Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00482482
Status:
COMPLETED
Last Update Posted:
2012-12-05
First Post:
2007-06-01
Brief Title:
Yoga in Unipolar and Bipolar Disorders
Sponsor:
Centre for Addiction and Mental Health
Organization:
Centre for Addiction and Mental Health
Study Overview
Official Title:
The Safety and Effectiveness of Yoga as Augmentation in Improving Residual Depressive Symptoms in Unipolar and Bipolar Disorders
Status:
COMPLETED
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 relapserecurrence of mood episodes over 1 year in subjects with unipolar and bipolar disorders
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 relapserecurrence 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 dateYoga 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 ie receiving either one or two mood stabilizers 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
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 dateYoga 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 ie receiving either one or two mood stabilizers 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None