Bipolar DisorderNCT00482482
Yoga in Unipolar and Bipolar Disorders
A study testing psychoeducation and Yoga in people with Bipolar Disorder and Major Depression, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bipolar Disorder, Major Depression, Dysthymia
- What is being tested?
- psychoeducation and Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2007to Mar 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients meeting DSM-IV-TR diagnostic criteria for either Major Depression, Dysthymia, Bipolar I or Bipolar II disorder
- 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
Who cannot join
- Participants currently in a Manic, Hypomanic, or Mixed Phase
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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:
- 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.
- Conditions
- Bipolar Disorder, Major Depression, Dysthymia
- Being tested
- psychoeducation, Yoga
- Keywords
- Yoga, Bipolar disorder, Major depression, Dysthymia, Randomized
- Medical subject headings
- Bipolar Disorder, Depressive Disorder, Major, Dysthymic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychoeducationBehavioural
on weekly basis for 8 weeks
YogaBehavioural
on weekly basis for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Yoga | Experimental | Yoga was offered twice a week for 8 weeks, 1.5 hours per session Receives: Behavioral: Yoga |
| Psychoeducation | Active comparator | Psychoeducation was offered twice a week for 8 weeks, 1.5 hours per session Receives: Behavioral: psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Asberg Depression Rating Scale (MADRS)
Measured: Start of study, 8 weeks and 16 weeks
Secondary outcomes (6)
Salivary cortisol levels
Measured: Start of study, 8 weeks, 16 weeks
Clinical Global Impression Scale
Measured: Start of study, 8 weeks and 16 weeks
Quality of Life Enjoyment and Satisfaction Scale
Measured: Start of study, 8 weeks and 16 weeks
Perceived Stress Scale
Measured: Start of study, 8 weeks and 16 weeks
Coping Strategies Scale
Measured: Start of study, 8 weeks and 16 weeks
Beck Depression Inventory
Measured: Start of study, 8 weeks and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2007 (estimated)
- Study startSep 2007
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arun Ravindran, Centre for Addiction and Mental Health
- Investigators
- Arun Ravindran, MD, PhD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00482482
- Sponsor's protocol ID
- 308/2006
- Status last verified
- Dec 2012
- First submitted
- 1 Jun 2007
- Last updated
- 5 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Effectiveness of Yoga as Augmentation in Improving Residual Depressive Symptoms in Unipolar and Bipolar Disorders.
- ClinicalTrials.gov ID
- NCT00482482
- Acronym / sponsor ID
- 308/2006
- Conditions
- Bipolar Disorder, Major Depression, Dysthymia
- Keywords
- Yoga, Bipolar disorder, Major depression, Dysthymia, Randomized
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 5 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga | Experimental | Behavioral: YogaYoga was offered twice a week for 8 weeks, 1.5 hours per session |
| Psychoeducation | Active comparator | Behavioral: psychoeducationPsychoeducation was offered twice a week for 8 weeks, 1.5 hours per session |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patients meeting DSM-IV-TR diagnostic criteria for either Major Depression, Dysthymia, Bipolar I or Bipolar II disorder
- 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
Key exclusion criteria (6 listed)
- Participants currently in a Manic, Hypomanic, or Mixed Phase
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| psychoeducationon weekly basis for 8 weeks | Behavioural | Psychoeducation |
| Yogaon weekly basis for 8 weeks | Behavioural | Yoga |
Primary outcome
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: Start of study, 8 weeks and 16 weeks
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2012.
- Information about research at the Centre for Addiction and Mental HealthLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arun Ravindran, MD, PhD principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing psychoeducation and Yoga in people with Bipolar Disorder and Major Depression, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montgomery-Asberg Depression Rating Scale (MADRS) (time frame: Start of study, 8 weeks and 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2012.