Major Depressive DisorderPhase 4NCT02972632
Goal Achievement After a Change to Vortioxetine in Adults With Major Depressive Disorder
A Phase 4 study testing Vortioxetine in people with Major Depressive Disorder, run by Takeda at 25 sites in United States.
Trial summary
The purpose of this study is to determine the effectiveness of treatment with vortioxetine on participant goal achievement after a change in antidepressant medication for the treatment of major depressive disorder (MDD). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Vortioxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 25 sitesUnited States
- Study dates
- 22 Dec 2016to 6 Feb 2018
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is suffering from Major Depressive Disorder (MDD) as the primary psychiatric diagnosis.
- Has been or is currently being treated with an approved antidepressant (monotherapy) for 6 weeks or longer at an adequate therapeutic dose. Participants currently on an antidepressant at Screening will be discontinued in a manner that is consistent with labeling recommendations and conventional medical practice.
- The antidepressant treatment must be on-going at time of Screening or have been discontinued within the 6 weeks prior to Screening.
- Is considered appropriate for a change in antidepressant medication based on Investigator judgment in collaboration with the participant.
- Has scores on Patient Health Questionnaire (PHQ-9) ≥5 and Clinical Global Impression Scale Severity (CGI-S ≥4).
Who cannot join
- Has discontinued prior antidepressant treatment greater than 6 weeks from Screening.
- Is considered to be at imminent risk for hospitalization due to severe depression in the opinion of the investigator. Recent hospitalization due to MDD within 3 months prior to Screening is exclusionary also.
- Has a significant risk of suicide according to the Investigator's clinical judgment or has made an actual suicide attempt in the previous 6 months prior to Screening or scores "yes" on items 4 or 5 in the past 6 months on the Suicidal Ideation section of the Columbia Suicide Severity Rating Scale (C-SSRS).
- Is considered to be treatment resistant, defined as participants with MDD who have not responded to 2 or more separate different antidepressant monotherapy trials of adequate dose and duration (6 weeks or longer) in their current episode. History of only responding to combination or augmentation therapy in previous major depressive episode (MDEs) is also considered evidence of treatment resistant depression.
- Has 1 or more of the following:
- Current or history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder, including schizoaffective disorder, major depression with psychotic features, bipolar depression with psychotic features, obsessive compulsive disorder, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in Diagnostic and Statistical Manual of Mental Disorders (DSM-5) as determined by the investigator.
Show all 16Show fewer
- Current diagnosis or history of alcohol or other substance abuse or dependence (excluding nicotine or caffeine). The participants must have a negative urine drug screen (UDS) at Screening and Baseline, this includes benzodiazepines and opiates (including oxycodone) for which there is no prescription.
- Presence or history of a clinically significant neurological disorder (including epilepsy) as determined by the investigator.
- Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc).
- Has a known history of acute narrow-angle glaucoma or is at risk of acute narrow-angle glaucoma.
- Has a known unstable thyroid disorder or a thyroid-stimulating hormone value outside the normal range based on medical history that is deemed clinically significant by the investigator.
- Has active hepatitis B or a known history of hepatitis C virus.
- Has a known history of human immunodeficiency virus infection.
- Has a history of gastric bypass.
- Has previously or is currently participating in this study or another vortioxetine or LuAA21004 study.
- Is receiving or who have started receiving formal cognitive or behavioral therapy, systematic psychotherapy within 30 days from screening or plan to initiate such therapy during the study.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
University of Michigan, Ann Arbor
Ann Arbor, Michigan, 48109
Great Lakes Clinical Trials
Chicago, Illinois, 60640
MCB Clinical Research Centers, LLC
Colorado Springs, Colorado, 80910
ATP Clinical Research, Inc.
Costa Mesa, California, 92626
ProScience Research Group
Culver City, California, 90230
Relaro Medical Trials
Dallas, Texas, 75243
Dayton Clinical Research
Dayton, Ohio, 45406
Deaconess Clinic
Evansville, Indiana, 47713-1227
Behavioral Research Specialists, LLC
Glendale, California, 91206
Red Oak Psychiatry Associates, PA
Houston, Texas, 77090
Green & Seidner Family Practice Associates
Lansdale, Pennsylvania, 19446
Baber Research Group
Naperville, Illinois, 60563
Novex Clinical Research, LLC
New Bedford, Massachusetts, 2740
Suncoast Clinical Research Inc.
New Port Richey, Florida, 34652
Columbia University Medical Center
New York, New York, 10023
Behavioral Clinical Research , Inc
North Miami, Florida, 33162
Pacific Research Partners
Oakland, California, 94607
Excell Research
Oceanside, California, 92056
Compass Research Main
Orlando, Florida, 32806
Anderson Clinical Research
Redlands, California, 92374
Radiant Research, Inc.
