Executive DysfunctionNCT03745768

iTBS Study for Depression (Randomized)

A study testing Intermittent Theta Burst Stimulation in people with Executive Dysfunction and Depression, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 60 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Executive Dysfunction, Depression
What is being tested?: Intermittent Theta Burst Stimulation
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 19 participants
Where: 1 siteUnited States
Study dates: 5 Apr 2018to 1 Apr 2020
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 60 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Age ≥ 60 - 85 years old
Diagnosis of major depressive disorder (MDD), single or recurrent, with a current Major depression episode as diagnosed by the Mini-international Neuropsychiatric Interview (MINI 6.0)
Montgomery Asberg Depression Scale score greater than or equal to 15 at baseline.
Evidence of decreased executive function as evidenced by either of the following conditions: a) scoring below the mean normative scaled score on the average of the NIH Toolbox executive function measures: Flanker inhibitory control and attention test and the Dimensional sort card test, approximate score 70 - 100 as per PI discretion. b) Discrepancy of at least 10 points between the average of the picture vocabulary score and the reading recognition test score and the average of the Flanker inhibitory control and dimensional card sort test score. c) Frontal Systems Behavior Scale (FRSBE) T scores above 60 (indicative of borderline to clinically significant impairment) and at least 10 points (1 Standard Deviation) above subject's premorbid (pre-depression) scores.

Who cannot join

Inability to complete NIH tool box cognitive testing
Inability to provide informed consent
<22 score on the Montreal Cognitive Assessment MoCA indicative of moderate to severe cognitive impairment per PI discretion
Lifetime diagnosis of bipolar I or II disorder or psychotic disorder as per the MINI interview
current psychotic symptoms
alcohol or other substance use disorder per DSM V criteria in the past 6 months

Show all 18Show fewer

High risk for suicide (active suicidal ideation/intent or plan and patient is unsafe to be in the outpatient setting), an urgent psychiatric referral will be made in those cases
Have a diagnosis of obsessive compulsive disorder, post-traumatic stress disorder (current or within the last year), anxiety disorder (generalized anxiety disorder, social anxiety disorder, panic disorder), assessed by a study investigator to be primary
Previous history of TMS
history of failure to an adequate course of electroconvulsive therapy (ECT) such as equal or more than 7-9 electroconvulsive therapy treatments, per PI discretion
Major unstable medical illness including advanced/uncontrolled diabetes, hypertension, renal disease or advanced cancer, per PI discretion
Psychotropic use other than antidepressants (e.g., Benzodiazepines [more than 2mg of lorazepam equivalent daily], anticonvulsants [except low dose of Neurontin approximately 600mg/day] or cognitive enhancers such as N-Methyl D - Aspartate (NDMA) receptor antagonists [Memantine HCL], psychostimulants [such as methylphenidate or modafinil]) per PI discretion
Recent changes or initiation of antidepressant therapy approximately in the last 4 weeks prior to intervention delivery, per PI discretion
if participating in psychotherapy, must have been in stable treatment for at least 3 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the study
contraindications for TMS including the presence of metallic objects within 30 cm of the TMS coil, intracranial implants (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed; presence of intracardiac lines, defibrillators or a cardiac pacemaker and unable to assess safety; presence of implanted electronic devices that control physiologic functions and unable to assess safety
have a personal history of a primary seizure disorder or a seizure associated with an intracranial lesion
History of severe head trauma or neurological disorders that substantially increase seizure risk, per PI discretion
non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview).

Trial locations and contacts

1 site in 1 country.

United States1 site

Washington University in St. Louis School of Medicine - Healthy Mind Lab
St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Intermittent Theta Burst Stimulation to Relieve Depression and Concurrent Executive Function Impairment in Older Adults: A Randomized Controlled Study

Executive function deficits are common in late life depression (LLD) and are associated with resistance to antidepressants, poor quality of life, considerable disability and increased suicidal risk. This study uses a novel type of Transcranial Magnetic Stimulation called intermittent Theta Burst Stimulation (iTBS). iTBS delivers high frequency (50Hz) magnetic pulses in "bursts" of 3 stimuli. It is posited that this intervention induces plasticity in the human cortex. Theoretical and empirical evidence from research studies informs that iTBS can improve depression and executive deficits, however, this has not been examined in older adults.

