Major Depressive DisorderNCT02079610
Effect of Amygdala Neurofeedback on Depressive Symptoms and Processing Biases
A study testing real-time fMRI neurofeedback: Amygdala and real-time fMRI neurofeedback: HIPS in people with Major Depressive Disorder, run by Laureate Institute for Brain Research, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine whether upregulating the left amygdala during positive autobiographical memory recall via real time functional magnetic resonance imaging neurofeedback will lead to an improvement in clinician administered ratings of depressive symptoms. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- real-time fMRI neurofeedback: Amygdala and real-time fMRI neurofeedback: HIPS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Apr 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- clinical diagnosis of major depressive disorder
- right handed
- adult aged 18-55
- currently depressed
Who cannot join
- clinically significant or unstable cardiovascular, pulmonary, endocrine, neurological, gastrointestinal illness or unstable medical disorder
- met Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for alcohol and/or substance abuse or substance dependence (other than nicotine) within 12 months prior to screening
- endorse suicidal intent or have made a suicide attempt within the preceding three months
- history of traumatic brain injury
- inability to complete MRI scan due to claustrophobia or general MRI exclusions (e.g., shrapnel inside body)
- current pregnancy or breast feeding
- a primary language other than English
- received psychotropic drugs for at least 3 weeks (8 weeks for fluoxetine) prior to scanning (Effective medications will not be discontinued for the purposes of the study)
Trial locations and contacts
1 site in 1 country.
United States1 site
Laureate Institute for Brain Research
Tulsa, Oklahoma, 74136
About this study
The purpose of this study is to determine whether upregulating the left amygdala during positive autobiographical memory recall via real time functional magnetic resonance imaging neurofeedback will lead to an improvement in clinician administered ratings of depressive symptoms. The investigators predict that patients with major depressive disorder receiving left amygdala neurofeedback will increase their amygdala response during positive autobiographical memory recall compared to those receiving control feedback from a region not involved in emotional processing and that this ability will be associated with clinically significant improvement.
Read the detailed description
Major depressive disorder (MDD) is the leading cause of years lived with disability worldwide. Traditional pharmacological and/or psychological interventions are ineffective in up to one-half of patients, and treatments (such as electroconvulsive therapy, vagus nerve stimulation, and deep brain stimulation) available for severely ill patients who do not respond to standard interventions are invasive, and associated with potentially significant side effects. Therefore, there is a need to explore and develop novel non-invasive treatments.
One such non-invasive method is real-time functional magnetic resonance imaging neurofeedback (rtfMRI-nf), which allows a person to see and regulate the fMRI signal from his or her own brain. Emerging evidence suggests rtfMRI-nf has clinical utility in reducing symptoms of chronic pain, tinnitus, and Parkinson's disease. The goal of the current study is to leverage recent advances in rtfMRI-nf to determine whether this procedure can be adapted as treatment for MDD. While amygdala activity is exaggerated in response to negative stimuli in MDD, evidence further suggests that the amygdala response to positive stimuli is attenuated in MDD and normalizes with remission. Therefore, the target for our rtfMRI-nf procedure is the left amygdala. Participants will be randomly assigned to receive rtfMRI-nf from either the left amygdala or the left horizontal segment of the intraparietal sulcus (HIPS; a region not involved in emotional processing) and to increase the activity within that region to a target level by thinking of positive autobiographical memories. This neurofeedback condition will alternate with periods of rest and counting backwards in order to allow participants to disengage from memory contemplation. A final run without neurofeedback information will be included to determine whether participants can maintain the learned amygdala elevation during positive memory recall in the absence of neurofeedback. Participants will complete two sessions within a one-week period. Clinical ratings will be taken at the time of each scan to determine whether the amygdala rtfMRI-nf procedure results in improvement of depression symptoms, and changes within the emotional regulation network that occur with successful amygdala regulation will be examined. Furthermore, the investigators aim to determine whether the rtfMRI-nf procedure will alter assessments of emotional processing conducted within three days prior to, and following completion of, the rtfMRI-nf procedure.
