Major Depressive DisorderPhase 2NCT02616549
Multicomponent Yoga Intervention for Major Depressive Disorder
A Phase 2 study testing Sudarshan Kriya Yoga in people with Major Depressive Disorder, run by University of Pennsylvania at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the efficacy of a multi-component yoga intervention featuring Sudarshan Kriya Yoga (SKY) as an adjunctive treatment for patients with Major Depressive Disorders with incomplete response to antidepressants. Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Sudarshan Kriya Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Dec 2015
- Phase
- Phase 2
- 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 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DSM-IV Major Depressive Disorder
- Able to give informed consent
- Aged 18-67
- Currently in outpatient care for MDD
- On a stable antidepressant regimen for at least 2 months
- 17-item Hamilton Depression Score >14 at screening \& baseline visit
Who cannot join
- Currently in crisis requiring inpatient treatment
- Bipolar Disorder, Psychotic Disorder, ADHD, Substance Use Disorder
- Pregnancy, Epilepsy
- Initiating psychotherapy or other yoga/meditation program
Trial locations and contacts
1 site in 1 country.
United States1 site
Mood & Anxiety Disorders Research and Treatment Program
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Randomized Study of a Comprehensive Yoga Intervention for Patients With Major Depressive Disorder With Incomplete Response to Antidepressants
The purpose of this study is to evaluate the efficacy of a multi-component yoga intervention featuring Sudarshan Kriya Yoga (SKY) as an adjunctive treatment for patients with Major Depressive Disorders with incomplete response to antidepressants.
Read the detailed description
According to the World Health Organization, compared to two hundred health conditions, depression is ranked as the second leading cause of disability worldwide. The annual prevalence of Major Depressive Disorder (MDD) in the United States is estimated at 7% and the lifetime risk approximately 17%. Depression is associated with approximately 75% of all deaths by suicide, resulting in immense suffering for families and society at large. 83 billion dollars are spent per year on treatment and lost productivity related to the disorder. Current treatments for MDD have remission rates between 35-50%. Patients who respond to treatment, but do not experience clinical remission are at markedly increased risk for relapse. Approximately 50% of patients treated with two trials of antidepressant interventions do not achieve clinical remission. Consequently, novel evidence-based treatment modalities that can further treat this devastating disorder are needed. Mind-body interventions constitute a large and diverse group of practices that reduce both stress and inflammation and are increasingly being evaluated in the treatment of MDD The 2007 NHIS concluded that 16.6% of U.S. adults, representing 34.1 million Americans, used at least one mind-body intervention in the past year. Initial studies with different mind-body interventions have been shown to improve outcomes in MDD. A recent meta-analysis gave a Grade B for current evidence for the use of yoga as an intervention for MDD. Sudarshan Kriya Yoga (SKY) is a advanced yogic breathing intervention that has been reported to relieve symptoms of major depressive disorder and generalized anxiety disorder. In MDD, SKY can correct the P300 amplitude, decrease plasma cortisol levels and increase plasma prolactin levels. In a small-scale randomized controlled trial, 45 consenting inpatients meeting criteria for DSM-IV severe, melancholic depression were randomized to receive SKY, electroconvulsive therapy (ECT) or imipramine treatment for four weeks (Janakiramaiah et al. 2000). Consequently, the rigorous evaluation of a multicomponent yogic intervention featuring SKY as an adjunctive treatment for adults with MDD warrants further study.
- Conditions
- Major Depressive Disorder
- Being tested
- Sudarshan Kriya Yoga
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sudarshan Kriya YogaBehavioural
A manual-based yoga program featuring a yoga-breathing meditation technique
| Study group | Role | What they receive |
|---|---|---|
| Sudarshan Kriya Yoga | Experimental | Not described Receives: Behavioral: Sudarshan Kriya Yoga |
| Waitlist Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
17-item Hamilton Depression Rating Scale
Measured: Baseline to 2 month
Secondary outcomes (3)
Beck Depression Inventory
Measured: Baseline to 2 month
Beck Anxiety Inventory
Measured: Baseline to 2 month
Columbia Suicide Severity Rating Scale
Measured: Baseline, 1 month, 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2015 (estimated)
- Study startOct 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02616549
- Sponsor's protocol ID
- 820672
- Status last verified
- Dec 2015
- First submitted
- 23 Nov 2015
- Last updated
- 8 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Sharma A, Barrett MS, Cucchiara AJ, Gooneratne NS, Thase ME. A Breathing-Based Meditation Intervention for Patients With Major Depressive Disorder Following Inadequate Response to Antidepressants: A Randomized Pilot Study. J Clin Psychiatry. 2017 Jan;78(1):e59-e63. doi: 10.4088/JCP.16m10819.
