COpenhagen Magnetic Personalized Accelerated Brain Circuit Therapy for Treatment Resistant Depression (CoMPACT)

The Copenhagen Magnetic Personalized Accelerated Brain Circuit Therapy (CoMPACT) Trial

The CoMPACT trial is a randomized double-blinded sham-controlled study aimed at testing a novel accelerated and personalized transcranial Magnetic Stimulation (TMS) treatment for patients with Treatment Resistant Depression (TRD).

CoMPACT consists of 25 sessions of intermittent theta-burst transcranial stimulation (iTBS) consisting of high inter-pulse frequency administered five times daily over five consecutive days.

The trial will include 78 patients with TRD who will be randomly assigned to one of three groups:

  • Group 1: Real CoMPACT targeting the left dorsolateral prefrontal cortex (DLPFC).
  • Group 2: Real CoMPACT targeting a novel site, the left inferior parietal lobule (IPL).
  • Group 3: Sham CoMPACT targeting the left DLPFC (50%, Group 3a) or left IPL (50%, Group 3b).

The hypothesis is that real prefrontal or parietal CoMPACT targeting will significantly alleviate depression symptoms compared to sham targeting, without compromising safety, feasibility, or tolerability.

The trial incorporates a personalized approach, using electrical field (E-field) modeling based on individual structural brain scans to tailor and standardize iTBS, ensuring accurate targeting of cortical volume and consistent induced electrical field strength. To delineate the treatment mechanism of action at the brain network level, multi brain mapping models will be implemented. Electroencephalography (EEG) records of spontaneous and TMS-evoked electrical brain activity will be obtained before, during, and after iTBS sessions to understand how the high frequency burst protocol functionally engages the stimulated cortex. Structural and functional brain MRI before and after the treatment will be used to study changes in depression-related brain networks. This will offer key insights into how CoMPACT affects depression-related brain networks and may identify neuroimaging markers for predicting treatment response, and thus informing future TBS treatments for TRD.

Study Overview

Detailed Description

Repetitive TMS (rTMS) of left DLPFC was approved by the US Food and Drug Administration (FDA) in 2008 as a therapy TRD, and this was extended to the equally effective iTBS protocol in 2018.

Dysfunctional connectivity between the left DLPFC and subgenual anterior cingulate cortex (sgACC) has been implicated in the pathogenesis of depression. It has been hypothesized that rTMS-induced neuroplasticity in left DLPFC modifies functional connectivity between left DLPFC and sgACC, normalizing the underlying brain circuit dysfunction.

A recent development has been a move towards "accelerated" rTMS protocols with more than one session per day. Recently, two studies reported promising results for the Stanford Accelerated Intelligent Neuromodulation Treatment (SAINT) protocol for TRD.

The aim of the COMPACT trial is to introduce and test a novel accelerated iTBS therapy for TRD that is designed to significantly expand existing work on accelerated iTBS.

The novel CoMPACT protocol utilizes high frequency bursts to produce a strong "acceleration" effect, securing therapeutic efficacy and clinical feasibility.

The COMPACT protocol consists of five iTBS sessions per day (rather than 10 sessions per day as given in the "SAINT" protocol) over five consecutive days to increase feasibility. In addition to accelerated iTBS of left DLPFC, the invetigators will test clinical efficacy of a novel parietal target, the left IPL. The investigators hypothesize that accelerated iTBS of the area in left IPL that shows a strong negative functional connectivity with the sgACC will be also highly effective in treating TRD compared to the accelerated sham protocol.

Anatomically guided personalized targeting and dosing will be based on E-field modeling informed by the individual cortical anatomy revealed by the patient's structural brain MRI.

Patients with TRD are recruited from psychiatric departments in Copenhagen. Information material with contact details for the project will be available in waiting rooms at the outpatient clinics so that potential participants can contact the project themselves. Furthermore, we will recruit by advertising via Trialtree.dk After inclusion, participants will undergo a baseline assessment (T0) that includes evaluating depression severity and several widely used psychiatric rating scales measuring anhedonia, cognitive deficits, and treatment-related adverse effects. A list of the tests included can be found in the "Outcome" section.