Specific Aim 1: In individuals with MDD, determine the degree to which rtfMRI-nf enhances voluntary control over neural activity in the amygdala, co-modulates other brain regions within the emotion regulation circuitry, and alters depressive symptom severity ratings.
- Hypothesis 1.1: MDD participants receiving rtfMRI-nf regarding blood oxygen-level dependent (BOLD) activity within their amygdala can learn to voluntarily regulate this activity in response to positive stimuli. MDD participants receiving rtfMRI-nf regarding left amygdala activity will demonstrate greater activity in this region while contemplating positive autobiographical memories (AMs) than MDD participants receiving rtfMRI-nf regarding BOLD activity in the left HIPS, a region not involved in emotion.
- Hypothesis 1.2: The investigators hypothesize enhancing control over the amygdala via rtfMRI-nf will increase connectivity strengths between the amygdala and prefrontal regions involved in modulating emotional behavior including the pregenual anterior cingulate cortex and ventromedial prefrontal cortex.
- Hypothesis 1.3: The investigators hypothesize participants showing the greatest enhancement of amygdala activity in response to rtfMRI-nf also will show the greatest improvement in depressive symptom severity ratings at the end of the study.
Specific Aim 2: In MDD patients, determine the degree to which rtfMRI-nf from the amygdala restores a normative mood-congruent processing bias during the processing of emotionally valenced stimuli.
- Hypothesis 2.1: During the performance of a backward masking task in which emotional faces are presented below conscious awareness, the investigators hypothesize MDD participants will initially show a processing bias toward negative stimuli in the amygdala that will reverse to a processing bias toward positive stimuli in participants receiving active vs HIPS rtfMRI-nf
- Hypothesis 2.2: The investigators hypothesize that MDD patients will initially show a mood-congruent processing bias toward negative stimuli on the P1Vital Emotional Test Battery that will reverse to a bias toward positive stimuli following amygdala (vs HIPS) rtfMRI-nf.
Results from this project will lead to new insights into the plastic neurobiological mechanisms that govern recovery from MDD and promote novel, non-invasive approaches to MDD treatment.
- Conditions
- Major Depressive Disorder
- Being tested
- real-time fMRI neurofeedback: Amygdala, real-time fMRI neurofeedback: HIPS
- Keywords
- Depression, Neurofeedback, Amygdala
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
real-time fMRI neurofeedback: AmygdalaBehavioural
Participants are shown activity from their left amygdala in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories.
real-time fMRI neurofeedback: HIPSBehavioural
Participants are shown activity from their left horizontal segment of the intraparietal sulcus in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories.
| Study group | Role | What they receive |
|---|---|---|
| real-time fMRI neurofeedback: Amygdala | Experimental | Amygdala neurofeedback - attempt to upregulate the left amygdala during positive autobiographical memory recall via real time fMRI neurofeedback from the amygdala. Two sessions will be performed one week apart. Receives: Behavioral: real-time fMRI neurofeedback: Amygdala |
| real-time fMRI neurofeedback: HIPS | Active comparator | HIPS neurofeedback - attempt to upregulate the left horizontal segment of the intraparietal sulcus (HIPS), a region not involved in emotional processing, during positive autobiographical memory recall via real time fMRI neurofeedback from the HIPS. Two sessions will be performed one week apart. Receives: Behavioral: real-time fMRI neurofeedback: HIPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Montgomery Asberg Depression Rating Scale at 2 Weeks
Depression symptom severity rating scale. The overall score ranges on MADRS are from from 0 to 60, with higher scores indicating more severe depression. Usual cutoff points are:
0 to 6 - normal /symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression
Measured: baseline and 2 weeks
Secondary outcomes (2)