PubMed 27898207
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of a Comprehensive Yoga Intervention for Patients With Major Depressive Disorder With Incomplete Response to Antidepressants
- ClinicalTrials.gov ID
- NCT02616549
- Acronym / sponsor ID
- 820672
- Conditions
- Major Depressive Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 30 Nov 2015 (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.
The purpose of this study is to evaluate the efficacy of a multi-component yoga intervention featuring Sudarshan Kriya Yoga (SKY) as an adjunctive treatment for patients with Major Depressive Disorders with incomplete response to antidepressants.
Detailed description
According to the World Health Organization, compared to two hundred health conditions, depression is ranked as the second leading cause of disability worldwide. The annual prevalence of Major Depressive Disorder (MDD) in the United States is estimated at 7% and the lifetime risk approximately 17%. Depression is associated with approximately 75% of all deaths by suicide, resulting in immense suffering for families and society at large. 83 billion dollars are spent per year on treatment and lost productivity related to the disorder. Current treatments for MDD have remission rates between 35-50%. Patients who respond to treatment, but do not experience clinical remission are at markedly increased risk for relapse. Approximately 50% of patients treated with two trials of antidepressant interventions do not achieve clinical remission. Consequently, novel evidence-based treatment modalities that can further treat this devastating disorder are needed. Mind-body interventions constitute a large and diverse group of practices that reduce both stress and inflammation and are increasingly being evaluated in the treatment of MDD The 2007 NHIS concluded that 16.6% of U.S. adults, representing 34.1 million Americans, used at least one mind-body intervention in the past year. Initial studies with different mind-body interventions have been shown to improve outcomes in MDD. A recent meta-analysis gave a Grade B for current evidence for the use of yoga as an intervention for MDD. Sudarshan Kriya Yoga (SKY) is a advanced yogic breathing intervention that has been reported to relieve symptoms of major depressive disorder and generalized anxiety disorder. In MDD, SKY can correct the P300 amplitude, decrease plasma cortisol levels and increase plasma prolactin levels. In a small-scale randomized controlled trial, 45 consenting inpatients meeting criteria for DSM-IV severe, melancholic depression were randomized to receive SKY, electroconvulsive therapy (ECT) or imipramine treatment for four weeks (Janakiramaiah et al. 2000). Consequently, the rigorous evaluation of a multicomponent yogic intervention featuring SKY as an adjunctive treatment for adults with MDD warrants further study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sudarshan Kriya Yoga | Experimental | Behavioral: Sudarshan Kriya Yoga |
| Waitlist Control | No intervention | – |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- DSM-IV Major Depressive Disorder
- Able to give informed consent
- Aged 18-67
- Currently in outpatient care for MDD
- On a stable antidepressant regimen for at least 2 months
Key exclusion criteria (4 listed)
- Currently in crisis requiring inpatient treatment
- Bipolar Disorder, Psychotic Disorder, ADHD, Substance Use Disorder
- Pregnancy, Epilepsy
- Initiating psychotherapy or other yoga/meditation program
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 |
|---|---|---|
| Sudarshan Kriya YogaA manual-based yoga program featuring a yoga-breathing meditation technique | Behavioural | Sudarshan Kriya Yoga |
Primary outcome
17-item Hamilton Depression Rating Scale
Time frame: Baseline to 2 month
3 secondary outcomes
Beck Depression Inventory
Time frame: Baseline to 2 month
Beck Anxiety Inventory
Time frame: Baseline to 2 month
Columbia Suicide Severity Rating Scale
Time frame: Baseline, 1 month, 2 month
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 8 Dec 2015.
- Derived from this study: PubMed 27898207Sharma A, Barrett MS, Cucchiara AJ, Gooneratne NS, Thase ME. A Breathing-Based Meditation Intervention for Patients With Major Depressive Disorder Following Inadequate Response to Antidepressants: A Randomized Pilot Study. J Clin Psychiatry. 2017 Jan;78(1):e59-e63. doi: 10.4088/JCP.16m10819.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sudarshan Kriya Yoga in people with Major Depressive Disorder, run by University of Pennsylvania at 1 site in United States.
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 6 inclusion and 4 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 8 Dec 2015. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
17-item Hamilton Depression Rating Scale (time frame: Baseline to 2 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02616549, which also lists 1 linked publication.
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 8 Dec 2015.