Measuring Response to Depression Treatment

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

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.

Study Overview

• Status: Unknown
• Conditions: Depression
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 70

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 2L4
      • Copeman Neuroscience Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Impression	Pre-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
Quality of Life Enjoyment Satisfaction Questionnaire (Q-LES-Q)	Day 0, Week 8

Secondary Outcome Measures

Outcome Measure	Time Frame
CNS Vital Signs	Pre-Baseline, Day 0, Week 8
British Columbia Cognitive Complaints Inventory (BC-CCI)	Pre-Baseline, Day 0, Week 1, Week 4, Week 8
Grip strength	Pre-Baseline, Day 0, Week 8
Cortisol level	Day 0, Week 8
Neuroimmunobiologic markers	Pre-Baseline, Week 8
Evaluation for Metabolic Syndrome	Day 0, Week 8, Followup

Collaborators and Investigators

• Sponsor: Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc.
• Collaborators: AstraZeneca
• Investigators: Principal Investigator: Diane McIntosh, MD, FRCPC, Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc.

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Anticipated): July 1, 2011
• Study Completion (Anticipated): July 1, 2011

Study Registration Dates

• First Submitted: June 10, 2009
• First Submitted That Met QC Criteria: June 16, 2009
• First Posted (Estimate): June 18, 2009

Study Record Updates

• Last Update Posted (Estimate): March 23, 2011
• Last Update Submitted That Met QC Criteria: March 22, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: Depression; open-label; open label; treatment as usual; Major Depressive Episode; MDE; Symptom scales; Symptom measures; Vancouver Semi-Structured Interview for Depression; V-SID; VSID; treatment-as-usual
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: D1443L00014