Change From Baseline Beck Depression Inventory at 2 Weeks
Depression symptom severity rating scale. The overall score ranges on BDI are from from 0 to 63, with higher scores indicating more severe depression. Usual cutoff points are:
0 to 13 - normal /symptom absent 14 to 19 - mild depression 20 to 28 - moderate depression >29 - severe depression
Measured: baseline and 2 weeks
Change From Baseline Hamilton Rating Scale for Depression at 2 Weeks
Depression symptom severity rating scale. The overall score ranges on HDRS are from from 0 to 50, with higher scores indicating more severe depression. Usual cutoff points are:
0 to 7 - normal /symptom absent 8 to 16 - mild depression 17 to 23 - moderate depression >24 - severe depression
Measured: baseline and 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laureate Institute for Brain Research, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Kymberly D Young, PhD, Principal investigator, Laureate Institute for Brain Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02079610
- Sponsor's protocol ID
- 2013-013-00
- Other IDs
- 4R00MH101235-03
- Status last verified
- Jul 2017
- First submitted
- 4 Mar 2014
- Last updated
- 25 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Zotev V, Phillips R, Young KD, Drevets WC, Bodurka J. Prefrontal control of the amygdala during real-time fMRI neurofeedback training of emotion regulation. PLoS One. 2013 Nov 6;8(11):e79184. doi: 10.1371/journal.pone.0079184. eCollection 2013.
PubMed 24223175Zotev V, Krueger F, Phillips R, Alvarez RP, Simmons WK, Bellgowan P, Drevets WC, Bodurka J. Self-regulation of amygdala activation using real-time FMRI neurofeedback. PLoS One. 2011;6(9):e24522. doi: 10.1371/journal.pone.0024522. Epub 2011 Sep 8.
PubMed 21931738Young KD, Zotev V, Phillips R, Misaki M, Yuan H, Drevets WC, Bodurka J. Real-time FMRI neurofeedback training of amygdala activity in patients with major depressive disorder. PLoS One. 2014 Feb 11;9(2):e88785. doi: 10.1371/journal.pone.0088785. eCollection 2014.
PubMed 24523939Young KD, Siegle GJ, Zotev V, Phillips R, Misaki M, Yuan H, Drevets WC, Bodurka J. Randomized Clinical Trial of Real-Time fMRI Amygdala Neurofeedback for Major Depressive Disorder: Effects on Symptoms and Autobiographical Memory Recall. Am J Psychiatry. 2017 Aug 1;174(8):748-755. doi: 10.1176/appi.ajp.2017.16060637. Epub 2017 Apr 14.
PubMed 28407727
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Amygdala Neurofeedback on Depressive Symptoms and Processing Biases
- ClinicalTrials.gov ID
- NCT02079610
- Acronym / sponsor ID
- 2013-013-00
- Conditions
- Major Depressive Disorder
- Keywords
- Depression, Neurofeedback, Amygdala
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Laureate Institute for Brain Research, Inc.University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Apr 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 6 Mar 2014 (estimated)
- Results
- Posted 25 Sep 2017
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 determine whether upregulating the left amygdala during positive autobiographical memory recall via real time functional magnetic resonance imaging neurofeedback will lead to an improvement in clinician administered ratings of depressive symptoms. The investigators predict that patients with major depressive disorder receiving left amygdala neurofeedback will increase their amygdala response during positive autobiographical memory recall compared to those receiving control feedback from a region not involved in emotional processing and that this ability will be associated with clinically significant improvement.
Detailed description
Major depressive disorder (MDD) is the leading cause of years lived with disability worldwide. Traditional pharmacological and/or psychological interventions are ineffective in up to one-half of patients, and treatments (such as electroconvulsive therapy, vagus nerve stimulation, and deep brain stimulation) available for severely ill patients who do not respond to standard interventions are invasive, and associated with potentially significant side effects. Therefore, there is a need to explore and develop novel non-invasive treatments.
