McIntosh, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: