Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2007-09-30
2011-03-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Yoga
Yoga was offered twice a week for 8 weeks, 1.5 hours per session
Yoga
on weekly basis for 8 weeks
Psychoeducation
Psychoeducation was offered twice a week for 8 weeks, 1.5 hours per session
psychoeducation
on weekly basis for 8 weeks
Interventions
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psychoeducation
on weekly basis for 8 weeks
Yoga
on weekly basis for 8 weeks
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
75 Years
ALL
No
Sponsors
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Centre for Addiction and Mental Health
OTHER
Responsible Party
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Arun Ravindran
Chief, Division of Mood and Anxiety Disorders
Principal Investigators
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Arun Ravindran, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Centre for Addiction and Mental Health
Locations
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Centre for Addition and Mental Health
Toronto, Ontario, Canada
Countries
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Related Links
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Information about research at the Centre for Addiction and Mental Health
Other Identifiers
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308/2006
Identifier Type: -
Identifier Source: org_study_id