Bipolar Disorder study using Sudarshan Kriya Yoga for Treatment, Recruiting Subjects for Study

The goal of this study is to determine the safety and effectiveness of Sudarshan Kriya Yoga (SKY) as an add-on treatment to medication, in comparison to medication as usual in improving symptoms of Bipolar Depression over 4 weeks, and in prevention of relapse/recurrence of mood episodes over 1 year. The general symptoms of depression will be measured by rating scales and quality of life and overall severity of the illness will be explored and compared between the two groups.

The specific hypotheses are:

1. At week 4 (the end of the acute phase), SKY plus pharmacotherapy will be more effective than pharmacotherapy alone in treating sub-syndromal depressive symptoms as indicated by greater reduction in MADRS scores relative to baseline.
2. The time to emergence of new mood episode as determined by Kaplan Meier Survival Curves over 56 weeks will be longer than those randomized to SKY plus pharmacotherapy compared with those randomized to pharmacotherapy alone.

• MADRS score [Time Frame: 4 weeks]
• The difference in time to emergence of a mood episode or time to intervention between the SKY plus usual treatment and of usual treatment alone [Time Frame: Maintenance phase]

• YMRS
• HAM-D
• CGI
• BDI
• QLESQ
• Perceived Stress
• Coping Skills
• Sheehan Disability Scale

Bipolar depression remains a complex and vexing problem for the clinician. It is often difficult to treat and the benefit of antidepressants is questioned because of the increased risk of switch and rapid cycling. As well, bipolar patients often continue to experience residual symptoms (with consequent impact on function) and sub-syndromal symptoms increase the risk of relapse. SKY, a form of yoga, has been shown to be effective in the treatment of major depression and dysthymia in randomized, controlled trials.

Could adjunctive SKY treat sub-syndromal depressive symptoms and thus reduce the risk of relapse in bipolar patients? 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.

Bipolar depression is a complex and difficult disorder to treat condition. It is often associated with residual symptoms with significant functional impairment. Furthermore, long-term antidepressant use may increase the risk of switch to mania and rapid cycling. SKY (form of yoga) has shown to be beneficial in treating depressive symptoms but without the added risks associated with antidepressants and has the advantage of high consumer appeal (with likelihood of good compliance). SKY, 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 with Bipolar Disorder.

This is a prospective, assessor-blind, randomized controlled study, and will be carried out in two phases:

1. 4-week acute treatment phase and
2. 1 year maintenance phase. 40 patients meeting DSM-IV-TR diagnostic criteria for either 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.

In the acute treatment phase, patients will be randomized in addition to their standard pharmacotherapy, to one of two treatment groups 1) Sudarshan Kriya Yoga (SKY); or 2) pharmacotherapy as usual. After completion of this phase, regardless of treatment response, patients will have the option to participate in the maintenance phase of the study. During this phase, patients will continue with whichever augmentation treatment they received during the intensive treatment phase (SKY, or pharmacotherapy as usual), at a reduced frequency, for a period of one year.

Inclusion Criteria:

• Male or female patients meeting DSM-IV-TR diagnostic criteria for either Bipolar I or Bipolar II disorder
• MADRS score of ≥8 and ≤16 and a YMRS score of ≤8
• Age 18 to 75 years; 4)Free of significant physical illness
• Participants taking prophylactic pharmacotherapy for Bipolar disorder, i.e. receiving either one or two mood stabilizer(s), or in combination with an oral atypical antipsychotic or lamotrigine or an antidepressant.

Exclusion Criteria: 1)Exclusion Criteria:

• Participants currently in a Manic, Hypomanic, or Mixed Episode
• History of psychosis not due to Bipolar Disorder, e.g. schizophrenia, schizoaffective disorder, etc.
• Alcohol or Substance Abuse/Dependence within past 3 months
• Participants currently receiving any systematic structured psychotherapy. Supportive therapy is allowed
• Major medical illness or physical impairment that impacting ability to participate in the study as evidenced by medical history, physical exam, and clinical investigations