The BIomarker Guided (BIG) Study for Depression (BIG)

March 7, 2025 updated by: Laura Hack, Stanford University

Precision Mental Health: Evaluating Biotype-guided Interventions for Depression

Cognitive impairments contribute significantly to psychosocial dysfunction in major depressive disorder (MDD) and respond poorly to conventional antidepressants, yet selective treatments targeted to these impairments are lacking. Our previous research identified a distinct subgroup of depression called "cognitive biotype+" that comprises 27% of depressed patients and is characterized by pre-treatment global cognitive impairments and dysfunction in the cognitive control neural circuit. In this study, we evaluated the medication guanfacine immediate release (GIR), an alpha 2A receptor agonist, as a novel treatment for selectively improving cognitive control circuit function, performance on cognitive testing, and clinical measures the cognitive biotype+ subgroup.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The flow of procedures and study visits is as follows:

  1. Recruitment and screening: Participants experiencing depressive symptoms and not taking any psychiatric medications as determined by a 5 half-life wash out period will be recruited from the community, including students and employees at Stanford. Recruitment will come primarily from Facebook ads, which will use only IRB approved material. A flyer will also be physically posted on boards in public locations in order to include a variety of sources for the study.
  2. Individuals will need to participate in 3 screening visits in order to enroll in the study. During the first visit, participants will review informed consent, be administered a clinical interview, and be sent instructions for completing cognitive testing at home.
  3. If eligibility after this initial screening visit, the second visit will be a medical screen in order to ensure participants are safe to take GIR and will include standard blood tests, medical history, vitals, and a urine drug test.
  4. If the participant meets medical and cognitive criteria, functional magnetic resonance imaging (fMRI) scans will be undertaken at another study visit at The Stanford Center for Cognitive and Neurobiological Imaging (CNI). Using a participant's task-evoked activity in the dorsolateral prefrontal cortex (dLPFC) and performance on objective cognitive testing, we will apply thresholds using established healthy norms to select participants within the cognitive biotype+ group.
  5. Participants will receive GIR for a period of 8 weeks sent to their place of residence from Mariner pharmacy.
  6. Participants will be seen in-person or virtually by a study clinician at weeks 2, 4, 6, 8, and 10 and an appropriately trained clinical research coordinator at weeks 1, 3, 5, 7, and 9. All subjects will have an fMRI scan after 6-8 weeks of taking GIR. During in-person visits and virtual monitoring, we will assess participants for the following: changes to symptoms, function, and suicidality, adherence to GIR, changes to concomitant medication(s), adverse events (AEs), birth control usage compliance, likelihood of pregnancy (female participants of childbearing potential), and vital signs if appropriate.
  7. If participants wish to continue GIR and their psychiatrist or PCP is willing to prescribe this, they will continue with their current dose for weeks 9 and 10. If they prefer to stop taking GIR and/or they do not have a provider who is willing to continue GIR, the participant will be tapered off the medication.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Stanford Psychiatry

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18-69 years of age (inclusive)
  • Go-NoGo fMRI task-evoked dLPFC ≤ - 0.5 SD below the mean of normative sample
  • Behavioral cognitive control performance ≤ - 0.5 SD below the mean of normative sample on a Maze, Digit Span, and/or Verbal Interference (Stroop) task administered using WebNeuro
  • Score ≥ 14 on the 17-item Hamilton Depression Rating Scale-17 (HDRS-17)
  • Meets DSM-5 diagnostic criteria for current, past, or recurrent nonpsychotic major depressive disorder established by MINI Plus
  • Medication naïve to guanfacine
  • Fluent and literate in English, and show non-impaired intellectual abilities to ensure adequate comprehension of the task instructions
  • Written, informed consent
  • fMRI scanning eligibility, including no evidence of any form of metal embedded in the body (e.g., metal wires, nuts, bolts, screws, plates, sutures), as these produce artifacts when brain imaging. All potential subjects will need to successfully complete the screening forms at the Stanford Center for Cognitive and Neurobiological Imaging (CNI).

Exclusion Criteria:

  • Presence of suicidal ideations representing imminent risk, defined by a score of > 8 on the MINI-Plus, or by clinician judgement
  • Lifetime history of medical illness or injury that may compromise cognitive functioning or interfere with assessments as deemed by the study physician (such as neurological disorders such as seizures or stroke, Parkinson's disease, dementia, or traumatic brain injury)
  • Severe impediment to vision, hearing, and/or hand movement likely to interfere with ability to complete the assessments, or are unable and/or unlikely to follow the study protocols
  • Pregnant, breastfeeding or unwilling or unable to use adequate birth control throughout the study
  • Loss of consciousness for > 10 minutes during lifetime
  • Any contraindication to being scanned in the 3.0T scanner at the CNI such as having a pacemaker or implanted device that has not been cleared for scanning at 3.0 Tesla
  • Previous or current DSM-5 bipolar disorder (I, II, not otherwise specified) or psychosis
  • Meets criteria for DSM-5 alcohol or substance use disorder within the last 12 months
  • Meets criteria for current DSM-5 PTSD, OCD, or eating disorder
  • Concurrent participation in other intervention or treatment studies
  • Current use of psychotropic medications. If their usual treating physician is supportive, participants who are currently on psychotropics that can be safely tapered may be tapered off to participate but participant must wait 5 half-lives prior to first scan
  • Current use of a strong CYP3A4 inhibitor or inducer (macrolide/ketolide antibiotics [clarithromycin, telithromycin], azole antifungals [itraconazole, ketoconazole, posaconazole, voriconazole], protease inhibitors [atazanavir, darunavir, indinavir, lopinavir, nelfinavir, ombitasvir, paritaprevir, ritonavir, saquinavir], ceritinib, cobicistat, and idealisib), or inducer (apalutamide, carbamazepine, enzalutamide, fosphenytoin, lumacaftor, lumacaftor-ivacaftor, mitotane, phenobarbital, phenytoin, primidone, rifampin)
  • Hypotension as defined by SBP ≤ 90 and/or DBP ≤60 on 2 of 3 separate measurements at least 5 minutes apart, bradycardia as defined by HR ≤55 on 2 of 3 separate measurements at least 5 minutes apart
  • General medical condition, disease, or neurological disorder as reported by participant or found on in-person screenings that is deemed by the study physicians to be unsafe for GIR treatment, including kidney or liver impairment that is deemed to be unsafe, EKG abnormalities that are deemed to be unsafe, or cardiovascular disease deemed to be unsafe.
  • History of sudden cardiac death in first degree relatives
  • Positive drug screen for any substance deemed by the study physician to be unsafe for use with GIR in combination with other information obtained during screening

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Guanfacine Treatment Group
Participants will be prescribed tabs containing guanfacine immediate release (GIR) to be taken for 8 weeks and will be monitored by one of the study psychiatrists/nurse practitioners. Subjects will start with 0.5mg GIR nightly and increase by 0.5mg every 3 days with a goal dose of 2mg.
Drug: Guanfacine Tablets
Guanfacine immediate release, sold under the brand name Tenex among others, is a medication used to treat high blood pressure and off-label to treat attention deficit hyperactivity disorder (ADHD). It is taken by mouth and will be compounded by a pharmacy to the required doses used in this study.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Cognitive Control Circuit Function Z-score
Time Frame: pre-treatment, 8 weeks
During functional magnetic resonance imaging (fMRI), the cognitive control circuit was engaged by a Go-NoGo task, and circuit activation was quantified by blood flow in three regions of interest in the brain (dorsal anterior cingulate cortex [dACC], left dorsolateral prefrontal cortex [dLPFC], and right dLPFC) and the extent of functional connectivity between them. Task-evoked activation and connectivity are expressed as Z-scores, which represent the number of standard deviations the observed value is from the mean of a healthy reference dataset (population mean = 0). There is no fixed minimum or maximum for Z-scores. Standard deviations above the mean (a positive Z-score) indicate that the observed activation or connectivity is higher than the mean of the healthy reference dataset, while standard deviations below the mean (a negative Z-score) indicate it is lower. A negative Z-score indicates a worse outcome. For this study, a Z-score of <= -0.5 indicates poor cognitive control.
pre-treatment, 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With a Score of ≤7 on the 17-item Hamilton Depression Rating Scale (HDRS-17) at Week 8 as a Measure of Depression Remission.
Time Frame: 8 weeks
Possible HDRS-17 scores range from 0 (no depression) to 52 (severe depression).
8 weeks
Number of Participants With a Score ≤5 on the Quick Inventory of Depressive Symptoms-Self Report (QIDS-SR) at Week 8 as a Measure of Depression Remission.
Time Frame: 8 weeks
Possible QIDS-SR scores range from 0 (no depression) to 27 (severe depression).
8 weeks
Number of Participants With a ≥50% Reduction on the 17-item Hamilton Depression Rating Scale (HDRS-17) as a Measure of Depression Response.
Time Frame: pre-treatment, 8 weeks
Possible HDRS-17 scores range from 0 (no depression) to 52 (severe depression).
pre-treatment, 8 weeks
Number of Participants With a ≥50% Reduction From Baseline on the Quick Inventory of Depressive Symptoms-Self Report (QIDS-SR) as a Measure of Depression Response.
Time Frame: pre-treatment, 8 weeks
Possible QIDS-SR scores range from 0 (no depression) to 27 (severe depression).
pre-treatment, 8 weeks
Change in Depression Scores on the 17-item Hamilton Depression Rating Scale (HDRS-17)
Time Frame: baseline, 2 weeks, 8 weeks
Possible HDRS-17 scores range from 0 (no depression) to 52 (severe depression).
baseline, 2 weeks, 8 weeks
Change in Depression Scores on the Quick Inventory of Depressive Symptoms-Self Report (QIDS-SR)
Time Frame: pre-treatment, 2 weeks, 4 weeks, 6 weeks, 8 weeks
Possible QIDS-SR scores range from 0 (no depression) to 27 (severe depression).
pre-treatment, 2 weeks, 4 weeks, 6 weeks, 8 weeks
Change in Cognitive Control Behavioral Performance Z-score
Time Frame: pre-treatment, 8 weeks
Cognitive control behavioral performance was assessed using the WebNeuro computerized battery measuring cognitive control. Test performance is expressed as a composite Z-score, representing deviations from the mean of a healthy reference dataset (population mean = 0). Composite Z-scores were calculated by averaging: Maze (trials completed, completion and path learning time, errors), Digit Span (recall span, correct trials), Verbal Interference (total errors, reaction time), and Switching of Attention (completion time, connection time, errors). For GoNoGo, only reaction times were used as data was collected in-scanner, and data for this measure was normalized to the group. Extreme scores were winsorized to a threshold of 5 standard deviations. Z-scores have no fixed range; positive scores indicate better performance, negative scores indicate worse performance. For this study, a Z-score of <= -0.5 indicates poor cognitive control performance.
pre-treatment, 8 weeks
Change in the Satisfaction With Life Scale (SWLS) Score
Time Frame: pre-treatment, 2 weeks, 8 weeks
Possible scores on the SWLS range from 5 (extreme dissatisfaction) to 35 (extreme satisfaction).
pre-treatment, 2 weeks, 8 weeks
Change in the World Health Organization Quality of Life - Brief (WHOQOL-BREF) Scale Scale Score
Time Frame: pre-treatment, 2 weeks, 8 weeks
Scores on the WHOQOL-BREF are transformed to a scale of 0 (poor quality of life) to 100 (excellent quality of life).
pre-treatment, 2 weeks, 8 weeks
Change in the Columbia-Suicide Severity Rating Scale (C-SSRS) Ideation Score
Time Frame: pre-treatment, 8 weeks
Possible scores on the C-SSRS ideation range from 0 (no suicidal ideation) to 5 (high suicidal ideation).
pre-treatment, 8 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Barratt Impulsiveness Scale (BIS) score
Time Frame: 4 weeks, 6 weeks
A questionnaire designed to assess the personality/behavioural construct of impulsiveness--total score and attention items only.
4 weeks, 6 weeks
Change in Hamilton Depression Rating Scale 17-item (HAMD) score
Time Frame: 4 weeks, 6 weeks
Clinician rated 17-item overall depression severity score.
4 weeks, 6 weeks
Change in Clinical Global Impression of Improvement (CGI-I)
Time Frame: 4 weeks, 6 weeks
Clinician rated global measure of the degree of improvement from initial assessment in overall illness severity.
4 weeks, 6 weeks
Change in Clinical Global Impression of Severity (CGI-S)
Time Frame: 4 weeks, 6 weeks
Clinician rated global measure of subject overall illness severity.
4 weeks, 6 weeks
Change in Quick Inventory of Depressive Symptoms-Self Report (QIDS-SR)
Time Frame: 4 weeks, 6 weeks
A 16-item self-report measure that assesses the severity of depression symptoms in the past week on a 4-point scale ranging from 0 to 3.
4 weeks, 6 weeks
Change in Columbia-Suicide Severity Rating Scale (C-SSRS)
Time Frame: 4 weeks, 6 weeks
A scale designed to quantify the severity of suicidal ideation and behavior.
4 weeks, 6 weeks
Change in World Health Organization Quality of Life (WHOQoL) scale
Time Frame: 4 weeks, 6 weeks

A 26-item questionnaire that measures quality of life out of 100 in the following domains:

physical health, psychological health, social relationships, and environment.
4 weeks, 6 weeks
Change in Depression, Anxiety, and Stress Scale (DASS)
Time Frame: 4 weeks, 6 weeks
A 42-item self-report scale that assesses symptoms of depression/anhedonia, anxious arousal and generalized anxiety (stress) that are not tied to a particular diagnosis.
4 weeks, 6 weeks
Change in Emotion Regulation Questionnaire (ERQ)
Time Frame: 4 weeks, 6 weeks
A 10-item self-report questionnaire designed to assess individual differences in the habitual use of two emotion regulation strategies: cognitive reappraisal and expressive suppression.
4 weeks, 6 weeks
Change in Beck Depression Inventory (BDI)
Time Frame: 4 weeks, 6 weeks
A 21-item, self-report rating inventory that measures symptoms of depression such as hopelessness and irritability, cognitions such as guilt or feelings of being punished, as well as physical symptoms such as fatigue, weight loss, and lack of interest in sex.
4 weeks, 6 weeks
Change in Beck Anxiety Inventory (BAI)
Time Frame: 4 weeks, 6 weeks
A 21-item self-report inventory for measuring the severity of common symptoms of anxiety that the participant has had during the past week, such as numbness and tingling, sweating not due to heat, and fear of the worst happening.
4 weeks, 6 weeks
Change in Penn State Worry Questionnaire (PSWQ)
Time Frame: 4 weeks, 6 weeks
A 16-item self-report questionnaire that assesses items such as "my worries overwhelm me" and is rated on a likert scale, with scores ranging from 1 to 80.
4 weeks, 6 weeks
Change in Mood and Anxiety Symptom Questionnaire (MASQ)
Time Frame: 4 weeks, 6 weeks
A 90-item questionnaire based on the tripartite model of affective disorder which encompasses constructs of anhedonia, anxious arousal and generalized distress, equivalent to the DASS, and which has also been used in healthy and patient groups.
4 weeks, 6 weeks
Change in Sheehan Disability Scale (SDS)
Time Frame: 4 weeks, 6 weeks
A 3-item self-report questionnaire that measures functional capacity in work/school, social life, and family life on a scale of 0-10.
4 weeks, 6 weeks
Change in PTSD Checklist - Civilian Version (PLC-C)
Time Frame: 4 weeks, 6 weeks
A 17-item self-report scale that measures symptoms of PTSD in the past month on a 5-point scale ranging from 1 to 5.
4 weeks, 6 weeks
Change in Ruminative Responses Scale (RRS)
Time Frame: 4 weeks, 6 weeks
A 22-item self-report questionnaire that assesses two aspects of rumination; brooding and reflecting pondering. It is scored on a 4-point scale ranging from 1 to 4.
4 weeks, 6 weeks
Change in Snaith-Hamilton Pleasure Scale (SHAPS)
Time Frame: 4 weeks, 6 weeks
A 14-item self-report measure to determine anhedonia levels. It is scored on a 4-point scale of 1 (strongly disagree, disagree) and 0 (strongly agree, agree).
4 weeks, 6 weeks
Change in Fagerstrom Nicotine Dependence Survey (FNDS)
Time Frame: 4 weeks, 6 weeks
A short 6-item instrument used for assessing the intensity of physical nicotine addiction.
4 weeks, 6 weeks
Change in Satisfaction With Life Scale (SWLS)
Time Frame: 4 weeks, 6 weeks
A short, 5-item instrument designed to measure global cognitive judgments of satisfaction with one's life.
4 weeks, 6 weeks
Change in Health Productivity Questionnaire (HPQ)
Time Frame: 4 weeks, 6 weeks
This is a 14-item scale that assesses productivity at work, and relative and absolute levels of absenteeism from work as well as presenteeism (being at work, but unproductive due to the effects of anxiety and depressive symptoms).
4 weeks, 6 weeks
Change in Brief COPE
Time Frame: 4 weeks, 6 weeks
A multidimensional coping inventory to assess the different ways in which people respond to stress.
4 weeks, 6 weeks
Change in NIDA-Modified Alcohol, Smoking, and Substance Involvement Screening Test (NM-ASSIST)
Time Frame: 4 weeks, 6 weeks
A 15-item measure adapted from the World Health Organization (WHO) Alcohol, Smoking and Substance Involvement Screening Test, used to assess prescription medicine and illicit substance use in adults age 18 and older.
4 weeks, 6 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stanford University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Leanne M Williams, PhD, Stanford University
  • Principal Investigator: Laura M Hack, MD, PhD, Stanford University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 14, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 17, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 12, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 26, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 29, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 49147

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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