This project examines iTBS's ability to improve depression and executive impairment in LLD. It also tests the effects of iTBS on brain connectivity within the Cognitive Control Network (CCN). This study will enhance understanding of LLD, providing critical pilot data to develop future randomized controlled clinical trials.

Both active and sham interventions are administered sequentially to the left and right dorso-lateral prefrontal cortex. The total stimulation time is about 7 minutes. These interventions are administered for 6 weeks (Monday-Friday). 20 subjects will be randomized. Changes in mood from baseline to the end of study are measured with the Montgomery-Asberg Depression Rating Scale. Executive function at baseline and end of study are evaluated with the National Institutes of Health Toolbox executive domain battery. Safety assessments include: the 21 item Scale for suicidal ideation SSI. The frequency, intensity and burden of side effects rating (FIBSER) and the Altman Self Rating Mania scale (ASRM). Ancillary depression measures include the Quick Inventory of Depressive Symptoms (QIDS) and the Clinical Global Impression of Improvement scale.

Subjects undergo functional Magnetic Resonance Imaging (fMRI) before and after the study interventions to test the effects of iTBS on the brain's functional connectivity.

This research will provide meaningful information about the effects of iTBS on mood and executive function in older adults as well as information regarding its effects on brain function. Results of this pilot study will inform a grant submission and allow investigators to calculate power for a definitive randomized controlled clinical trial to test the efficacy of iTBS versus placebo.

Conditions: Executive Dysfunction, Depression
Being tested: Intermittent Theta Burst Stimulation, sham stimulation
Keywords: depression, executive dysfunction, transcranial magnetic stimulation, intermittent theta burst stimulation, neuromodulation, older adults, geriatrics
Medical subject headings: Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intermittent Theta Burst StimulationDevice
Intermittent theta burst stimulation delivered to the dorsolateral prefrontal cortex on the left and right sides of the brain for 6 weeks.
sham stimulationDevice
Sham stimulation delivered to the dorsolateral prefrontal cortex on the left and right sides of the brain for 6 weeks.

Study groups in NCT03745768
Study group	Role	What they receive
Active iTBS Treatment	Experimental	Participants received Intermittent theta burst stimulation to the dorsolateral prefrontal cortex for 6 weeks Receives: Device: Intermittent Theta Burst Stimulation
Sham Stimulation	Sham comparator	Participants received Sham stimulation to the dorsolateral prefrontal cortex for 6 weeks. Receives: Device: sham stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Montgomery-Asberg Depression Rating Scale (MADRS) Scores From Baseline to the End of the Intervention
We will assess the efficacy of iTBS in improving mood by determining if older adults randomized to iTBS will show significant decreases in the Montgomery-Asberg Depression Rating Scale consistent with improvement of depressive symptoms. The total score for the scale will be reported. The total scores range is 0 - 60 with 0 = minimum score and 60 the maximum score. A low score is better as it denotes less depressive symptoms.
Measured: 6 weeks
Change in the NIH Toolbox Executive Domain Measure Flanker Inhibitory Control and Attention Test
Improvement in executive function in participants will be assessed by determining if subjects randomized to iTBS show significant increases in their NIH Toolbox Flanker Inhibitory control and attention test from baseline to the end of 6 weeks, compared to those randomized to sham.
NIH Tool box Flanker inhibitory control and attention test is a validated instrument measuring attention and inhibitory control.
The age corrected standard score is used, for which the normative mean is 100 and the standard deviation is 15. This score compares the score of the test taker to those in the NIH tool box nationally representative sample at the same age, where a score of 100 indicates performance that was at the national average for the test-taking participant's age. A score of 115 or 85 for example would indicate that the participant's performance is 1SD above or below the national average respectively, when compared with like-aged participants. Higher scores indicate higher performance.
Measured: 6 weeks
Change in the NIH Tool Box Executive Measure Dimensional Change Card Sort Test
Improvement in executive function in participants will be assessed by determining if subjects randomized to iTBS show significant increases in their NIH Toolbox Dimensional change card sort test from baseline to the end of 6 weeks, compared to those randomized to sham.
NIH Tool box Dimensional change card sort test is a validated instrument measuring cognitive flexibility.
The age corrected standard score is used, for which the normative mean is 100 and the standard deviation is 15. This score compares the score of the test taker to those in the NIH tool box nationally representative sample at the same age, where a score of 100 indicates performance that was at the national average for the test-taking participant's age. A score of 115 or 85 for example would indicate that the participant's performance is 1SD above or below the national average respectively, when compared with like-aged participants. Higher scores indicate higher performance.
Measured: 6 weeks
Change in the NIH Tool Box List Sorting Working Memory Measure
Improvement in executive function in participants will be assessed by determining if subjects randomized to iTBS show significant increases in their NIH Toolbox list sorting working memory test from baseline to the end of 6 weeks, compared to those randomized to sham.
NIH Tool box list sorting working memory test is a validated instrument measuring working memory.
The age corrected standard score is used, for which the normative mean is 100 and the standard deviation is 15. This score compares the score of the test taker to those in the NIH tool box nationally representative sample at the same age, where a score of 100 indicates performance that was at the national average for the test-taking participant's age. A score of 115 or 85 for example would indicate that the participant's performance is 1SD above or below the national average respectively, when compared with like-aged participants. Higher scores indicate higher performance.
Measured: 6 weeks
Connectivity Change Within the CNN, Fronto-parietal Network
We will test the effects of iTBS on functional connectivity within the CNN ( fronto-parietal network) in depressed older adults obtained using resting state fMRI measuring BOLD signal in the brain.
Depressed older adults randomized to iTBS versus sham will have a significant increase in functional connectivity within the fronto-parietal network from baseline to week 6.
Measured: 6 weeks
Connectivity Change Within the CNN, Cingulo Opercular Network
We will test the effects of iTBS on functional connectivity within the CNN cingulo opercular network in depressed older adults obtained using resting state fMRI measuring bold signal in the brain.
Depressed older adults randomized to iTBS versus sham will have a significant increase in functional connectivity within the cingulo-opercular network from baseline to week 6.
Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Apr 20181 Apr 2020