Within two weeks after T0, patients will undergo 5 days of active iTBS targeting either the left DLPFC or the left IPL, or a sham intervention on the left DLPFC or IPL, for a total of 25 sessions. During the first and last day of intervention week, EEG will be used recorded before, during and after first and last iTBS sessions. This helps to investigate acute changes in the cortical activity patterns induced by a single iTBS and the cumulative functional effects on cortical activity caused by the CoMPACT protocol.

Moreover, EEG response to a single and multi TMS pulse, so-called transcranial evoked potentials (TEPs), will be measured before and after iTBS session. This will allow us to explore how high-frequency burst iTBS modulates cortical excitation and inhibition in targeted regions and its potential correlation with clinical response. Online EEG monitoring during iTBS will be performed can also be used to document safety and capture brain activity during the periods separating consecutive iTBS trains.

The antidepressive effects of the intervention (Hamilton Depression Rating Scale as primary outcome) will be assessed, within 3 days after the last session. The rest of the clinical tests will be performed within 5 days after end of treatment (T1). The long-term effect on symptom of depression and other clinical effect will be tested after 4 weeks (T2) and at potential 6 months follow-up.

Assessments at T0 and T1 will also include structural (T1 and T2 weighted sequences), diffusion sensitive MRI, resting-state, and task-based functional MRI (fMRI). Task-related fMRI will reveal how the active CoMPACT intervention modifies brain activity and connectivity within key brain networks compared to sham COMPACT. Cognitive performance will be also probed using a selected set of cognitive tests at T0, T1 and T2.Referral to standard TMS therapy for non-responders:

If patients have not entered remission (i.e. a score less than 7 on HDS-17) immediately after the end of COMPACT treatment or at visit T1, they will be offered standard TMS treatment. A treatment that is approved for general clinical use in psychiatric wards and elsewhere.

Data will be collected at the participating sites in the Capital Region of Denmark (RegionH). After end of trial and final data analysis, anonymized trial-related data and methods will be made available to other researchers through public databases after publication of the main clinical outcome paper in accordance with Danish law.

Study Type

Interventional

Enrollment (Estimated)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Glostrup Municipality, Denmark, 2600
        • Recruiting
        • Centre of Neuropsychiatric Depression Research
        • Contact:
        • Contact:
          • Iman B M E Ibrahim, MD, PhD-student
          • Phone Number: +4553466199 +4591175914
          • Email: IIBR0007@regionh.dk
      • Hilleroed, Denmark, 3400
        • Not yet recruiting
        • Mental Health Center North Zealand
        • Contact:
      • Hvidovre, Denmark, 2650
        • Not yet recruiting
        • Danish Research Centre for Magnetic Resonance
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • Age range between 18 and 95 years
  • In- or outpatients with a moderate to severe single episode or periodic MDD according to ICD-10, verified by a M.I.N.I. interview.
  • Major Depression Inventory (self-rapport) score higher than 25.
  • Lacking or insufficient effect of at least two drug trials from two distinct classes, e.g., SSRI, SNRI, TCA, or MAO-inhibitors, used in the current episode, with adequate dose and duration as judged by the investigator.
  • Duration of the current episode must be longer than 2 months but shorter than 4 years, as judged by the investigator.

