NCT00482482

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 relapse/recurrence of mood episodes over 1 year, in subjects with unipolar and bipolar disorders.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2007

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

December 5, 2012

Status Verified

December 1, 2012

Enrollment Period

3.5 years

First QC Date

June 1, 2007

Last Update Submit

December 4, 2012

Conditions

Bipolar DisorderMajor DepressionDysthymia

Keywords

YogaBipolar disorderMajor depressionDysthymiaRandomized

Outcome Measures

Primary Outcomes (1)

  • Montgomery-Asberg Depression Rating Scale (MADRS)

    Start of study, 8 weeks and 16 weeks

Secondary Outcomes (6)

  • Salivary cortisol levels

    Start of study, 8 weeks, 16 weeks

  • Clinical Global Impression Scale

    Start of study, 8 weeks and 16 weeks

  • Quality of Life Enjoyment and Satisfaction Scale

    Start of study, 8 weeks and 16 weeks

  • Perceived Stress Scale

    Start of study, 8 weeks and 16 weeks

  • Coping Strategies Scale

    Start of study, 8 weeks and 16 weeks

  • +1 more secondary outcomes

Study Arms (2)

Yoga

EXPERIMENTAL

Yoga was offered twice a week for 8 weeks, 1.5 hours per session

Behavioral: Yoga

Psychoeducation

ACTIVE COMPARATOR

Psychoeducation was offered twice a week for 8 weeks, 1.5 hours per session

Behavioral: psychoeducation

Interventions

psychoeducationBEHAVIORAL

on weekly basis for 8 weeks

Psychoeducation
YogaBEHAVIORAL

on weekly basis for 8 weeks

Yoga

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Addition and Mental Health

Toronto, Ontario, M5T 1R8, Canada

Location

Related Links

MeSH Terms

Conditions

Bipolar DisorderDepressive Disorder, MajorDysthymic Disorder

Interventions

Yoga

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersDepressive Disorder

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Arun Ravindran, MD, PhD

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Division of Mood and Anxiety Disorders

Study Record Dates

First Submitted

June 1, 2007

First Posted

June 5, 2007

Study Start

September 1, 2007

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

December 5, 2012

Record last verified: 2012-12

Locations

CA(1)