First posted19 Nov 2018
Study start5 Apr 2018
Primary completion1 Apr 2020
Study completion1 Apr 2020

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.
Other trials for Executive DysfunctionStudies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomized controlled clinical trial testing iTBS versus sham
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03745768
Sponsor's protocol ID: 201803023
Status last verified: Jun 2022
First submitted: 14 Nov 2018
Last updated: 6 Jul 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: Individual participant data may be available upon request to be shared with other researchers interested in geriatric depression and resting state functional connectivity analysis.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Strengthening Neuro-Cognitive Skills for Success in School, Work and Beyond
TBI, Cognitive Dysfunction
Active, not recruitingPhase 3
Goal-Directed Sedation in Mechanically Ventilated Infants and Children
Delirium, Critical Illness
Active, not recruiting
Learning by Heart: The Effectiveness of an EF Training Program for Pre-schoolers With Critical CHD
Congenital Heart Disease, Executive Dysfunction
Recruiting
Executive Function Intervention for Children With Complex Congenital Heart Disease
Heart Defect, Congenital, Executive Dysfunction
Active, not recruiting
COMPuter-assisted Self-training to Improve EXecutive Function
Parkinson Disease, Stroke

All Executive Dysfunction trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intermittent Theta Burst Stimulation to Relieve Depression and Concurrent Executive Function Impairment in Older Adults: A Randomized Controlled Study
ClinicalTrials.gov ID: NCT03745768
Acronym / sponsor ID: 201803023
Conditions: Executive Dysfunction, Depression
Keywords: depression, executive dysfunction, transcranial magnetic stimulation, intermittent theta burst stimulation, neuromodulation, older adults, geriatrics
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Study start: 5 Apr 2018 (actual)
Primary completion: 1 Apr 2020 (actual)
Study completion: 1 Apr 2020 (actual)
First posted: 19 Nov 2018 (actual)
Results: Posted 6 Jul 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Subjects undergo functional Magnetic Resonance Imaging (fMRI) before and after the study interventions to test the effects of iTBS on the brain's functional connectivity.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Randomized controlled clinical trial testing iTBS versus sham

Arm	Type	Receives
Active iTBS Treatment	Experimental	Device: Intermittent Theta Burst StimulationParticipants received Intermittent theta burst stimulation to the dorsolateral prefrontal cortex for 6 weeks
Sham Stimulation	Sham comparator	Device: sham stimulationParticipants received Sham stimulation to the dorsolateral prefrontal cortex for 6 weeks.