Exclusion criteria:

  • History of neurologic disease affecting the brain, including dementia and epilepsy
  • Schizophrenia or any other psychotic disorder except for psychotic depression
  • Head trauma causing more than 5 minutes loss of consciousness
  • Suicidal or psychotic symptoms making the transport of participants hazardous
  • Any form of compulsory admission or treatment within the past three months
  • Treatment with ECT in the current depressive episode
  • Non-responders to TBS treatment within the current episode
  • Current harmful use or dependency of substances according to ICD-10 and interfering with outcome evaluation as judged by investigator's discretion.
  • High risk of non-adherence as judged by investigators discretion
  • Medical and psychiatric conditions interfering with study outcome and safety as judged by investigator's discretion.
  • Female participants of childbearing age must not be pregnant or breast feeding, and they must use contraception during the trial.
  • One of the prime contra-indications for MRI, including severe claustrophobia (see Appendix 08.05)
  • One of the prime contra-indications for TMS and persons with electrically, magnetically, or mechanically activated implants or with metal or magnetic pieces in their head (see Appendix 08.04)
  • Patients who do not wish to be informed about MRI or EEG findings, which may have clinical relevance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Real intermittent theta burst stimulatio (iTBS) of the dorsolateral prefrontal cortex (DLPFC)

Intermittent theta burst stimulation (iTBS) targeting the left dorsolateral prefrontal cortex (DLPFC) will be administered over five consecutive days.

On each intervention day, patients will undergo five high frequency iTBS sessions (each lasting approximately 10 minutes, excluding preparation) with about 50 minutes of rest between sessions. Each iTBS session delivers 1,800 pulses, resulting in a total of 25 sessions and 45,000 pulses over the course of a standard work week.

Active Comparator: Real intermittent theta burst stimulation (iTBS) of the left inferior parietal lobule (IPL)
Intermittent theta burst stimulation (iTBS) targeting the left inferior parietal lobule (IPL) will be administered over five consecutive days using the stimulation pattern described in the active DLPFC arm.
Sham Comparator: Sham Comparator: Sham stimulation to either left IPL (50%) or left DLPFC (50%)

Device: Sham stimulation of the left DLPFC or IPL will be administered using the same stimulation duration and repetition as the active iTBS.

To match the subjective experience of iTBS, the sham CoMPACT uses a dedicated (Active/Placebo) stimulation coil that has both active and sham functions, generating the same sound level regardless of the type of stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Hamilton Rating Scale for Depression-6 (HDS-6) Score
Time Frame: 1) Baseline T0: (1 (+1) week before intervention. 2) Before the first iTBS session on the first day of intervention week. 3) A day after end of intervention (+2 days). 4) Follow-up (T2): 4 weeks after end of intervention.

The HDS-6 total score reflects the severity of depression, ranging from 0 to 24, with higher scores indicating more severe symptoms.

0-6 = normal, 7-8= mild depression, 9-11 = moderate depression, 12-22 = severe to very severe depression.

A 3-point change is considered to be clinically significant, which is a very conservative criterion.

1) Baseline T0: (1 (+1) week before intervention. 2) Before the first iTBS session on the first day of intervention week. 3) A day after end of intervention (+2 days). 4) Follow-up (T2): 4 weeks after end of intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Hamilton Rating Scale for Depression-17 (HDS-17) Score
Time Frame: 1) Baseline T0: (1 (+1) week before intervention. 2) Before the first iTBS session on the first day of intervention week. 3) A day after end of intervention (+2 days) . 4) Follow-up (T2): 4 weeks after end of intervention.

The HDS-17 score ranges from 0 to 52, with higher scores reflecting greater depression severity.

0-7: Normal 8-13: Mild depression 14-18: Moderate depression 19-22: Severe depression

