Major Depressive Disorder Clinical Trial
Official title:
Mindfulness-Based Cognitive Therapy Depression Efficacy and Effects on Inflammatory Biomarker Levels
NCT number | NCT02385786 |
Other study ID # | 11-07162 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2011 |
Est. completion date | August 2012 |
Verified date | March 2022 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will investigate the efficacy of an 8-week course in Mindfulness-Based Cognitive Therapy (MBCT) for adults with major depressive disorder (MDD) by ;measuring change from baseline to completion of treatment at 8 weeks in terms of depression severity using the Hamilton Depression Ratings Scale. We will measure change in C-Reactive Protein, a measure of inflammation, over the same time period.
Status | Completed |
Enrollment | 43 |
Est. completion date | August 2012 |
Est. primary completion date | August 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - English speaking - Able to give informed consent - DSM-IV (SCID) Diagnosis of Major Depression - HAM-D17 score = 17 - Good general medical health; no active significant uncontrolled medical illness - Free of antidepressant medication for a minimum of 6 weeks before study entry - Not "needle phobic" by self report Exclusion Criteria: - Axis I and II disorders including: Bipolar, Obsessive Compulsive Disorder, Psychosis, or Antisocial or Borderline Personality Disorder with suicidal risk - Major Depression with Psychotic Features - Actively suicidal - Recent (6 month) history of substance or alcohol dependence (DSM-IV criteria) - Meditation practice once or more per week - Yoga practice more than twice per week at study entry - Mini Mental Status Exam score < 25or history of neurologic illness |
Country | Name | City | State |
---|---|---|---|
United States | University of California, San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hamilton Depression Rating Scale Change with MBCT treatment | 17-item clinician-rated measure of depression severity. | Week 0, 8 | |
Secondary | C-Reactive Protein (Blood) Change with MBCT treatment | An inflammatory biomarker that varies with levels of inflammation in the body | Week 0-8 |
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