Late Life DepressionPhase 1NCT03368560
A Breathing-Based Meditation Intervention for Patients With Treatment Resistant Late Life Depression
A Phase 1 study testing Sudarshan Kriya Yoga in people with Late Life Depression, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
Trial summary
Late-life depression affects 2-8% of seniors and causes high rates of caregiver distress and risk of suicide. To exacerbate the problem, antidepressants, the cornerstone of therapy, are resistant in 55-80% of this population. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Late Life Depression
- What is being tested?
- Sudarshan Kriya Yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2020to 31 Dec 2022
- Phase
- Phase 1
- 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 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 60-80 years of age
- major depressive disorder, as per the results of an interview by a trained rater using the Structured Clinical Interview for DSM-5 and subsequently confirmed by the psychiatrist
- Mild to moderate depression as confirmed by a score on the HAM-D 17 between 8 and 23
- Have failed at least two trials of antidepressants, given at adequate doses for adequate duration during the current episode
- Able to follow verbal instructions and sit without physical discomfort for 45 minutes
- Willing and able to attend at least 75% of all Sudarshan Kriya Yoga (SKY) sessions
- Willing to dedicate 25-30 minutes/day to SKY practice at home
- Low risk of suicide based on a clinical initial interview and during follow-up interviews at weeks 4, 8 and 12.
Who cannot join
- Uncontrolled hypertension, seizure disorder, psychosis, substance abuse, or dementia
- Currently participating in other similar studies or currently practicing any type of formal meditation, mindfulness or breathing techniques
- A major surgery within 6 weeks prior to commencement of or scheduled during, the study intervention
- A traumatic brain injury
- Any contraindications to MRI will also be excluded
- Healthy control participants must have no significant mental health issues, or contraindications to MRI.
About this study
Official title: A Breathing-Based Meditation Intervention for Patients With Treatment-Resistant Late Life Depression (TR-LLD): A Phase II Trial and Feasibility Study
Late-life depression affects 2-8% of seniors and causes high rates of caregiver distress and risk of suicide. To exacerbate the problem, antidepressants, the cornerstone of therapy, are resistant in 55-80% of this population. Hence, this group of patients is labeled as having treatment-resistant late-life depression (TR-LLD).
Non-pharmacological interventions like meditation could offer significant benefits as augmentation strategies to improve response rate of antidepressants in TR-LLD. One such breath-based meditation intervention called Sudarshan Kriya Yoga is of interest based on highly significant preliminary data in adult patients with treatment-resistant depression, its scalability and relatively low cost to learn this lifelong skill.
Thirty patients diagnosed with TR-LLD will learn this intervention over 5 consecutive days by a certified para-professional trainer. This will be followed by 3 weekly 90 min follow-up sessions and then bimonthly sessions for 8 more weeks. SKY consists of a series of breathing techniques, including Sudarshan Kriya (SK), a sequential rhythm-specific breathing exercise. Participants will be asked to practice this technique for 25-30 minutes daily over the next 11 weeks. The investigators will collect clinical as well as feasibility outcome measures. The investigators will also explore if it is feasible to assess the antioxidant Glutathione (GSH) in the brain using a sophisticated magnetic resonance spectroscopy. The investigators suspect that GSH levels are reduced in TR-LLD and they will improve with SKY.
Read the detailed description
RECRUITMENT AND CONSENT:
Patients will be recruited from Victoria Hospital, London Health Sciences Centre or Parkwood Mental Health, St. Joseph's Health Care London. Patients will be screened and recruited after giving valid consent.
STUDY INTERVENTION (Sudarshan Kriya Yoga, SKY):
The 30 recruited TR-LLD participants will be invited to attend training sessions on SKY. The SKY program is a highly structured and standardized mind-body resilience building program. Through SKY breathing, interactive discussions, journaling, yoga and guided meditations, the workshop builds a framework for resilience and empowerment, and develops self-awareness, connectedness and community, and a positive outlook. This is a minimally invasive treatment and is not routinely available as standard of care. SKY involves rhythmic, cyclical forms of breathing in which there are no pauses between inhalation and exhalation. The breathing practices of this program include: (a) a three-stage Pranayama with Ujjayi, also called Victory Breath or Ocean Breath (b) Bhastrika or Bellow's Breath and (c) Sudarshan Kriya (SK) or the Rhythmic Breath Technique.
