Yoga in Unipolar and Bipolar Disorders
Condition: Bipolar Disorder; Major Depression; Dysthymia
MeSH terms: Depression; Bipolar Disorder; Depressive Disorder, Major; Dysthymic Disorder
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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:

        1. 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.

        2. 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..

        3. Improvement in depressive symptoms will correlate with neuroendocrine changes in
           salivary cortisol.
    

Intervention name(s): psychoeducation; Yoga
Intervention type(s): Behavioral; Behavioral
Intervention description(s): on weekly basis for 8 weeks; on weekly basis for 8 weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Yoga; Bipolar disorder; Major depression; Dysthymia; Randomized