Bipolar Disorder Clinical Trial
Official title:
The Safety and Effectiveness of Yoga as Augmentation in Improving Residual Depressive Symptoms in Unipolar and Bipolar Disorders.
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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