SKY will be consistently taught to the participants by two instructors from The Art of Living Foundation, an international humanitarian and charitable organization. SKY training will take place in a group-format with group sizes varying between 4-6 participants. The investigators will conduct these training sessions in an appropriately sized and accessible community hall in London, Ontario. SKY training involves attending a 5-day course that teaches the basic principles of SKY over 2.5-3 hour daily sessions. These will be followed by once weekly follow up sessions (90 min/wk) for 3 weeks and then bimonthly sessions (every 2 weeks) for the next 8 weeks. In addition, participants will be asked to practice SKY at home daily (25 min/day) throughout the duration of the study period and log practice frequency and any other noteworthy observations in a log sheet that will be provided to them.
MENTAL HEALTH ASSESSMENTS:
Participants will be screened for eligibility using criteria described below , the Anti-Depressant Treatment History Form, and if applicable an MRI pre-screening checklist. Prior to the start of the intervention, trained raters will meet with eligible participants to obtain demographic information. Participants will complete baseline measures of depression, comorbid anxiety, quality of life and caregiver burden. Specifically, the following scales will be administered: Hamilton Depression Rating Scale (HAM-D 17 item version), Geriatric Anxiety Inventory, European Quality of Life (EQ-5D-5L) and the Zaritz Caregiver burden. The abovementioned scales will be administered again at three other time points, weeks 4, 8 and 12.
MRI:
Seven healthy control participants will be recruited by advertising via flyers in waiting areas of the clinic. In addition, spouses and other family members accompanying the patient, who appear to be of eligible age, will be offered a letter of information about this research study. All thirty recruited TR-LLD participants will also be offered the option of participating in the MRI portion of the study in addition to the study activities described above. Our goal is to recruit 13 TR-LLD to complete MRI scans.
All MRI participants will complete the MRI screening questionnaire. Control participants will additionally be asked to complete a Mini Neuropsychiatric Interview (MINI) to confirm an absence of any mental health diagnosis. Both control and TR-LLD participants who are eligible to take part in the MRI portion of the study will be asked to attend a one-hour appointment at the Western Centre for Functional and Metabolic Mapping at University Hospital campus of LHSC. Control participants will attend only one such appointment, while TR-LLD participants will be asked to attend one MRI visit pre-intervention and one MRI visit post-intervention. The Research Coordinator or Research Assistant will accompany participants to the MRI visit, while the MRI analysis itself will be completed by an in-house MRI technician at the Western Centre for Functional and Metabolic Mapping.
The investigators will conduct semi-structured interviews by trained raters on study completers as well as drop outs. If a participant consented to be part of the study but then decided against participation at any point, he/she will be offered the opportunity to identify any problems with our approach by participating in a short interview conducted by a trained research assistant.
- Conditions
- Late Life Depression
- Being tested
- Sudarshan Kriya Yoga
- Keywords
- Treatment-resistant Late Life Depression, Sudarshan Kriya Yoga, Glutathione
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sudarshan Kriya YogaOther
Sudarshan Kriya Yoga (SKY): A 12-week training course conducted by certified instructors from the Art of Living Foundation. SKY training will take place in group-format (group sizes of 8-15 participants) in an appropriately sized and accessible community hall in London, Ontario.SKY training involves attending a week-long (5 days) course that teaches the basic principles of SKY over 2.5-3 hour daily sessions. This will be followed by once weekly follow up sessions (90 min/wk) for 3 weeks and then bimonthly sessions (every 2 weeks) for the next 8 weeks. In addition, participants will be asked to practice SKY at home daily (25 min/day) throughout the duration of the study period and log practice frequency and any other noteworthy observations in a log sheet that will be provided to them . Nutritional snacks will be provided during the 5 day SKY training course.
| Study group | Role | What they receive |
|---|---|---|
| Sudarshan Kriya Yoga | Active comparator | Thirty participants with treatment-resistant late life depression (TR-LLD) will attend 5 instructional days of Sudarshan Kriya Yoga (SKY), followed by 3 weekly follow-ups, and 8 weeks of bimonthly follow-ups. Participants will also practice SKY for 25 minutes per day at home. These participants will attend 4 mental health assessments at weeks 0, 4, 8, and 12. Thirteen of the recruited TR-LLD will attend an MRI at baseline and post-intervention. Receives: Other: Sudarshan Kriya Yoga |
| Control | No intervention | The seven recruited age-matched controls will complete a screening appointment and an MRI only for comparison. Demographic information will also be collected from the control participants. These individuals will not undergo the study intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of TR-LLD as measured by the Hamilton Depression Scale (HAM-D17).