One such non-invasive method is real-time functional magnetic resonance imaging neurofeedback (rtfMRI-nf), which allows a person to see and regulate the fMRI signal from his or her own brain. Emerging evidence suggests rtfMRI-nf has clinical utility in reducing symptoms of chronic pain, tinnitus, and Parkinson's disease. The goal of the current study is to leverage recent advances in rtfMRI-nf to determine whether this procedure can be adapted as treatment for MDD. While amygdala activity is exaggerated in response to negative stimuli in MDD, evidence further suggests that the amygdala response to positive stimuli is attenuated in MDD and normalizes with remission. Therefore, the target for our rtfMRI-nf procedure is the left amygdala. Participants will be randomly assigned to receive rtfMRI-nf from either the left amygdala or the left horizontal segment of the intraparietal sulcus (HIPS; a region not involved in emotional processing) and to increase the activity within that region to a target level by thinking of positive autobiographical memories. This neurofeedback condition will alternate with periods of rest and counting backwards in order to allow participants to disengage from memory contemplation. A final run without neurofeedback information will be included to determine whether participants can maintain the learned amygdala elevation during positive memory recall in the absence of neurofeedback. Participants will complete two sessions within a one-week period. Clinical ratings will be taken at the time of each scan to determine whether the amygdala rtfMRI-nf procedure results in improvement of depression symptoms, and changes within the emotional regulation network that occur with successful amygdala regulation will be examined. Furthermore, the investigators aim to determine whether the rtfMRI-nf procedure will alter assessments of emotional processing conducted within three days prior to, and following completion of, the rtfMRI-nf procedure.
Specific Aim 1: In individuals with MDD, determine the degree to which rtfMRI-nf enhances voluntary control over neural activity in the amygdala, co-modulates other brain regions within the emotion regulation circuitry, and alters depressive symptom severity ratings.
- Hypothesis 1.1: MDD participants receiving rtfMRI-nf regarding blood oxygen-level dependent (BOLD) activity within their amygdala can learn to voluntarily regulate this activity in response to positive stimuli. MDD participants receiving rtfMRI-nf regarding left amygdala activity will demonstrate greater activity in this region while contemplating positive autobiographical memories (AMs) than MDD participants receiving rtfMRI-nf regarding BOLD activity in the left HIPS, a region not involved in emotion.
- Hypothesis 1.2: The investigators hypothesize enhancing control over the amygdala via rtfMRI-nf will increase connectivity strengths between the amygdala and prefrontal regions involved in modulating emotional behavior including the pregenual anterior cingulate cortex and ventromedial prefrontal cortex.
- Hypothesis 1.3: The investigators hypothesize participants showing the greatest enhancement of amygdala activity in response to rtfMRI-nf also will show the greatest improvement in depressive symptom severity ratings at the end of the study.
Specific Aim 2: In MDD patients, determine the degree to which rtfMRI-nf from the amygdala restores a normative mood-congruent processing bias during the processing of emotionally valenced stimuli.
- Hypothesis 2.1: During the performance of a backward masking task in which emotional faces are presented below conscious awareness, the investigators hypothesize MDD participants will initially show a processing bias toward negative stimuli in the amygdala that will reverse to a processing bias toward positive stimuli in participants receiving active vs HIPS rtfMRI-nf
- Hypothesis 2.2: The investigators hypothesize that MDD patients will initially show a mood-congruent processing bias toward negative stimuli on the P1Vital Emotional Test Battery that will reverse to a bias toward positive stimuli following amygdala (vs HIPS) rtfMRI-nf.