San Antonio, Texas, 78229
Coastal Research Associates, Inc.
South Weymouth, Massachusetts, 2190
University of South Florida
Tampa, Florida, 33613
Family Psychiatry of The Woodlands
The Woodlands, Texas, 77381
University Medical Group
Upland, California, 91207
About this study
Official title: An Open-Label, Single-Arm, Multicenter, Prospective, Phase 4, Interventional, Flexible Dose Study to Evaluate the Effectiveness of Vortioxetine on Goal Achievement After a Change in Antidepressant Medication for the Treatment of Subjects With Major Depressive Disorder
The purpose of this study is to determine the effectiveness of treatment with vortioxetine on participant goal achievement after a change in antidepressant medication for the treatment of major depressive disorder (MDD).
Read the detailed description
The drug being tested in this study is called Vortioxetine. Vortioxetine is being tested to treat depression in people who have major depressive disorder. This study will look at effectiveness of treatment with vortioxetine in participant's goal achievement for the treatment of major depressive disorder.
The study enrolled 123 patients. Participants will receive:
- Vortioxetine 10 to 20 mg
All participants will be asked to take one tablet at the same time each day throughout the study. The participants will receive a starting dose of 10 mg. The dose may be up-titrated to 20 mg. The dose may then be decreased by 5 mg based on participant's response and tolerability to higher dose as judged by the Investigator.
This multi-center trial will be conducted in Unites States. The overall time to participate in this study is 19 weeks. Participants will make multiple visits to the clinic and will be contacted by telephone for 4 weeks after last dose of study drug for a follow-up assessment.
- Conditions
- Major Depressive Disorder
- Being tested
- Vortioxetine
- Keywords
- Drug Therapy
- 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.
VortioxetineDrug
Also called LuAA21004
Vortioxetine tablet
| Study group | Role | What they receive |
|---|---|---|
| Vortioxetine 10-20 mg | Experimental | Vortioxetine 10 mg, tablets, orally, once daily followed by a dose adjustment to a maximum of 20 mg, tablets, orally, once daily up to 12 weeks. The dose may be decreased by 5 mg based on participant's response and tolerability as judged by the investigator. Receives: Drug: Vortioxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Achieved Goal Attainment Scale (GAS) Score of ≥50 at Week 12
GAS is a tool to measure progress each participant has towards achieving their individualized goals. The standardized scoring was applied for statistical analysis. A semi-structured interview was conducted with each participant to conduct goal-setting at the outset of study. Another evaluation took place at end of study (EOS) visit to determine the level of progress at that time. The score for each goal ranged from -2 (much worse) to +2 (much better). GAS yielded a norm-based score standardized to a mean of 50 with a standard deviation (SD) of 10. Higher score indicates composite of 3 goals (50 or above) as response.
Measured: Week 12
Secondary outcomes (7)
Change From Baseline in Total Goal Attainment Scale Score at Weeks 6 and 12
GAS is a tool to measure progress each participant has towards achieving their individualized goals. The standardized scoring was applied for statistical analysis. A semi-structured interview was conducted with each participant to conduct goal-setting at outset of study. Another evaluation took place at EOS visit to determine level of progress at that time. The score for each goal ranged from -2 (much worse) to +2 (much better). GAS yielded a norm-based score standardized to a mean of 50 with SD of 10. The total score ranges between 22.6 and 77.4. A positive change from baseline in the composite of 3 goals (50 or above) indicates response.
Measured: Baseline and Weeks 6 and 12
Change From Baseline in Patient Health Questionnaire (PHQ-9) Score at Weeks 6 and 12
PHQ-9 is a well-established participant reported outcome tool for assessment of change in depressive symptoms and is a sensitive measure of depression severity. The PHQ-9 consists of a 9-item scale originally developed for primary care settings, with 1 item corresponding to each of the 9 made symptom criteria for depression in diagnostic and statistical manual of mental disorders (DSM), asking if they have bothered the participant over the last 2 weeks. Each question is rated on a scale from 0 (not at all) to 3 (nearly every day). If any problems are answered 1 or higher, a final question on how difficult those problems made it to do work, take care of things at home, or get along with other people is completed, rated from not difficult at all to extremely difficult. The 9 questions are summed to a total score ranging from 0 to 27 with higher scores reflecting greater severity. A positive change from baseline indicates severe condition.
Measured: Baseline and Weeks 6 and 12
Change From Baseline in Perceived Deficits Questionnaire-Depression (PDQ-D) at Weeks 6 and 12
The PDQ-D is a 20-item, patient-reported questionnaire with a 7-day recall period. Scores for four subscales. All 20 items use the same 5-point ordinal categorical response scale to reflect the frequency of experiencing a specific cognitive problem in the past 7 days. Scores for each of the four measured subscales are calculated by assigning a value of 0 ("never in the past 7 days"), 1 ("rarely - once or twice"), 2 ("sometimes - 3-5 times"), 3 ("often - about once a day"), or 4 ("very often - more than once a day") to each item, then summing the five items of that subscale, to produce a score ranging from 0 to 20. A total global score for overall cognitive dysfunction (range 0-80) is calculated by summing the four subscale scores. Higher scores for each subscale and for the total score indicate greater perceived cognitive dysfunction. A negative change from Baseline indicates improvement.