Who may qualify

Ages: 60 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Age ≥ 60 - 85 years old
Diagnosis of major depressive disorder (MDD), single or recurrent, with a current Major depression episode as diagnosed by the Mini-international Neuropsychiatric Interview (MINI 6.0)
Montgomery Asberg Depression Scale score greater than or equal to 15 at baseline.
Evidence of decreased executive function as evidenced by either of the following conditions: a) scoring below the mean normative scaled score on the average of the NIH Toolbox executive function measures: Flanker inhibitory control and attention test and the Dimensional sort card test, approximate score 70 - 100 as per PI discretion. b) Discrepancy of at least 10 points between the average of the picture vocabulary score and the reading recognition test score and the average of the Flanker inhibitory control and dimensional card sort test score. c) Frontal Systems Behavior Scale (FRSBE) T scores above 60 (indicative of borderline to clinically significant impairment) and at least 10 points (1 Standard Deviation) above subject's premorbid (pre-depression) scores.

Key exclusion criteria (18 listed)

Inability to complete NIH tool box cognitive testing
Inability to provide informed consent
<22 score on the Montreal Cognitive Assessment MoCA indicative of moderate to severe cognitive impairment per PI discretion
Lifetime diagnosis of bipolar I or II disorder or psychotic disorder as per the MINI interview
current psychotic symptoms

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
Intermittent Theta Burst StimulationIntermittent theta burst stimulation delivered to the dorsolateral prefrontal cortex on the left and right sides of the brain for 6 weeks.	Device	Active iTBS Treatment
sham stimulationSham stimulation delivered to the dorsolateral prefrontal cortex on the left and right sides of the brain for 6 weeks.	Device	Sham Stimulation

Primary outcome

Change in Montgomery-Asberg Depression Rating Scale (MADRS) Scores From Baseline to the End of the Intervention
Time frame: 6 weeks
We will assess the efficacy of iTBS in improving mood by determining if older adults randomized to iTBS will show significant decreases in the Montgomery-Asberg Depression Rating Scale consistent with improvement of depressive symptoms. The total score for the scale will be reported. The total scores range is 0 - 60 with 0 = minimum score and 60 the maximum score. A low score is better as it denotes less depressive symptoms.
Change in the NIH Toolbox Executive Domain Measure Flanker Inhibitory Control and Attention Test
Time frame: 6 weeks
Improvement in executive function in participants will be assessed by determining if subjects randomized to iTBS show significant increases in their NIH Toolbox Flanker Inhibitory control and attention test from baseline to the end of 6 weeks, compared to those randomized to sham. NIH Tool box Flanker inhibitory control and attention test is a validated instrument measuring attention and inhibitory control. The age corrected standard score is used, for which the normative mean is 100 and the standard deviation is 15. This score compares the score of the test taker to those in the NIH tool box nationally representative sample at the same age, where a score of 100 indicates performance that was at the national average for the test-taking participant's age. A score of 115 or 85 for example would indicate that the participant's performance is 1SD above or below the national average respectively, when compared with like-aged participants. Higher scores indicate higher performance.
Change in the NIH Tool Box Executive Measure Dimensional Change Card Sort Test
Time frame: 6 weeks
Improvement in executive function in participants will be assessed by determining if subjects randomized to iTBS show significant increases in their NIH Toolbox Dimensional change card sort test from baseline to the end of 6 weeks, compared to those randomized to sham. NIH Tool box Dimensional change card sort test is a validated instrument measuring cognitive flexibility. The age corrected standard score is used, for which the normative mean is 100 and the standard deviation is 15. This score compares the score of the test taker to those in the NIH tool box nationally representative sample at the same age, where a score of 100 indicates performance that was at the national average for the test-taking participant's age. A score of 115 or 85 for example would indicate that the participant's performance is 1SD above or below the national average respectively, when compared with like-aged participants. Higher scores indicate higher performance.
Change in the NIH Tool Box List Sorting Working Memory Measure
Time frame: 6 weeks
Improvement in executive function in participants will be assessed by determining if subjects randomized to iTBS show significant increases in their NIH Toolbox list sorting working memory test from baseline to the end of 6 weeks, compared to those randomized to sham. NIH Tool box list sorting working memory test is a validated instrument measuring working memory. The age corrected standard score is used, for which the normative mean is 100 and the standard deviation is 15. This score compares the score of the test taker to those in the NIH tool box nationally representative sample at the same age, where a score of 100 indicates performance that was at the national average for the test-taking participant's age. A score of 115 or 85 for example would indicate that the participant's performance is 1SD above or below the national average respectively, when compared with like-aged participants. Higher scores indicate higher performance.
Connectivity Change Within the CNN, Fronto-parietal Network
Time frame: 6 weeks
We will test the effects of iTBS on functional connectivity within the CNN ( fronto-parietal network) in depressed older adults obtained using resting state fMRI measuring BOLD signal in the brain. Depressed older adults randomized to iTBS versus sham will have a significant increase in functional connectivity within the fronto-parietal network from baseline to week 6.
Connectivity Change Within the CNN, Cingulo Opercular Network
Time frame: 6 weeks
We will test the effects of iTBS on functional connectivity within the CNN cingulo opercular network in depressed older adults obtained using resting state fMRI measuring bold signal in the brain. Depressed older adults randomized to iTBS versus sham will have a significant increase in functional connectivity within the cingulo-opercular network from baseline to week 6.

