Yoga in Unipolar and Bipolar Disorders
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|ClinicalTrials.gov Identifier: NCT00482482|
Recruitment Status : Completed
First Posted : June 5, 2007
Last Update Posted : December 5, 2012
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 or disease||Intervention/treatment||Phase|
|Bipolar Disorder Major Depression Dysthymia||Behavioral: psychoeducation Behavioral: Yoga||Not Applicable|
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:
- At week 8 (the end of the first part of the treatment phase), those who are treated with Yoga plus pharmacotherapy would show a decrease in residual depressive symptoms indicated by greater reduction in MADRS scores relative to baseline and an increase in quality of life measures, as compared to those treated with psychoeducation plus pharmacotherapy.
- At week 16 (the end of the second part of the treatment phase), those who are treated with yoga plus pharmacotherapy would show a decrease in residual depressive symptoms indicated by greater reduction in MADRS scores relative to baseline and an increase in quality of life measures, as compared to those treated with psychoeducation plus pharmacotherapy..
- Improvement in depressive symptoms will correlate with neuroendocrine changes in salivary cortisol.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||The Safety and Effectiveness of Yoga as Augmentation in Improving Residual Depressive Symptoms in Unipolar and Bipolar Disorders.|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||March 2011|
Yoga was offered twice a week for 8 weeks, 1.5 hours per session
on weekly basis for 8 weeks
Active Comparator: Psychoeducation
Psychoeducation was offered twice a week for 8 weeks, 1.5 hours per session
on weekly basis for 8 weeks
- Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Start of study, 8 weeks and 16 weeks ]
- Salivary cortisol levels [ Time Frame: Start of study, 8 weeks, 16 weeks ]
- Clinical Global Impression Scale [ Time Frame: Start of study, 8 weeks and 16 weeks ]
- Quality of Life Enjoyment and Satisfaction Scale [ Time Frame: Start of study, 8 weeks and 16 weeks ]
- Perceived Stress Scale [ Time Frame: Start of study, 8 weeks and 16 weeks ]
- Coping Strategies Scale [ Time Frame: Start of study, 8 weeks and 16 weeks ]
- Beck Depression Inventory [ Time Frame: Start of study, 8 weeks and 16 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00482482
|Centre for Addition and Mental Health|
|Toronto, Ontario, Canada, M5T 1R8|
|Principal Investigator:||Arun Ravindran, MD, PhD||Centre for Addiction and Mental Health|