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| Sponsor: | Centre for Addiction and Mental Health |
|---|---|
| Information provided by: | Centre for Addiction and Mental Health |
| ClinicalTrials.gov Identifier: | NCT00482482 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Bipolar Disorder Major Depression Dysthymic Disorder |
Behavioral: psychoeducation Behavioral: Yoga |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Safety and Effectiveness of Yoga as Augmentation in Improving Residual Depressive Symptoms in Unipolar and Bipolar Disorders. |
| Enrollment: | 90 |
| Study Start Date: | September 2007 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Behavioral: Yoga
on weekly basis for 8 weeks
|
| Active Comparator: 2 |
Behavioral: psychoeducation
on weekly basis for 8 weeks
|
Major depression (particularly recurrent and chronic depression) and bipolar depression remain complex and vexing problems for the clinician. They can be difficult to treat with pharmacotherapy alone and the persistence of residual symptoms (with consequent impact on function) and sub-syndromal symptoms increase the risk of relapse. Psychotherapy and alternative therapies have been explored as adjunctive treatments to pharmacotherapy and have shown efficacy in symptom relief. Complementary therapies, like herbal remedies and yoga, have also shown efficacy, but primarily in unipolar depression.
Yoga is a widely accepted practice that is very accessible and adaptable to different age ranges and levels of physical ability. Yoga, has been shown to be effective in the treatment of major depression and dysthymia in randomized, controlled trials. To date,Yoga has not been investigated in subjects with bipolar disorder.
We would like to replicate current investigative results on yoga and depression in a Canadian sample with unipolar and chronic depression, and would like to extend the literature by investigating its efficacy in bipolar disorder. Could adjunctive Yoga treat sub-syndromal depressive symptoms and thus reduce the risk of relapse in patients with unipolar and bipolar depression? With high consumer desirability, there is general agreement on the need for well-designed, randomized controlled trials examining the efficacy and safety of these interventions in clinical populations.
This is a prospective, assessor-blind, crossover, randomized controlled study, and will be carried out in three phases: 1) 16-week treatment phase, 2) 1 year follow-up phase. Forty patients meeting DSM-IV-TR diagnostic criteria for either Major Depression, Dysthymia, Bipolar I or Bipolar II will be recruited. Patients who have provided written consent, have met study criteria, and are stabilized on pharmacotherapy (i.e. receiving either one or two mood stabilizer(s) alone, or in combination with an oral atypical antipsychotic or an antidepressant or lamotrigine) will be enrolled into the study.
All patients will receive treatment with Yoga and psychoeducation in addition to their standard pharmacotherapy and will be randomized to one of two treatment groups groups 1) 8 weeks of yoga followed by 8 weeks of psychoeducation; or 2) 8 weeks of psychoeducation followed by 8 weeks of Yoga. After completion of the treatment phase, there will be a 12-month follow-up phase.
The specific hypotheses are:
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Canada, Ontario | |
| Centre for Addition and Mental Health | |
| Toronto, Ontario, Canada, M5T 1R8 | |
| Principal Investigator: | Arun Ravindran, MD, PhD | Centre for Addiction and Mental Health |
More Information
| Responsible Party: | Dr. Arun Ravindran, Centre for Addiction and Mental Health |
| ClinicalTrials.gov Identifier: | NCT00482482 History of Changes |
| Other Study ID Numbers: | 308/2006 |
| Study First Received: | June 1, 2007 |
| Last Updated: | March 31, 2011 |
| Health Authority: | Canada: Health Canada |
|
Yoga Bipolar disorder Major depression Dysthymia Randomized |
|
Bipolar Disorder Depression Depressive Disorder Dysthymic Disorder Depressive Disorder, Major |
Affective Disorders, Psychotic Mood Disorders Mental Disorders Behavioral Symptoms |