Results and safety

Results posted to the registry on 6 Jul 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active iTBS Treatment	10	8
Sham Stimulation	9	9

Primary outcome: Change in Montgomery-Asberg Depression Rating Scale (MADRS) Scores From Baseline to the End of the Intervention

Time frame: 6 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Active iTBS Treatment n = 8	Sham Stimulation n = 9
Value	10.25 (6.40)	13.33 (3.70)

Primary outcome: Change in the NIH Toolbox Executive Domain Measure Flanker Inhibitory Control and Attention Test

Time frame: 6 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Active iTBS Treatment n = 8	Sham Stimulation n = 9
Value	1.38 (8.7)	0.78 (7.42)

Primary outcome: Change in the NIH Tool Box Executive Measure Dimensional Change Card Sort Test

Time frame: 6 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Active iTBS Treatment n = 8	Sham Stimulation n = 9
Value	1.00 (10.98)	-1.67 (11.02)

Primary outcome: Change in the NIH Tool Box List Sorting Working Memory Measure

Time frame: 6 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Active iTBS Treatment n = 8	Sham Stimulation n = 9
Value	-0.88 (10.77)	-7.00 (14.22)

Adverse events

Time frame: Each participant was assessed for adverse events from baseline (pre-intervention) to the end of of six weeks of the intervention.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active iTBS Treatment	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Sham Stimulation	0 of 9 (0%)	0 of 9 (0%)	0 of 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Individual participant data may be available upon request to be shared with other researchers interested in geriatric depression and resting state functional connectivity analysis.

Related trials for Executive Dysfunction

Recruiting
Strengthening Neuro-Cognitive Skills for Success in School, Work and Beyond
TBI, Cognitive Dysfunction
Active, not recruitingPhase 3
Goal-Directed Sedation in Mechanically Ventilated Infants and Children
Delirium, Critical Illness
Active, not recruiting
Learning by Heart: The Effectiveness of an EF Training Program for Pre-schoolers With Critical CHD
Congenital Heart Disease, Executive Dysfunction
Recruiting
Executive Function Intervention for Children With Complex Congenital Heart Disease
Heart Defect, Congenital, Executive Dysfunction
Active, not recruiting
COMPuter-assisted Self-training to Improve EXecutive Function
Parkinson Disease, Stroke

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.

Pilar Cristancho, MD principal investigator

Washington University School of Medicine in St. Louis

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Intermittent Theta Burst Stimulation in people with Executive Dysfunction and Depression, run by Washington University School of Medicine 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 18 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 6 Jul 2022. 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. Some participants in this study may receive a placebo. 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 6 Jul 2022). 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 in Montgomery-Asberg Depression Rating Scale (MADRS) Scores From Baseline to the End of the Intervention (time frame: 6 weeks). The study lists 6 primary outcomes in all. 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 NCT03745768.

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 6 Jul 2022.