Measuring Response to Depression Treatment

Sponsor

Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc. (Other)

Overall Status

Unknown status

CT.gov ID

NCT00924183

Collaborator

AstraZeneca (Industry)

Enrollment

Location

Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depression	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 Design

Study Type:

Observational

Anticipated Enrollment :

70 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jun 1, 2008

Anticipated Primary Completion Date :

Jul 1, 2011

Anticipated Study Completion Date :

Jul 1, 2011

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)