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Measuring Response to Depression Treatment

Measuring Response to Depression Treatment: A Study Comparing the Sensitivity of Multiple Outcome Measures to Change

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00924183
Enrollment
70
Registered
2009-06-18
Start date
2008-06-30
Completion date
2011-07-31
Last updated
2011-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

OTHERTreatment-as-usual

Sponsors

AstraZeneca
CollaboratorINDUSTRY
Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc.
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Quality of Life Enjoyment Satisfaction Questionnaire (Q-LES-Q)Day 0, Week 8
Hamilton Rating Scale for Depression (HAM-D)Pre-Baseline, Day 0, Week 1, Week 4, Week 8
Vancouver Semi-Structured Interview for Depression (V-SID)Pre-Baseline, Day 0, Week 1, Week 4, Week 8
Montgomery-Asberg Depression Rating Scale (MADRS)Pre-Baseline, Day 0, Week 1, Week 4, Week 8
Clinical Global ImpressionPre-Baseline, Day 0, Week 1, Week 4, Week 8, Followup
Hamilton Rating Scale for Anxiety (HAM-A)Pre-Baseline, Day 0, Week 1, Week 4, Week 8
British Columbia Major Depression Inventory (BC-MDI)Pre-Baseline, Day 0, Week 1, Week 4, Week 8

Secondary

MeasureTime frame
British Columbia Cognitive Complaints Inventory (BC-CCI)Pre-Baseline, Day 0, Week 1, Week 4, Week 8
Grip strengthPre-Baseline, Day 0, Week 8
Cortisol levelDay 0, Week 8
Neuroimmunobiologic markersPre-Baseline, Week 8
Evaluation for Metabolic SyndromeDay 0, Week 8, Followup
CNS Vital SignsPre-Baseline, Day 0, Week 8

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026