SchizophreniaSATYAMNCT03379480
Study on Examination of Therapeutic Efficacy and Potential Mechanisms of Yoga Treatment in Schizophrenia
A study testing Yoga arm in people with Schizophrenia, run by National Institute of Mental Health and Neuro Sciences, India at 1 site in India.
Trial summary
The aim of this study is to examine whether yoga is efficacious as an add-on treatment for negative symptoms of schizophrenia in a randomized multi-centric trial and also to examine functional brain changes associated with self-reflection after treatment with yoga. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Yoga arm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteIndia
- Study dates
- 11 Nov 2016to Jun 2020
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Schizophrenia Subject
- ICD (International Classification of Diseases) 10 diagnosis of schizophrenia
- capacity to provide informed consent, as evaluated by the MacArthur Competence Assessment Tool for Clinical Research
- no other current comorbid axis I diagnosis (except nicotine abuse/dependence) and no general impaired intellectual functioning
- Healthy volunteers:
- Males and females between 18 and 45 years
- Capacity to provide informed consent
- absence of past or present psychiatric illnesses including substance abuse 4) no general impaired intellectual functioning (MMSE above24)
Who cannot join
- Other current comorbid axis I diagnosis (except nicotine abuse/dependence) and general impaired intellectual functioning
- History of alcohol or substance abuse or dependence in the last 12 months (with the exception of nicotine)
- Any Contraindication to MRI like metal implants or paramagnetic objects within the body or claustrophobia (only for patients undergoing fMRI at NIMHANS)
- Past history of head injury resulting in loss of consciousness or neurosurgery
- Concomitant severe medical conditions
- Change in dose of antipsychotic medication or Electroconvulsive therapy in the past 6weeks
- Pregnant or lactating -
Trial locations and contacts
1 site in 1 country.
India1 site
National Institute of Mental Health and Neurosciences
Bangalore, Karnataka, 560029
About this study
Official title: Examination of Therapeutic Efficacy and Potential Mechanisms of Yoga Treatment in Schizophrenia
The aim of this study is to examine whether yoga is efficacious as an add-on treatment for negative symptoms of schizophrenia in a randomized multi-centric trial and also to examine functional brain changes associated with self-reflection after treatment with yoga.
- Conditions
- Schizophrenia
- Being tested
- Yoga arm
- Keywords
- Schizophrenia, Yoga, fMRI
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga armBehavioural
Yoga module developed for patients with Schizophrenia
| Study group | Role | What they receive |
|---|---|---|
| Yoga arm | Active comparator | Patients with Schizophrenia will undergo 12 sessions of yoga. According to randomization one group of patients will start yoga immediately after recruitment ,whereas another group will go into wait list for 12 weeks after which they will also undergo Yoga treatment. Receives: Behavioral: Yoga arm |
| Control arm | No intervention | Healthy volunteers who will not receive yoga. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in negative symptoms in patients with schizophrenia
Schizophrenia patients receiving yoga as add-on treatment will have significant improvement in negative symptoms after yoga therapy compared to those in the wait-list group as reflected by a greater decrease in Scale for Assessment of negative symptoms score. This scale measures negative symptoms on a 25 item, 6-point scale. Items are listed under the five domains of affective blunting, alogia, avolition/apathy, anhedonia/asociality, and attention. A higher score indicates greater severity.
Measured: At the end of 12 weeks of yoga
Secondary outcomes (1)
fMRI changes
Schizophrenia patients receiving yoga will have higher activation in Medial prefrontal cortex after yoga therapy compared to baseline and compared to those in the wait-list group at 12 weeks.
Measured: At the end of 12weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start11 Nov 2016
- Primary completionJun 2020
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health and Neuro Sciences, India
- Sponsor type
- University, hospital or other
- Collaborators
- SCARF (Schizophrenia Research Foundation ,India) Schizophrenia
- Responsible party
- Principal investigator, Dr Naren P Rao, National Institute of Mental Health and Neuro Sciences, India
- Investigators
- Naren P Rao, MD, Principal investigator, National Institute of Mental Health and Neuro Sciences, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03379480
- Sponsor's protocol ID
- DST/002/208/2016/00892
- Acronym
- SATYAM
- Status last verified
- Aug 2020
- First submitted
- 15 Dec 2017
- Last updated
- 28 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of Therapeutic Efficacy and Potential Mechanisms of Yoga Treatment in Schizophrenia
- ClinicalTrials.gov ID
- NCT03379480
- Acronym / sponsor ID
- SATYAM / DST/002/208/2016/00892
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Yoga, fMRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- National Institute of Mental Health and Neuro Sciences, IndiaUniversity, hospital or other
- Collaborators
- SCARF (Schizophrenia Research Foundation ,India) Schizophrenia
- Study start
- 11 Nov 2016 (actual)
- Primary completion
- Jun 2020 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 20 Dec 2017 (actual)
- 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 aim of this study is to examine whether yoga is efficacious as an add-on treatment for negative symptoms of schizophrenia in a randomized multi-centric trial and also to examine functional brain changes associated with self-reflection after treatment with yoga.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga arm | Active comparator | Behavioral: Yoga armPatients with Schizophrenia will undergo 12 sessions of yoga. According to randomization one group of patients will start yoga immediately after recruitment ,whereas another group will go into wait list for 12 weeks after which they will also undergo Yoga treatment. |
| Control arm | No intervention | –Healthy volunteers who will not receive yoga. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Schizophrenia Subject
- ICD (International Classification of Diseases) 10 diagnosis of schizophrenia
- capacity to provide informed consent, as evaluated by the MacArthur Competence Assessment Tool for Clinical Research
- no other current comorbid axis I diagnosis (except nicotine abuse/dependence) and no general impaired intellectual functioning
- Males and females between 18 and 45 years
Key exclusion criteria (7 listed)
- Other current comorbid axis I diagnosis (except nicotine abuse/dependence) and general impaired intellectual functioning
- History of alcohol or substance abuse or dependence in the last 12 months (with the exception of nicotine)
- Any Contraindication to MRI like metal implants or paramagnetic objects within the body or claustrophobia (only for patients undergoing fMRI at NIMHANS)
- Past history of head injury resulting in loss of consciousness or neurosurgery
- Concomitant severe medical conditions
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 |
|---|---|---|
| Yoga armYoga module developed for patients with Schizophrenia | Behavioural | Yoga arm |
Primary outcome
Improvement in negative symptoms in patients with schizophrenia
Time frame: At the end of 12 weeks of yoga
Schizophrenia patients receiving yoga as add-on treatment will have significant improvement in negative symptoms after yoga therapy compared to those in the wait-list group as reflected by a greater decrease in Scale for Assessment of negative symptoms score. This scale measures negative symptoms on a 25 item, 6-point scale. Items are listed under the five domains of affective blunting, alogia, avolition/apathy, anhedonia/asociality, and attention. A higher score indicates greater severity.
1 secondary outcome
fMRI changes
Time frame: At the end of 12weeks
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 28 Aug 2020.
- Individual participant dataSharing planned: Undecided
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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.
Naren P Rao, MD principal investigator
National Institute of Mental Health and Neuro Sciences, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga arm in people with Schizophrenia, run by National Institute of Mental Health and Neuro Sciences, India at 1 site in India.
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 8 inclusion and 7 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 28 Aug 2020. 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 India. 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?
Improvement in negative symptoms in patients with schizophrenia (time frame: At the end of 12 weeks of yoga). 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 28 Aug 2020.