Measuring Response to Depression Treatment

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00924183
• Other study ID #: D1443L00014
• Status: Active, not recruiting
• Phase: N/A
• First received: June 10, 2009
• Last updated: March 22, 2011
• Start date: June 2008
• Est. completion date: July 2011

Study information

• Verified date: March 2011
• Source: Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 65 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Other:
• Treatment-as-usual

Locations

Country	Name	City	State
Canada	Copeman Neuroscience Centre	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc.	AstraZeneca

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Rating Scale for Depression (HAM-D)		Pre-Baseline, Day 0, Week 1, Week 4, Week 8	No
Primary	Vancouver Semi-Structured Interview for Depression (V-SID)		Pre-Baseline, Day 0, Week 1, Week 4, Week 8	No
Primary	Montgomery-Asberg Depression Rating Scale (MADRS)		Pre-Baseline, Day 0, Week 1, Week 4, Week 8	No
Primary	Clinical Global Impression		Pre-Baseline, Day 0, Week 1, Week 4, Week 8, Followup	No
Primary	Hamilton Rating Scale for Anxiety (HAM-A)		Pre-Baseline, Day 0, Week 1, Week 4, Week 8	No
Primary	British Columbia Major Depression Inventory (BC-MDI)		Pre-Baseline, Day 0, Week 1, Week 4, Week 8	No
Primary	Quality of Life Enjoyment Satisfaction Questionnaire (Q-LES-Q)		Day 0, Week 8	No
Secondary	CNS Vital Signs		Pre-Baseline, Day 0, Week 8	No
Secondary	British Columbia Cognitive Complaints Inventory (BC-CCI)		Pre-Baseline, Day 0, Week 1, Week 4, Week 8	No
Secondary	Grip strength		Pre-Baseline, Day 0, Week 8	No
Secondary	Cortisol level		Day 0, Week 8	No
Secondary	Neuroimmunobiologic markers		Pre-Baseline, Week 8	No
Secondary	Evaluation for Metabolic Syndrome		Day 0, Week 8, Followup	Yes