Bipolar Disorder Clinical Trial
Official title:
The Safety and Effectiveness of Yoga as Augmentation in Improving Residual Depressive Symptoms in Unipolar and Bipolar Disorders.
Verified date | December 2012 |
Source | Centre for Addiction and Mental Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
Major depression, chronic depression and bipolar depression are complex and difficult
disorders to treat. They are often associated with residual symptoms with significant
functional impairment. Yoga has been shown to be beneficial in treating depressive symptoms
but without the added risks associated with medication use and has the advantage of high
consumer appeal (with likelihood of good compliance). However, it has only been tested in
unipolar depression, thus far. Yoga if shown to be effective (as an adjunctive to
pharmacotherapy) in improving residual symptoms and decreasing risk of relapse, would be of
significant long-term benefit to patients not only with major and chronic depression, but
also for those with bipolar disorder.
The aim of the study is to determine the safety and effectiveness of Yoga as an augmentation
treatment to pharmacotherapy and in comparison to psychoeducation, in improving residual
symptoms of depression over 16 weeks and in prevention of relapse/recurrence of mood
episodes over 1 year, in subjects with unipolar and bipolar disorders.
Status | Completed |
Enrollment | 90 |
Est. completion date | March 2011 |
Est. primary completion date | March 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Male or female patients meeting DSM-IV-TR diagnostic criteria for either Major Depression, Dysthymia, Bipolar I or Bipolar II disorder - MADRS score of =10 and =24 and a YMRS score of =8 - Age 18 to 75 years - Free of significant physical illness as evidenced by medical history, physical exam, routine clinical investigations and as clinically judged to be able to tolerate physical activities - Participants taking prophylactic pharmacotherapy for unipolar or bipolar disorders at a stable dose for a minimum of two weeks prior to enrollment Exclusion Criteria: - Participants currently in a Manic, Hypomanic, or Mixed Phase - Participants meeting DSM-IV-TR diagnostic criteria for Rapid Cycling specifier - History of psychosis not due to Major Depression or Bipolar Disorder, e.g. schizophrenia, schizoaffective disorder, etc. - Alcohol or Substance Abuse or Dependence within past 3 months - Participants currently receiving any systematic structured psychotherapy. Supportive therapy is allowed. - Those with major medical illness, or physical impairment that impact ones ability to participate in the study as evidenced by medical history, physical exam, and clinical investigations |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Centre for Addition and Mental Health | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Centre for Addiction and Mental Health |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Montgomery-Asberg Depression Rating Scale (MADRS) | Start of study, 8 weeks and 16 weeks | No | |
Secondary | Salivary cortisol levels | Start of study, 8 weeks, 16 weeks | No | |
Secondary | Clinical Global Impression Scale | Start of study, 8 weeks and 16 weeks | No | |
Secondary | Quality of Life Enjoyment and Satisfaction Scale | Start of study, 8 weeks and 16 weeks | No | |
Secondary | Perceived Stress Scale | Start of study, 8 weeks and 16 weeks | No | |
Secondary | Coping Strategies Scale | Start of study, 8 weeks and 16 weeks | No | |
Secondary | Beck Depression Inventory | Start of study, 8 weeks and 16 weeks | No |
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