≥23: Very severe depression

1) Baseline T0: (1 (+1) week before intervention. 2) Before the first iTBS session on the first day of intervention week. 3) A day after end of intervention (+2 days) . 4) Follow-up (T2): 4 weeks after end of intervention.
Visual analogue mood scale (VAMS)
Time Frame: 1) Baseline T0: (1 (+1) week before intervention. 2) On every day of intervention. 3) Postintervention (T1): 3 (+/-2 ) days after end of intervention. 4) Follow-up (T2): 4 weeks after end of intervention.
Scale rating mood 1-10. Higher score indicate better mood.
1) Baseline T0: (1 (+1) week before intervention. 2) On every day of intervention. 3) Postintervention (T1): 3 (+/-2 ) days after end of intervention. 4) Follow-up (T2): 4 weeks after end of intervention.
TMS Sensation Questionnaire (TMSens_Q)
Time Frame: Intervention week: before and after the first and last sessions on both days 1 and 5
TMSens_Q assesses and quantifies the sensation and discomfort related to transcranial magnetic stimulation.
Intervention week: before and after the first and last sessions on both days 1 and 5
Screening for Cognitive Impairment in Psychiatry (SCIP)
Time Frame: 1) Baseline T0: (1 (+1) week before intervention. 2) Postintervention (T1): 3 (+/-2 ) days after end of intervention. 3) Follow-up (T2): 4 weeks after end of intervention.
The SCIP score ranges from 0 to 75, with lower scores indicating greater cognitive deficits.
1) Baseline T0: (1 (+1) week before intervention. 2) Postintervention (T1): 3 (+/-2 ) days after end of intervention. 3) Follow-up (T2): 4 weeks after end of intervention.
Cognitive Complaints in Bipolar Disorder Rating Assessment (COBRA) score
Time Frame: 1) Baseline T0: (1 (+1) week before intervention. 2) Postintervention (T1): 3 (+/-2 ) days after end of intervention. 3) Follow-up (T2): 4 weeks after end of intervention.
COBRA uses a 4-point scale (no difficulty- severe difficulty). The score ia 0 to 36, with higher scores indicating greater cognitive difficulties.
1) Baseline T0: (1 (+1) week before intervention. 2) Postintervention (T1): 3 (+/-2 ) days after end of intervention. 3) Follow-up (T2): 4 weeks after end of intervention.
Aarhus Side effect Assessment Questionnaire (ASAQ)
Time Frame: Baseline T0: (1 (+1) week before intervention. Postintervention (T1): 3 (+/-2 ) days after end of intervention. Follow-up (T2) 4 weeks after end of intervention.
ASAQ uses a 5-point scale (not at all to very much). The score is from 0 to 27. higher scores indicate greater presence of side effects.
Baseline T0: (1 (+1) week before intervention. Postintervention (T1): 3 (+/-2 ) days after end of intervention. Follow-up (T2) 4 weeks after end of intervention.
Young Mania Rating scale (YMRS)
Time Frame: Intervention week: before the first session on Day 1 and at the end of each intervention day.

The Young Mania Rating Scale (YMRS) is used to assess the potential risk of transcranial magnetic stimulation (TMS) inducing mania. It ranges from 0 to 60, with higher scores indicating more severe symptoms.

