Major Depressive Disorder Clinical Trial
Official title:
A Randomized Study of a Comprehensive Yoga Intervention for Patients With Major Depressive Disorder With Incomplete Response to Antidepressants
Verified date | December 2015 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
The purpose of this study is to evaluate the efficacy of a multi-component yoga intervention featuring Sudarshan Kriya Yoga (SKY) as an adjunctive treatment for patients with Major Depressive Disorders with incomplete response to antidepressants.
Status | Completed |
Enrollment | 25 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 67 Years |
Eligibility |
Inclusion Criteria: - DSM-IV Major Depressive Disorder - Able to give informed consent - Aged 18-67 - Currently in outpatient care for MDD - On a stable antidepressant regimen for at least 2 months - 17-item Hamilton Depression Score >14 at screening & baseline visit Exclusion Criteria: - Currently in crisis requiring inpatient treatment - Bipolar Disorder, Psychotic Disorder, ADHD, Substance Use Disorder - Pregnancy, Epilepsy - Initiating psychotherapy or other yoga/meditation program |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Mood & Anxiety Disorders Research and Treatment Program | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Serum Inflammatory Markers | Baseline, 1 month, 2 month | No | |
Primary | 17-item Hamilton Depression Rating Scale | Baseline to 2 month | No | |
Secondary | Beck Depression Inventory | Baseline to 2 month | No | |
Secondary | Beck Anxiety Inventory | Baseline to 2 month | No | |
Secondary | Columbia Suicide Severity Rating Scale | Baseline, 1 month, 2 month | Yes |
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