Measuring Response to Depression Treatment

• Conditions: Depression
• Interventions: Other: Treatment-as-usual

• Registration Number: NCT00924183
• Lead Sponsor: Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc.

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.

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2009-06-10
• Study First Submitted QC: 2009-06-16
• Study First Posted: 2009-06-18
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-22
• Last Update Posted: 2011-03-23
• Primary Completion: 2011-07
• Study Completion: 2011-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment-as-usual	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.

Primary Outcome Measures

Name	Time	Method
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
Vancouver Semi-Structured Interview for Depression (V-SID)	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 Depression (HAM-D)	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Copeman Neuroscience Centre; 🇨🇦 Vancouver, British Columbia, Canada