Measuring Response to Depression Treatment

Study Overview
=================
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.

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

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Other: Treatment-as-usual


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treatment-as-usual<br>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<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
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