Measured: Baseline and Weeks 6 and 12
Change From Baseline in Quality of Life Enjoyment and Satisfaction Scale (Q-LES-Q) Total Score at Week 12
Q-LES-Q is a scale designed to allow researchers to assess the degree of a participant's quality of life in various areas of daily living. There is not a "Total Score" per se for the Q-LES-Q. The scale is divided into domains. Ninety-one of the 93 items are assembled into 8 categories: physical health/activities, feelings, work, household duties, school/course work, leisure time activities, social relations, and general activities. Items are scored on a 5 point scale, from 1 (not at all or never) to 5 (frequently or all the time), to indicate the degree of enjoyment or satisfaction experienced by domain. Raw summary scores are expressed as a percentage of the maximum possible score within a given domain to facilitate comparisons across areas of functioning. The total score is based on the Overall Life Satisfaction question in General Activities and ranges from 1 to 5. A positive change from baseline indicates greater enjoyment/satisfaction.
Measured: Baseline and Week 12
Change From Baseline in 5-Item World Health Organization Well-being Index (WHO-5) Score at Week 12
WHO-5 is a short, self-administered questionnaire covering 5 positively worded items, related to positive mood (good spirits, relaxation), vitality (being active and waking up fresh and rested), and general interests (being interested in things). Each of the five items is rated from 0 (= not present) to 5 (= constantly present). Scores are summated, with raw score ranging from 0 to 25, with higher score meaning better well-being. A positive change from baseline indicates improvement.
Measured: Baseline and Week 12
Change From Baseline in Clinical Global Impression Scale Severity (CGI-S) at Week 12
CGI-S is a clinician rated scale designed to assess global severity of illness and change in the clinical condition over time. The CGI-S provides the clinician's impression of the participant's state of mental illness. The clinician uses his or her clinical experience of this participant population to rate the severity of the participant's mental illness on a 7-point scale ranging from 1 (normal-not at all ill) to 7 (among the most extremely ill participants). Higher scores indicate greater severity of illness. A negative change from baseline indicates improvement.
Measured: Baseline and Week 12
Clinical Global Impression Scale-Improvement (CGI-I) Score at Week 12
CGI-I assesses the participant's improvement (or worsening). The clinician assessed participant's condition on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Higher scores indicated greater severity of illness.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2016 (estimated)
- Study start22 Dec 2016
- Primary completion6 Feb 2018
- Study completion6 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by TakedaThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director Clinical Science, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02972632
- Sponsor's protocol ID
- Vortioxetine-4003
- Other IDs
- U1111-1185-6902
- Status last verified
- Jun 2019
- First submitted
- 21 Nov 2016
- Last updated
- 11 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
Publications
McCue M, Sarkey S, Eramo A, Francois C, Parikh SV. Using the Goal Attainment Scale adapted for depression to better understand treatment outcomes in patients with major depressive disorder switching to vortioxetine: a phase 4, single-arm, open-label, multicenter study. BMC Psychiatry. 2021 Dec 11;21(1):622. doi: 10.1186/s12888-021-03608-1.
PubMed 34895181
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Arm, Multicenter, Prospective, Phase 4, Interventional, Flexible Dose Study to Evaluate the Effectiveness of Vortioxetine on Goal Achievement After a Change in Antidepressant Medication for the Treatment of Subjects With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT02972632
- Acronym / sponsor ID
- Vortioxetine-4003
- Conditions
- Major Depressive Disorder
- Keywords
- Drug Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 22 Dec 2016 (actual)
- Primary completion
- 6 Feb 2018 (actual)
- Study completion
- 6 Feb 2018 (actual)
- First posted
- 23 Nov 2016 (estimated)
- Results
- Posted 11 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effectiveness of treatment with vortioxetine on participant goal achievement after a change in antidepressant medication for the treatment of major depressive disorder (MDD).
Detailed description
The drug being tested in this study is called Vortioxetine. Vortioxetine is being tested to treat depression in people who have major depressive disorder. This study will look at effectiveness of treatment with vortioxetine in participant's goal achievement for the treatment of major depressive disorder.
The study enrolled 123 patients. Participants will receive:
- Vortioxetine 10 to 20 mg
All participants will be asked to take one tablet at the same time each day throughout the study. The participants will receive a starting dose of 10 mg. The dose may be up-titrated to 20 mg. The dose may then be decreased by 5 mg based on participant's response and tolerability to higher dose as judged by the Investigator.