The primary outcome measure will be the Hamilton Depression Rating Scale (HAM-D 17) score. The HAM-D17 rates symptoms commonly associated with Major Depressive Disorder (MDD). A total score is calculated based on the first 17 questions of the HAM-D with a score range of 0 to 53. A higher score indicates more severe depression, and a lower score indicates fewer and/or less severe symptoms of depression.
Measured: 12 weeks
Secondary outcomes (4)
Glutathione levels measured by a 7-Tesla Magnetic Resonance Imaging (7T-MRI) in TR-LLD.
Brain glutathione (GSH) levels, a measure of inflammatory stress, will be measured in the prefrontal cortex at baseline and after 12-weeks of SKY intervention via sophisticated magnetic resonance spectroscopy for TR-LLD. Control participants will complete one such measurement.
Measured: 12 weeks
Caregiver burden in caregivers of TR-LLD as measured by the Zaritz Caregiver Burden scale.
The Zaritz Caregiver Burden scale will be administered to caregivers of TR-LLD participants. This scale indicates the burden placed on caregivers by providing care for TR-LLD patients. A total score will be calculated, with scores ranging from 0 to 88. A lower score indicates little to no burden while a higher score indicates severe burden.
Measured: 12 weeks
Quality of Life of TR-LLD participants using the European Quality of Life (EQ-5D-5L) scale.
The European Quality of Life (EQ-5D-5L) scale will be used to assess the quality of life of study participants. This scale has two scores; the descriptive system and the EQ Visual Analogue scale (EQ VAS). The descriptive system consists of 5 questions each with 5 possible answers allowing for 5 possible health states. A score of 1 indicates no problems with the 5 measured dimensions, while a score of 5 would indicate the most severe possible state for each dimension. The descriptive system includes 5 sub-scores ranging from 1 (no issues) to 5 (severe problems), which will be converted to a specific single index value. The EQ VAS consists of only one question ranging from 0 (worst possible state of health) to 100 (best possible state of health).
Measured: 12 weeks
Anxiety severity of TR-LLD participants measured by the Geriatric Anxiety Inventory (GAI).
The Geriatric Anxiety Inventory (GAI) assesses anxiety in geriatric patients. The questionnaire consists of 20 agree or disagree questions with total scores ranging from 0 (no anxiety) to 20 (severe anxiety).
Measured: 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start1 Jan 2020 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Why it stopped: Funding was not received.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Late Life DepressionStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- This study will recruit 30 patients with treatment-resistant late life depression, and 7 age-matched controls.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Akshya Vasudev, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03368560
- Sponsor's protocol ID
- 110791
- Status last verified
- Jun 2018
- First submitted
- 27 Nov 2017
- Last updated
- 25 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Breathing-Based Meditation Intervention for Patients With Treatment-Resistant Late Life Depression (TR-LLD): A Phase II Trial and Feasibility Study
- ClinicalTrials.gov ID
- NCT03368560
- Acronym / sponsor ID
- 110791
- Conditions
- Late Life Depression
- Keywords
- Treatment-resistant Late Life Depression, Sudarshan Kriya Yoga, Glutathione
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding was not received.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 11 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.
Late-life depression affects 2-8% of seniors and causes high rates of caregiver distress and risk of suicide. To exacerbate the problem, antidepressants, the cornerstone of therapy, are resistant in 55-80% of this population. Hence, this group of patients is labeled as having treatment-resistant late-life depression (TR-LLD).
Non-pharmacological interventions like meditation could offer significant benefits as augmentation strategies to improve response rate of antidepressants in TR-LLD. One such breath-based meditation intervention called Sudarshan Kriya Yoga is of interest based on highly significant preliminary data in adult patients with treatment-resistant depression, its scalability and relatively low cost to learn this lifelong skill.
Thirty patients diagnosed with TR-LLD will learn this intervention over 5 consecutive days by a certified para-professional trainer. This will be followed by 3 weekly 90 min follow-up sessions and then bimonthly sessions for 8 more weeks. SKY consists of a series of breathing techniques, including Sudarshan Kriya (SK), a sequential rhythm-specific breathing exercise. Participants will be asked to practice this technique for 25-30 minutes daily over the next 11 weeks. The investigators will collect clinical as well as feasibility outcome measures. The investigators will also explore if it is feasible to assess the antioxidant Glutathione (GSH) in the brain using a sophisticated magnetic resonance spectroscopy. The investigators suspect that GSH levels are reduced in TR-LLD and they will improve with SKY.
Detailed description
RECRUITMENT AND CONSENT:
Patients will be recruited from Victoria Hospital, London Health Sciences Centre or Parkwood Mental Health, St. Joseph's Health Care London. Patients will be screened and recruited after giving valid consent.
STUDY INTERVENTION (Sudarshan Kriya Yoga, SKY):
The 30 recruited TR-LLD participants will be invited to attend training sessions on SKY. The SKY program is a highly structured and standardized mind-body resilience building program. Through SKY breathing, interactive discussions, journaling, yoga and guided meditations, the workshop builds a framework for resilience and empowerment, and develops self-awareness, connectedness and community, and a positive outlook. This is a minimally invasive treatment and is not routinely available as standard of care. SKY involves rhythmic, cyclical forms of breathing in which there are no pauses between inhalation and exhalation. The breathing practices of this program include: (a) a three-stage Pranayama with Ujjayi, also called Victory Breath or Ocean Breath (b) Bhastrika or Bellow's Breath and (c) Sudarshan Kriya (SK) or the Rhythmic Breath Technique.
SKY will be consistently taught to the participants by two instructors from The Art of Living Foundation, an international humanitarian and charitable organization. SKY training will take place in a group-format with group sizes varying between 4-6 participants. The investigators will conduct these training sessions in an appropriately sized and accessible community hall in London, Ontario. SKY training involves attending a 5-day course that teaches the basic principles of SKY over 2.5-3 hour daily sessions. These will be followed by once weekly follow up sessions (90 min/wk) for 3 weeks and then bimonthly sessions (every 2 weeks) for the next 8 weeks. In addition, participants will be asked to practice SKY at home daily (25 min/day) throughout the duration of the study period and log practice frequency and any other noteworthy observations in a log sheet that will be provided to them.
MENTAL HEALTH ASSESSMENTS:
Participants will be screened for eligibility using criteria described below , the Anti-Depressant Treatment History Form, and if applicable an MRI pre-screening checklist. Prior to the start of the intervention, trained raters will meet with eligible participants to obtain demographic information. Participants will complete baseline measures of depression, comorbid anxiety, quality of life and caregiver burden. Specifically, the following scales will be administered: Hamilton Depression Rating Scale (HAM-D 17 item version), Geriatric Anxiety Inventory, European Quality of Life (EQ-5D-5L) and the Zaritz Caregiver burden. The abovementioned scales will be administered again at three other time points, weeks 4, 8 and 12.
MRI:
Seven healthy control participants will be recruited by advertising via flyers in waiting areas of the clinic. In addition, spouses and other family members accompanying the patient, who appear to be of eligible age, will be offered a letter of information about this research study. All thirty recruited TR-LLD participants will also be offered the option of participating in the MRI portion of the study in addition to the study activities described above. Our goal is to recruit 13 TR-LLD to complete MRI scans.
All MRI participants will complete the MRI screening questionnaire. Control participants will additionally be asked to complete a Mini Neuropsychiatric Interview (MINI) to confirm an absence of any mental health diagnosis. Both control and TR-LLD participants who are eligible to take part in the MRI portion of the study will be asked to attend a one-hour appointment at the Western Centre for Functional and Metabolic Mapping at University Hospital campus of LHSC. Control participants will attend only one such appointment, while TR-LLD participants will be asked to attend one MRI visit pre-intervention and one MRI visit post-intervention. The Research Coordinator or Research Assistant will accompany participants to the MRI visit, while the MRI analysis itself will be completed by an in-house MRI technician at the Western Centre for Functional and Metabolic Mapping.