0-12: No significant mania 13-19: Mild mania 20-25: Moderate mania

≥26: Severe mania

Intervention week: before the first session on Day 1 and at the end of each intervention day.
The Stroop Color and Word Test (SCWT)
Time Frame: 1) Baseline T0: (1 (+1) week before intervention. 2) Postintervention (T1): 3 (+/-2 ) days after end of intervention. 3) Follow-up (T2): 4 weeks after end of intervention.
SCWT uses a 4 point scale (no difficulty to severe difficulty). Fewer errors and faster completion indicate better cognitive control and executive functioning.
1) Baseline T0: (1 (+1) week before intervention. 2) Postintervention (T1): 3 (+/-2 ) days after end of intervention. 3) Follow-up (T2): 4 weeks after end of intervention.
Trail Making Test A & B (TMT)
Time Frame: 1) Baseline T0: (1 (+1) week before intervention. 2) On the end of day 1 of intervention week. 3) Postintervention (T1): 3 (+/-2 ) days after end of intervention. 4) Follow-up (T2): 4 weeks after end of intervention.
TMT-A tests the times to connect all number in correct order. TMT-B tests the total time to alternate between numbers and letters. Fewer errors and faster completion indicate better cognitive control and executive functioning.
1) Baseline T0: (1 (+1) week before intervention. 2) On the end of day 1 of intervention week. 3) Postintervention (T1): 3 (+/-2 ) days after end of intervention. 4) Follow-up (T2): 4 weeks after end of intervention.
Grooved Pegboard Test (GPT)
Time Frame: 1) Baseline T0: (1 (+1) week before intervention. 2) On the end of day 1 of intervention week. 3) Postintervention (T1): 3 (+/-2 ) days after end of intervention. 4) Follow-up (T2): 4 weeks after end of intervention.
Grooved Pegboard Test (GPT). Fewer errors and faster completion indicate better motor skills.
1) Baseline T0: (1 (+1) week before intervention. 2) On the end of day 1 of intervention week. 3) Postintervention (T1): 3 (+/-2 ) days after end of intervention. 4) Follow-up (T2): 4 weeks after end of intervention.
Treatment Expectation Questionnaire (TEX-Q)
Time Frame: Baseline T0: (1 (+1) week before intervention.
Question about the patient's expectations for the treatment effect.
Baseline T0: (1 (+1) week before intervention.
Change in the WHO-5 Well-being Index (WHO-5) score
Time Frame: 1) Baseline T0: (1 (+1) week before intervention. 2) Postintervention (T1): 3 (+/-2 ) days after end of intervention. 3) Follow-up (T2): 4 weeks after end of intervention.

The World Health Organization Five Well-being Index (WHO-5) score measures overall well-being on a scale of 0 to 100, with higher scores indicating better well-being.

Score Interpretation:

0-28: Poor well-being, possible clinical depression 29-50: Low mood or well-being 51-100: Good well-being

1) Baseline T0: (1 (+1) week before intervention. 2) Postintervention (T1): 3 (+/-2 ) days after end of intervention. 3) Follow-up (T2): 4 weeks after end of intervention.
Change Snaith-Hamilton Pleasure Scale (SHAPS) score
Time Frame: 1) Baseline T0: (1 (+1) week before intervention. 2) Postintervention (T1): 3 (+/-2 ) days after end of intervention. 3) Follow-up (T2): 4 weeks after end of intervention.
SHAPS measure anhedonia. The score ranges from 0 to 14, with higher scores reflecting greater levels of anhedonia
1) Baseline T0: (1 (+1) week before intervention. 2) Postintervention (T1): 3 (+/-2 ) days after end of intervention. 3) Follow-up (T2): 4 weeks after end of intervention.
Change in Overall Anxiety Severity and Impairment Scale (OASIS) score
Time Frame: 1) Baseline T0: (1 (+1) week before intervention. 2) Postintervention (T1): 3 (+/-2 ) days after end of intervention. 3) Follow-up (T2): 4 weeks after end of intervention.
OASIS The score is between 0 and 20. Higher scores indicates greater levels of anxiety and impairment.
1) Baseline T0: (1 (+1) week before intervention. 2) Postintervention (T1): 3 (+/-2 ) days after end of intervention. 3) Follow-up (T2): 4 weeks after end of intervention.
Change in functionality Assessment Short Test (FAST) score
Time Frame: 1) Baseline T0: (1 (+1) week before intervention. 2) Postintervention (T1): 3 (+/-2 ) days after end of intervention. 3) Follow-up (T2): 4 weeks after end of intervention.
FAST FAST assesses functional impairment. The total score range is 0 to 72. Higher scores indicate greater functional impairment.
1) Baseline T0: (1 (+1) week before intervention. 2) Postintervention (T1): 3 (+/-2 ) days after end of intervention. 3) Follow-up (T2): 4 weeks after end of intervention.
Change in Pittsburgh Sleep Quality Index (PSQI) score
Time Frame: Baseline T0: (1 (+1) week before intervention., Postintervention (T1): 3 (+/-2 ) days after end of intervention. Follow-up (T2): 4 weeks after end of intervention.
PSQI assesses sleep quality. The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality.
Baseline T0: (1 (+1) week before intervention., Postintervention (T1): 3 (+/-2 ) days after end of intervention. Follow-up (T2): 4 weeks after end of intervention.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in magnetic resonance imaging (MRI) from baseline to postintervention
Time Frame: 1) Baseline T0: (1 (+1) week before intervention. 2) Postintervention (T1): 3 (+/-2 ) days after end of intervention.