Results from this project will lead to new insights into the plastic neurobiological mechanisms that govern recovery from MDD and promote novel, non-invasive approaches to MDD treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| real-time fMRI neurofeedback: Amygdala | Experimental | Behavioral: real-time fMRI neurofeedback: AmygdalaAmygdala neurofeedback - attempt to upregulate the left amygdala during positive autobiographical memory recall via real time fMRI neurofeedback from the amygdala. Two sessions will be performed one week apart. |
| real-time fMRI neurofeedback: HIPS | Active comparator | Behavioral: real-time fMRI neurofeedback: HIPSHIPS neurofeedback - attempt to upregulate the left horizontal segment of the intraparietal sulcus (HIPS), a region not involved in emotional processing, during positive autobiographical memory recall via real time fMRI neurofeedback from the HIPS. Two sessions will be performed one week apart. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- clinical diagnosis of major depressive disorder
- right handed
- adult aged 18-55
- currently depressed
Key exclusion criteria (8 listed)
- clinically significant or unstable cardiovascular, pulmonary, endocrine, neurological, gastrointestinal illness or unstable medical disorder
- met Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for alcohol and/or substance abuse or substance dependence (other than nicotine) within 12 months prior to screening
- endorse suicidal intent or have made a suicide attempt within the preceding three months
- history of traumatic brain injury
- inability to complete MRI scan due to claustrophobia or general MRI exclusions (e.g., shrapnel inside body)
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 |
|---|---|---|
| real-time fMRI neurofeedback: AmygdalaParticipants are shown activity from their left amygdala in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories. | Behavioural | real-time fMRI neurofeedback: Amygdala |
| real-time fMRI neurofeedback: HIPSParticipants are shown activity from their left horizontal segment of the intraparietal sulcus in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories. | Behavioural | real-time fMRI neurofeedback: HIPS |
Primary outcome
Change From Baseline in Montgomery Asberg Depression Rating Scale at 2 Weeks
Time frame: baseline and 2 weeks
Depression symptom severity rating scale. The overall score ranges on MADRS are from from 0 to 60, with higher scores indicating more severe depression. Usual cutoff points are: 0 to 6 - normal /symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression
2 secondary outcomes
Change From Baseline Beck Depression Inventory at 2 Weeks
Time frame: baseline and 2 weeks
Change From Baseline Hamilton Rating Scale for Depression at 2 Weeks
Time frame: baseline and 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24223175Zotev V, Phillips R, Young KD, Drevets WC, Bodurka J. Prefrontal control of the amygdala during real-time fMRI neurofeedback training of emotion regulation. PLoS One. 2013 Nov 6;8(11):e79184. doi: 10.1371/journal.pone.0079184. eCollection 2013.
- Background: PubMed 21931738Zotev V, Krueger F, Phillips R, Alvarez RP, Simmons WK, Bellgowan P, Drevets WC, Bodurka J. Self-regulation of amygdala activation using real-time FMRI neurofeedback. PLoS One. 2011;6(9):e24522. doi: 10.1371/journal.pone.0024522. Epub 2011 Sep 8.
- Background: PubMed 24523939Young KD, Zotev V, Phillips R, Misaki M, Yuan H, Drevets WC, Bodurka J. Real-time FMRI neurofeedback training of amygdala activity in patients with major depressive disorder. PLoS One. 2014 Feb 11;9(2):e88785. doi: 10.1371/journal.pone.0088785. eCollection 2014.
- Derived from this study: PubMed 28407727Young KD, Siegle GJ, Zotev V, Phillips R, Misaki M, Yuan H, Drevets WC, Bodurka J. Randomized Clinical Trial of Real-Time fMRI Amygdala Neurofeedback for Major Depressive Disorder: Effects on Symptoms and Autobiographical Memory Recall. Am J Psychiatry. 2017 Aug 1;174(8):748-755. doi: 10.1176/appi.ajp.2017.16060637. Epub 2017 Apr 14.
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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.
Kymberly D Young, PhD principal investigator
Laureate Institute for Brain Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing real-time fMRI neurofeedback: Amygdala and real-time fMRI neurofeedback: HIPS in people with Major Depressive Disorder, run by Laureate Institute for Brain Research, Inc. 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 4 inclusion and 8 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 25 Sep 2017. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Montgomery Asberg Depression Rating Scale at 2 Weeks (time frame: baseline and 2 weeks). 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 NCT02079610, which also lists 4 linked publications.
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 Sep 2017.