The investigators will conduct semi-structured interviews by trained raters on study completers as well as drop outs. If a participant consented to be part of the study but then decided against participation at any point, he/she will be offered the opportunity to identify any problems with our approach by participating in a short interview conducted by a trained research assistant.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study will recruit 30 patients with treatment-resistant late life depression, and 7 age-matched controls.
| Arm | Type | Receives |
|---|---|---|
| Sudarshan Kriya Yoga | Active comparator | Other: Sudarshan Kriya YogaThirty participants with treatment-resistant late life depression (TR-LLD) will attend 5 instructional days of Sudarshan Kriya Yoga (SKY), followed by 3 weekly follow-ups, and 8 weeks of bimonthly follow-ups. Participants will also practice SKY for 25 minutes per day at home. These participants will attend 4 mental health assessments at weeks 0, 4, 8, and 12. Thirteen of the recruited TR-LLD will attend an MRI at baseline and post-intervention. |
| Control | No intervention | –The seven recruited age-matched controls will complete a screening appointment and an MRI only for comparison. Demographic information will also be collected from the control participants. These individuals will not undergo the study intervention. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 60-80 years of age
- major depressive disorder, as per the results of an interview by a trained rater using the Structured Clinical Interview for DSM-5 and subsequently confirmed by the psychiatrist
- Mild to moderate depression as confirmed by a score on the HAM-D 17 between 8 and 23
- Have failed at least two trials of antidepressants, given at adequate doses for adequate duration during the current episode
- Able to follow verbal instructions and sit without physical discomfort for 45 minutes
Key exclusion criteria (6 listed)
- Uncontrolled hypertension, seizure disorder, psychosis, substance abuse, or dementia
- Currently participating in other similar studies or currently practicing any type of formal meditation, mindfulness or breathing techniques
- A major surgery within 6 weeks prior to commencement of or scheduled during, the study intervention
- A traumatic brain injury
- Any contraindications to MRI will also be excluded
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 YogaSudarshan Kriya Yoga (SKY): A 12-week training course conducted by certified instructors from the Art of Living Foundation. SKY training will take place in group-format (group sizes of 8-15 participants) in an appropriately sized and accessible community hall in London, Ontario.SKY training involves attending a week-long (5 days) course that teaches the basic principles of SKY over 2.5-3 hour daily sessions. This will be followed by once weekly follow up sessions (90 min/wk) for 3 weeks and then bimonthly sessions (every 2 weeks) for the next 8 weeks. In addition, participants will be asked to practice SKY at home daily (25 min/day) throughout the duration of the study period and log practice frequency and any other noteworthy observations in a log sheet that will be provided to them . Nutritional snacks will be provided during the 5 day SKY training course. | Other | Sudarshan Kriya Yoga |
Primary outcome
Severity of TR-LLD as measured by the Hamilton Depression Scale (HAM-D17).
Time frame: 12 weeks
The primary outcome measure will be the Hamilton Depression Rating Scale (HAM-D 17) score. The HAM-D17 rates symptoms commonly associated with Major Depressive Disorder (MDD). A total score is calculated based on the first 17 questions of the HAM-D with a score range of 0 to 53. A higher score indicates more severe depression, and a lower score indicates fewer and/or less severe symptoms of depression.
4 secondary outcomes
Glutathione levels measured by a 7-Tesla Magnetic Resonance Imaging (7T-MRI) in TR-LLD.
Time frame: 12 weeks
Caregiver burden in caregivers of TR-LLD as measured by the Zaritz Caregiver Burden scale.
Time frame: 12 weeks
Quality of Life of TR-LLD participants using the European Quality of Life (EQ-5D-5L) scale.
Time frame: 12 weeks
Anxiety severity of TR-LLD participants measured by the Geriatric Anxiety Inventory (GAI).
Time frame: 12 weeks.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2018.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sudarshan Kriya Yoga in people with Late Life Depression, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
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 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: withdrawn, as of the sponsor's last update on 25 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was withdrawn before enrolling participants, so there are no results.
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?
Severity of TR-LLD as measured by the Hamilton Depression Scale (HAM-D17). (time frame: 12 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 25 Jun 2018.