Overview

This trial is active, not recruiting.

Condition depression
Treatment treatment-as-usual
Sponsor Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc.
Collaborator AstraZeneca
Start date June 2008
End date July 2011
Trial size 70 participants
Trial identifier NCT00924183, D1443L00014

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
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.
treatment-as-usual

Primary Outcomes

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

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 19 years up to 65 years old.

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)

Additional Information

Official title Measuring Response to Depression Treatment: A Study Comparing the Sensitivity of Multiple Outcome Measures to Change
Principal investigator Diane McIntosh, MD, FRCPC
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2011.
Information provided to ClinicalTrials.gov by Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc..