Major Depressive DisorderNCT02634177
Genecept Assay™ vs. Treatment-as-Usual to Evaluate Efficacy of Assay-Guided Treatment in Adults With MDD
A study testing Assay-guided treatment (AGT) and Treatment-as-usual (TAU) in people with Major Depressive Disorder, run by Genomind, LLC at 23 sites in United States.
Trial summary
In this randomized clinical trial, subjects will be assigned to either an assay-guided treatment condition (AGT) or a treatment-as-usual condition (TAU). All subjects will provide a DNA sample at the Screening Visit for the Genecept Assay ™. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Assay-guided treatment (AGT) and Treatment-as-usual (TAU)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 305 participants
- Where
- 23 sitesUnited States
- Study dates
- Jan 2016to 25 Jul 2017
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years; Sub-Group Age =/> 65 years
- Ability to understand and provide informed consent
- Ability to understand, read and speak English
- Primary diagnosis of Major Depressive Disorder (without psychosis) based on DSM-5 criteria and MINI 7.0
- SIGH-D-17 score >18 (i.e., moderate depression) at Screening and Baseline
- Failure of at least 1 prior adequate trial of standard antidepressant in the current major depressive episode (using ATRQ criteria - i.e., 6 weeks at adequate dose) due to inefficacy, side effects or intolerability
- Subject is willing to follow study instructions, complete study assessments and likely to complete all required visits
Who cannot join
- Severe personality traits (based on DSM-5 criteria) that in the opinion of the investigator may interfere with the participation in the study or the evaluation of efficacy and safety and all diagnosed Personality Disorders
- Current DSM-5 diagnosis of Neurocognitive Disorders, Schizophrenia Spectrum (lifetime diagnosis) and other Psychotic Disorders, Bipolar and Related disorders (lifetime diagnosis*), Trauma and Stress related Disorders, Obsessive Compulsive Disorder and Related Disorders. Other DSM-5 disorders that in the opinion of the investigator may interfere with the participation in the study or the evaluation of efficacy and safety.
- DSM-5 diagnosis of Substance Related and Addictive Disorders diagnosed in the last 12 months (other than tobacco and caffeine)
- History of Suicidal Behavior within 12 months of screening or presence of Active Suicidal Ideation with Intent in the past 12 months (Items 4 or 5) at Screening or Baseline, as determined by the Columbia Suicide Severity Rating Scale (C-SSRS), or subject is considered to be an acute suicide risk in the clinical judgment of the investigator
- Previous homicidal behavior or acute homicidal risk at Screening or Baseline, in the clinical judgment of the investigator
- Four (4) or more failed pharmacologic interventions for depression in the current major depressive episode (One of the four failed interventions must meet ATRQ criteria - i.e., 6 weeks at adequate dose).
Show all 16Show fewer
- Subjects who are not willing to take psychotropic medications for treatment of MDD.
- Electroconvulsive therapy (ECT) or transcranial magnetic stimulation therapy (TMS) started within 90 days of screening or planned during the study.
- Subjects with a vagus nerve or deep brain stimulator are prohibited from the trial.
- Psychotherapy including cognitive behavioral therapy (CBT), or dialectical behavioral therapy (DBT) started within 90 days of screening or planned during the study.
- Unstable or active medical condition(s) which in the opinion of the investigator would jeopardize the subject's safety or interfere with participation of the study or confound evaluation of efficacy or safety.
- Current diagnosis of unstable hypothyroidism.
- Females who are pregnant, nursing, or planning a pregnancy during the study or believe they may be pregnant at Screening or Baseline.
- Participation in another investigative trial within 30 days of screening
- Subject previously treated with the use of a similar psychotropic genetic testing assay.
- Subject tests positive for illicit drug use on the urine drug screen (UDS) at the screen visit (including Marijuana where legal).
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
BioBehavioral Research of Austin, PC
Austin, Texas, 78759
University of Alabama - Birmingham
Birmingham, Alabama, 35294
Boston Clinical Trials
Boston, Massachusetts, 02131
Florida Clinical Research Center, LLC - Bradenton
Bradenton, Florida, 34201
University of Virginia Center for Psychiatric Research
Charlottesville, Virginia, 22903
Chicago Research Center, Inc.
Chicago, Illinois, 60634
Midwest Clinical Research Center
Dayton, Ohio, 45417
Collaborative Neuroscience Network, Inc. - Garden Grove
Garden Grove, California, 92845
Clinical Neuroscience Solutions Inc. - Jacksonville
Jacksonville, Florida, 32256
Premier Psychiatric Research Institute, LLC
Lincoln, Nebraska, 68526
Pacific Institute of Medical Research
Los Angeles, California, 90024
Florida Clinical Research Center, LLC - Maitland
Maitland, Florida, 32751
Clinical Neuroscience Solutions Inc. - Memphis
Memphis, Tennessee, 38119
Pacific Research Partners, LLC
Oakland, California, 94612
IPS Research Company
Oklahoma City, Oklahoma, 73103
Clinical Neuroscience Solutions Inc. - Orlando
Orlando, Florida, 32801
Thomas Jefferson University Mood Disorder Program
Philadelphia, Pennsylvania, 19107
Noesis Pharma
Phoenix, Arizona, 85032
Richard H Weisler MD, PA and Associates
Raleigh, North Carolina, 27609
Artemis Institute for Clinical Research
San Diego, California, 92103
Woodland Research Northwest
Springdale, Arkansas, 72764
Collaborative Neuroscience Network, Inc. - Torrance
Torrance, California, 90502
Pacific Clinical Research Medical Group
Upland, California, 91786
About this study
Official title: An 8-Week Prospective Randomized, Controlled, Double-Blind Trial of the Genecept Assay ™ vs. Treatment-as-Usual to Evaluate Efficacy of Assay-Guided Treatment in Adults With Major Depressive Disorder (MDD)
In this randomized clinical trial, subjects will be assigned to either an assay-guided treatment condition (AGT) or a treatment-as-usual condition (TAU). All subjects will provide a DNA sample at the Screening Visit for the Genecept Assay ™. In the AGT condition, assay results will be provided to the treating investigator, who will use the results to guide antidepressant pharmacotherapy. In the TAU condition, the investigator will treat the subjects without the knowledge of the pharmacogenetic testing results. Assay results for all subjects will be provided to the investigator once all Week 8 visit procedures have been completed. Raters of the primary endpoint assessment and subjects will remain blinded to treatment assignment.
Read the detailed description
This study compares efficacy and safety outcomes in Major Depressive Disorder (MDD) adult patients randomized to assay-guided treatment (AGT) or treatment-as-usual (TAU). The treatment duration will be 8-weeks. Subjects will be assessed at visits at Week 2, 4, 6 and 8. Approximately 300 subjects will be randomized 1:1 to the two treatment group (AGT and TAU). This is a multi-center trial, with approximately 25 sites in the US. Randomization will be by IWRS. The treating investigator will be unblinded to treatment assignment (necessarily). Other site staff, sponsor staff (including site monitors) and all others will be blinded to treatment assignment for the duration of the subject's participation in the study. The (blinded) rater for the primary endpoint, the SIGH-D-17 Hamilton Depression Scale, will have no other contact with the subject such as collection of screening data, follow-up assessments, documentation of adverse events, etc. Blinded raters will not discuss subjects with other study staff.
After recruitment for main study is completed, an additional 70 subjects , age 65 years and older will be randomized to the Exploratory Elderly MDD Study. This follow-on sub-study will apply all procedures of the main study to this elderly population subset.
- Conditions
- Major Depressive Disorder
- Being tested
- Assay-guided treatment (AGT), Treatment-as-usual (TAU)
- Keywords
- Genotyping, Genecept Assay™
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assay-guided treatment (AGT)Genetic
Also called Genecept Assay™
The assay provides information to guide pharmacotherapeutic decisions personalized to a patient's genetic profile, to maximize improvement in symptomatology and minimize treatment failure and treatment intolerability.
Subjects are treated-as-usual without the aid of the assay.
| Study group | Role | What they receive |
|---|---|---|
| Assay-guided treatment (AGT) | Active comparator | Assay results will be provided to the treating investigator, who will use the results to guide pharmacotherapy of the subject's MDD treatment. Receives: Genetic: Assay-guided treatment (AGT) |
| Treatment-as-usual (TAU) | Placebo comparator | The treating investigator will treat subjects of the TAU group without the knowledge of the pharmacogenetic testing results. Receives: Other: Treatment-as-usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in SIGH-D-17 Score at 8 Weeks.
SIGH-D-17: 17-item rater-administered Structured Interview Guide of the Hamilton Depression Rating Scale
Scoring is based on the 17-item scale and scores range from 0 minimum to 52 maximum. Scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression; the maximum score being 52 on the 17-point scale.
Measured: Baseline to 8 Weeks
Secondary outcomes (8)
Mean Change From Baseline in QIDS-SR16 Score at 8 Weeks.
QIDS-SR16: 16-item Quick Inventory of Depressive Symptomatology Self-Report
QIDS-SR16 ranges from a score of 0 minimum to 27 maximum. In terms of severity of depression, Scores of 0 to 5 reflect "none", scores of 6 to 15 reflect "mild", scores of 7-20 reflect "moderate and scores of 21 to 27 reflect "severe" depression.
Measured: Baseline to 8 Weeks
Percentage of Treatment Responders at Week 8 Based on ≥ 50% Reduction of SIGH-D-17 Score From Baseline.
SIGH-D-17: 17-item rater-administered Structured Interview Guide of the Hamilton Depression Rating Scale
Measured: Baseline to 8 Weeks
Percentage of Treatment Responders at Week 8 Based on ≥ 50% Reduction of QIDS-SR16 Score From Baseline.
QIDS-SR16: 16-item Quick Inventory of Depressive Symptomatology Self-Report
QIDS-SR16 ranges from a score of 0 minimum to 27 maximum. In terms of severity of depression, Scores of 0 to 5 reflect "none", scores of 6 to 15 reflect "mild", scores of 7-20 reflect "moderate and scores of 21 to 27 reflect "severe" depression.
Measured: Baseline to 8 Weeks
Percentage of Treatment Responders at Week 8 Based on ≤ 3 Score on the CGI-I.
CGI-I: Clinical Global Impression Improvement scale; a clinician-rated scale that measures the improvement or worsening of a patient's symptoms
The CGI-I is rated on a 7-point scale, with the improvement in severity of illness scale using a range of responses from 1 (Very much improved) through to 7 (Very much worse).
A score of 0 indicates Patient was not able to be assessed
Measured: Baseline to 8 Weeks
Percentage of Remitters at Week 8 Based on ≤ 7 Score on the SIGH-D-17.
SIGH-D-17: 17-item rater-administered Structured Interview Guide of the Hamilton Depression Rating Scale
Scoring is based on the 17-item scale and scores range from 0 minimum to 52 maximum. Scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression; the maximum score being 52 on the 17-point scale.
Measured: Baseline to 8 Weeks
Percentage of Remitters at Week 8 Based on ≤ 5 Score on the QIDS-SR16.
QIDS-SR16: 16-item Quick Inventory of Depressive Symptomatology Self-Report
QIDS-SR16 ranges from a score of 0 minimum to 27 maximum. In terms of severity of depression, Scores of 0 to 5 reflect "none", scores of 6 to 15 reflect "mild", scores of 7-20 reflect "moderate and scores of 21 to 27 reflect "severe" depression.
Measured: Baseline to 8 Weeks
Safety Outcomes Based on Frequency, Intensity and Burden of Side Effects Rating (FIBSER).
A 3-question patient-rated scale for assessing frequency, intensity, and burden of medication side effects for patients receiving treatment for depression.
The Frequency, Intensity, and Burden of Side Effects-Rating (FIBSER) questionnaire uses 3 questions with a 6-point Likert measurement scale.
A score of 0-2 on question 3 (burden of side effects) represents an acceptable low side-effect burden usually requiring no treatment adjustment. A score of 3 or 4 indicates moderate side-effect burden that should be evaluated further (eg, timing related to dose change, patient concerns, etc), and an adjustment such as a dose decrease considered. A score of 5 or 6 indicates a high burden warranting a change such as dose decrease, switching, or direct treatment of the side effect(s).
Measured: Baseline to 8 Weeks
Safety Outcomes Based on Frequency and Severity of Reported Adverse Events.
Untoward medical occurrence in a subject administered a pharmaceutical product which does not necessarily have to have a causal relationship with treatment.
As based on FIBSER
The Frequency, Intensity, and Burden of Side Effects-Rating (FIBSER) questionnaire uses 3 questions with a 6-point Likert measurement scale.
A score of 0-2 on question 3 (burden of side effects) represents an acceptable low side-effect burden usually requiring no treatment adjustment. A score of 3 or 4 indicates moderate side-effect burden that should be evaluated further (eg, timing related to dose change, patient concerns, etc), and an adjustment such as a dose decrease considered. A score of 5 or 6 indicates a high burden warranting a change such as dose decrease, switching, or direct treatment of the side effect(s). Scores refer to intensity, frequency and interference.
Measured: Screening to 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study startJan 2016
- Primary completion25 Jul 2017
- Study completion25 Jul 2017
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 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genomind, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Responsible party
- Sponsor
- Investigators
- David Krause, MD, Study chair, Genomind CMO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02634177
- Sponsor's protocol ID
- GNM-PROT MDD-01
- Status last verified
- Oct 2019
- First submitted
- 14 Dec 2015
- Last updated
- 28 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An 8-Week Prospective Randomized, Controlled, Double-Blind Trial of the Genecept Assay ™ vs. Treatment-as-Usual to Evaluate Efficacy of Assay-Guided Treatment in Adults With Major Depressive Disorder (MDD)
- ClinicalTrials.gov ID
- NCT02634177
- Acronym / sponsor ID
- GNM-PROT MDD-01
- Conditions
- Major Depressive Disorder
- Keywords
- Genotyping, Genecept Assay™
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- Genomind, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Study start
- Jan 2016
- Primary completion
- 25 Jul 2017 (actual)
- Study completion
- 25 Jul 2017 (actual)
- First posted
- 17 Dec 2015 (estimated)
- Results
- Posted 28 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this randomized clinical trial, subjects will be assigned to either an assay-guided treatment condition (AGT) or a treatment-as-usual condition (TAU). All subjects will provide a DNA sample at the Screening Visit for the Genecept Assay ™. In the AGT condition, assay results will be provided to the treating investigator, who will use the results to guide antidepressant pharmacotherapy. In the TAU condition, the investigator will treat the subjects without the knowledge of the pharmacogenetic testing results. Assay results for all subjects will be provided to the investigator once all Week 8 visit procedures have been completed. Raters of the primary endpoint assessment and subjects will remain blinded to treatment assignment.
Detailed description
This study compares efficacy and safety outcomes in Major Depressive Disorder (MDD) adult patients randomized to assay-guided treatment (AGT) or treatment-as-usual (TAU). The treatment duration will be 8-weeks. Subjects will be assessed at visits at Week 2, 4, 6 and 8. Approximately 300 subjects will be randomized 1:1 to the two treatment group (AGT and TAU). This is a multi-center trial, with approximately 25 sites in the US. Randomization will be by IWRS. The treating investigator will be unblinded to treatment assignment (necessarily). Other site staff, sponsor staff (including site monitors) and all others will be blinded to treatment assignment for the duration of the subject's participation in the study. The (blinded) rater for the primary endpoint, the SIGH-D-17 Hamilton Depression Scale, will have no other contact with the subject such as collection of screening data, follow-up assessments, documentation of adverse events, etc. Blinded raters will not discuss subjects with other study staff.
After recruitment for main study is completed, an additional 70 subjects , age 65 years and older will be randomized to the Exploratory Elderly MDD Study. This follow-on sub-study will apply all procedures of the main study to this elderly population subset.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Assay-guided treatment (AGT) | Active comparator | Genetic: Assay-guided treatment (AGT)Assay results will be provided to the treating investigator, who will use the results to guide pharmacotherapy of the subject's MDD treatment. |
| Treatment-as-usual (TAU) | Placebo comparator | Other: Treatment-as-usual (TAU)The treating investigator will treat subjects of the TAU group without the knowledge of the pharmacogenetic testing results. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18-75 years; Sub-Group Age =/> 65 years
- Ability to understand and provide informed consent
- Ability to understand, read and speak English
- Primary diagnosis of Major Depressive Disorder (without psychosis) based on DSM-5 criteria and MINI 7.0
- SIGH-D-17 score >18 (i.e., moderate depression) at Screening and Baseline
Key exclusion criteria (16 listed)
- Severe personality traits (based on DSM-5 criteria) that in the opinion of the investigator may interfere with the participation in the study or the evaluation of efficacy and safety and all diagnosed Personality Disorders
- Current DSM-5 diagnosis of Neurocognitive Disorders, Schizophrenia Spectrum (lifetime diagnosis) and other Psychotic Disorders, Bipolar and Related disorders (lifetime diagnosis*), Trauma and Stress related Disorders, Obsessive Compulsive Disorder and Related Disorders. Other DSM-5 disorders that in the opinion of the investigator may interfere with the participation in the study or the evaluation of efficacy and safety.
- DSM-5 diagnosis of Substance Related and Addictive Disorders diagnosed in the last 12 months (other than tobacco and caffeine)
- History of Suicidal Behavior within 12 months of screening or presence of Active Suicidal Ideation with Intent in the past 12 months (Items 4 or 5) at Screening or Baseline, as determined by the Columbia Suicide Severity Rating Scale (C-SSRS), or subject is considered to be an acute suicide risk in the clinical judgment of the investigator
- Previous homicidal behavior or acute homicidal risk at Screening or Baseline, in the clinical judgment of the investigator
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 |
|---|---|---|
| Assay-guided treatment (AGT)Also: Genecept Assay™The assay provides information to guide pharmacotherapeutic decisions personalized to a patient's genetic profile, to maximize improvement in symptomatology and minimize treatment failure and treatment intolerability. | Genetic | Assay-guided treatment (AGT) |
| Treatment-as-usual (TAU)Subjects are treated-as-usual without the aid of the assay. | Other | Treatment-as-usual (TAU) |
Primary outcome
Mean Change From Baseline in SIGH-D-17 Score at 8 Weeks.
Time frame: Baseline to 8 Weeks
SIGH-D-17: 17-item rater-administered Structured Interview Guide of the Hamilton Depression Rating Scale Scoring is based on the 17-item scale and scores range from 0 minimum to 52 maximum. Scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression; the maximum score being 52 on the 17-point scale.
8 secondary outcomes
Mean Change From Baseline in QIDS-SR16 Score at 8 Weeks.
Time frame: Baseline to 8 Weeks
Percentage of Treatment Responders at Week 8 Based on ≥ 50% Reduction of SIGH-D-17 Score From Baseline.
Time frame: Baseline to 8 Weeks
Percentage of Treatment Responders at Week 8 Based on ≥ 50% Reduction of QIDS-SR16 Score From Baseline.
Time frame: Baseline to 8 Weeks
Percentage of Treatment Responders at Week 8 Based on ≤ 3 Score on the CGI-I.
Time frame: Baseline to 8 Weeks
Percentage of Remitters at Week 8 Based on ≤ 7 Score on the SIGH-D-17.
Time frame: Baseline to 8 Weeks
Percentage of Remitters at Week 8 Based on ≤ 5 Score on the QIDS-SR16.
Time frame: Baseline to 8 Weeks
Safety Outcomes Based on Frequency, Intensity and Burden of Side Effects Rating (FIBSER).
Time frame: Baseline to 8 Weeks
Safety Outcomes Based on Frequency and Severity of Reported Adverse Events.
Time frame: Screening to 8 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Major Depressive Disorder
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
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.
David Krause, MD study chair
Genomind CMO
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assay-guided treatment (AGT) and Treatment-as-usual (TAU) in people with Major Depressive Disorder, run by Genomind, LLC at 23 sites 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 7 inclusion and 16 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 28 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites 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 28 Aug 2020). 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?
Mean Change From Baseline in SIGH-D-17 Score at 8 Weeks. (time frame: Baseline to 8 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2020.