Structural MRI (sMRI) gives high-resolution images of the brain anatomy and allows for accurate calculation of different volumes of the brain regions.

Diffusion MRI (dMRI) measures the regional diffusion properties of water and provides micro-structural information on the direction of fiber tracts and structural connectivity in relation to our stimulation targets.

Functional MRI (fMRI) can map the functional connectivity of the brain during resting periods and during performing reward related tasks.

1) Baseline T0: (1 (+1) week before intervention. 2) Postintervention (T1): 3 (+/-2 ) days after end of intervention.
Changes in Resting-State EEG Power Bands
Time Frame: Intervention week: Before and after first and last sessions on both days 1 and 5
EEG will be used to assess changes in cortical activity power induced by a single iTBS session, as well as the cumulative effects across an intervention day. The analysis will cover the entire frequency spectrum, with a particular focus on the theta and alpha bands. Additionally, alterations in both periodic and aperiodic components of the power spectrum will be studied.
Intervention week: Before and after first and last sessions on both days 1 and 5
Immediate changes in EEG power spectrum
Time Frame: Intervention week: During the first and last sessions on both days 1 and 5
EEG will be used to assess acute changes in cortical power spectrum between consecutive burst trains with a particular focus on the theta and alpha band. Additionally, alterations in both periodic and aperiodic components of the power spectrum will be studied.
Intervention week: During the first and last sessions on both days 1 and 5
Changes in EEG-based Connectivity
Time Frame: Intervention week. Before, during and after the first and last sessions both days 1 and 5
Exploratory analysis of potential alterations in connectivity within the related network during and after a single iTBS session, compared to baseline. In addition to the investigation of a single session, the cumulative effect of multiple sessions will also be explored.
Intervention week. Before, during and after the first and last sessions both days 1 and 5
Changes in TEPs ( transcranial evoked potentials)
Time Frame: Intervention week. Before and after first and last sessions on both days 1 and 5
TEP measurements (EEG response to single and multiple TMS pulses) will be conducted using active and sham TMS protocols. Changes in TEP components (peaks such as N45, P60, and N100) induced by a single intervention session or across multiple sessions will be studied.
Intervention week. Before and after first and last sessions on both days 1 and 5
Heart rate variability
Time Frame: Intervention week. During first and last sessions on both days 1 and 5
Electrocardiography (ECG) will measure changes in heart rate variability (HRV), specifically RR interval variability, during an iTBS session. This will serve as a heart-brain coupling index, which reflects target engagement by assessing autonomic nervous system activity in relation to neural activity.
Intervention week. During first and last sessions on both days 1 and 5
Patient guess regarding treatment
Time Frame: Postintervention (T1): 3 (+/-2 ) days after end of intervention.
Questionnaire assessing the patient's guess of whether they have received active or sham stimulation.
Postintervention (T1): 3 (+/-2 ) days after end of intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Hartwig Siebner, Professor, Danish Researach Centre for Magnetic Resonance
  • Principal Investigator: Poul Videbech, Professor, Center for Neuropsychiatric Depression Research, Mental health Center Glostrup

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2025

Primary Completion (Estimated)

January 31, 2028

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

January 16, 2025

First Submitted That Met QC Criteria

March 19, 2025

First Posted (Actual)

March 26, 2025

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 20, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • CoMPACT
  • 10.46540/3166-00150B (Other Grant/Funding Number: The Independent Research Fond Denmark)
  • Precision-BCT - 9068-00025A (Other Grant/Funding Number: Innovation Fund Denmark)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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