This multi-center trial will be conducted in Unites States. The overall time to participate in this study is 19 weeks. Participants will make multiple visits to the clinic and will be contacted by telephone for 4 weeks after last dose of study drug for a follow-up assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vortioxetine 10-20 mg | Experimental | Drug: VortioxetineVortioxetine 10 mg, tablets, orally, once daily followed by a dose adjustment to a maximum of 20 mg, tablets, orally, once daily up to 12 weeks. The dose may be decreased by 5 mg based on participant's response and tolerability as judged by the investigator. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Is suffering from Major Depressive Disorder (MDD) as the primary psychiatric diagnosis.
- Has been or is currently being treated with an approved antidepressant (monotherapy) for 6 weeks or longer at an adequate therapeutic dose. Participants currently on an antidepressant at Screening will be discontinued in a manner that is consistent with labeling recommendations and conventional medical practice.
- The antidepressant treatment must be on-going at time of Screening or have been discontinued within the 6 weeks prior to Screening.
- Is considered appropriate for a change in antidepressant medication based on Investigator judgment in collaboration with the participant.
- Has scores on Patient Health Questionnaire (PHQ-9) ≥5 and Clinical Global Impression Scale Severity (CGI-S ≥4).
Key exclusion criteria (16 listed)
- Has discontinued prior antidepressant treatment greater than 6 weeks from Screening.
- Is considered to be at imminent risk for hospitalization due to severe depression in the opinion of the investigator. Recent hospitalization due to MDD within 3 months prior to Screening is exclusionary also.
- Has a significant risk of suicide according to the Investigator's clinical judgment or has made an actual suicide attempt in the previous 6 months prior to Screening or scores "yes" on items 4 or 5 in the past 6 months on the Suicidal Ideation section of the Columbia Suicide Severity Rating Scale (C-SSRS).
- Is considered to be treatment resistant, defined as participants with MDD who have not responded to 2 or more separate different antidepressant monotherapy trials of adequate dose and duration (6 weeks or longer) in their current episode. History of only responding to combination or augmentation therapy in previous major depressive episode (MDEs) is also considered evidence of treatment resistant depression.
- Has 1 or more of the following:
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 |
|---|---|---|
| VortioxetineAlso: LuAA21004Vortioxetine tablet | Drug | Vortioxetine 10-20 mg |
Primary outcome
Percentage of Participants Who Achieved Goal Attainment Scale (GAS) Score of ≥50 at Week 12
Time frame: Week 12
GAS is a tool to measure progress each participant has towards achieving their individualized goals. The standardized scoring was applied for statistical analysis. A semi-structured interview was conducted with each participant to conduct goal-setting at the outset of study. Another evaluation took place at end of study (EOS) visit to determine the level of progress at that time. The score for each goal ranged from -2 (much worse) to +2 (much better). GAS yielded a norm-based score standardized to a mean of 50 with a standard deviation (SD) of 10. Higher score indicates composite of 3 goals (50 or above) as response.
7 secondary outcomes
Change From Baseline in Total Goal Attainment Scale Score at Weeks 6 and 12
Time frame: Baseline and Weeks 6 and 12
Change From Baseline in Patient Health Questionnaire (PHQ-9) Score at Weeks 6 and 12
Time frame: Baseline and Weeks 6 and 12
Change From Baseline in Perceived Deficits Questionnaire-Depression (PDQ-D) at Weeks 6 and 12
Time frame: Baseline and Weeks 6 and 12
Change From Baseline in Quality of Life Enjoyment and Satisfaction Scale (Q-LES-Q) Total Score at Week 12
Time frame: Baseline and Week 12
Change From Baseline in 5-Item World Health Organization Well-being Index (WHO-5) Score at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Clinical Global Impression Scale Severity (CGI-S) at Week 12
Time frame: Baseline and Week 12
Clinical Global Impression Scale-Improvement (CGI-I) Score at Week 12
Time frame: Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34895181McCue M, Sarkey S, Eramo A, Francois C, Parikh SV. Using the Goal Attainment Scale adapted for depression to better understand treatment outcomes in patients with major depressive disorder switching to vortioxetine: a phase 4, single-arm, open-label, multicenter study. BMC Psychiatry. 2021 Dec 11;21(1):622. doi: 10.1186/s12888-021-03608-1.
- Individual participant dataSharing planned: Yes. Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
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.
Medical Director Clinical Science study director
Takeda
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vortioxetine in people with Major Depressive Disorder, run by Takeda at 25 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 5 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 11 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jul 2019). 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?
Percentage of Participants Who Achieved Goal Attainment Scale (GAS) Score of ≥50 at Week 12 (time frame: Week 12). 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 NCT02972632, which also lists 1 linked publication.
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 11 Jul 2019.