Treatment Resistant Major Depressive DisorderPhase 4ASCERTAINTRDNCT02977299
Comparative Effectiveness Research Trial for Antidepressant Incomplete and Non-responders With TRD
A Phase 4 study testing Aripiprazole, Repetitive transcranial magnetic stimulation (rTMS) and Venlafaxine XR in people with Treatment Resistant Major Depressive Disorder, run by Massachusetts General Hospital at 13 sites in 2 countries.
Trial summary
This is a multi-site, randomized, open-label, effectiveness trial comparing three treatment arms for Major Depressive Disorder (MDD) patients with TRD who are currently on ongoing, stable and adequate antidepressant therapy (ADT). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Treatment Resistant Major Depressive Disorder
- What is being tested?
- Aripiprazole, Repetitive transcranial magnetic stimulation (rTMS) and Venlafaxine XR
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 13 Jul 2017to 24 Apr 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women and men ages 18-80,
- with MDD, of at least 12 weeks duration, according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria confirmed by the Mini International Neuropsychiatric Interview (MINI; Sheehan et al, 1998),
- have a Montgomery-Asberg Depression Rating Scale (MADRS - Montgomery and Asberg, 1979) score of at least 20 at screen and baseline as assessed by site clinicians,
- meet criteria for TRD during the current major depressive episode documented in the MGH Antidepressant Treatment History Questionnaire (ATRQ) (Chandler et al., 2010), which will be defined as being non-responders (less than 50% of symptom improvement) to two or more depression treatment trials of adequate dose and duration as defined by the MGH ATRQ,
- are currently on an antidepressant of adequate dose (as defined by the MGH ATRQ) and duration (at least 8 weeks), with the antidepressant dose being stable over the past four weeks, and with documented (in the MGH ATRQ) non-response (less than 50% improvement) to the current antidepressant.
- Patients who have passed the MGH CTNI remote assessment, with documentation provided to sites by MGH CTNI.
Who cannot join
- pregnant or breastfeeding women, women of childbearing potential who are not using an accepted means of birth control, or women with a positive urine pregnancy test,
- patients who have received treatment with rTMS, aripiprazole, electroconvulsive therapy (ECT), or venlafaxine during the current episode,
- patients who express an objection to receiving treatment with at least one of the three treatment arms of our study,
- patients with any history of bipolar disorder or psychosis (diagnosed by MINI),
- patients with active alcohol or substance abuse disorders within the past 6 months (diagnosed by MINI),
- patients with suicidal ideation of the degree that, in the opinion of the evaluating clinician, participation in the study would place them at significantly increased risk of suicide,
Show all 16Show fewer
- patients with unstable medical issues of such degree that, in the opinion of the evaluating clinician, participation in the study would place them at significant risk of a serious adverse event, or patients with a screening hemoglobin A1c level greater than 7.5%, or patients with epilepsy, dementia, Parkinson's disease, or Huntington's Disease,
- patients who have received treatment with vagus nerve stimulation (VNS),
- patients who have not responded to more than five FDA-approved antidepressant treatment trials of adequate dose and duration during the current episode, or who did not respond to ECT in previous episodes
- patients on excluded medications,
- patients with a positive urine screen drug test for a substance for which they do not have a valid prescription for a valid medical reason,
- patients with currently abnormal thyroid function tests,
- patients who have received at least one dose of a monoamine oxidase inhibitor (MAOI) four weeks or less prior, and
- for patients on concomitant psychotropic agents (anticonvulsants, benzodiazepines, hypnotics, opiates, triiodothyronine (T3), modafinil, psychostimulants, buspirone, melatonin, omega-3 fatty acids, folate, l-methylfolate, s-adenosyl methionine, lithium) not on the same dose for at least four weeks prior to study entry or who do not agree to continue at the same dose during the acute phase of the study.
- Patients who do not meet safety criteria for TMS: history of seizures, cardiac pacemaker, DBS or VNS, brain aneurism clips or other metallic implants in the intracranial space.
- Also excluded is an individual who has received any administration of ketamine in the current episode for the treatment of depression.
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States11 sites
The University of Alabama School of Medicine
Birmingham, Alabama, 35294
Roper St. Francis Hospital
Charleston, South Carolina, 29425
Northwestern University, Feinberg School of Medicine
Chicago, Illinois, 60611
University of Cincinnati
Cincinnati, Ohio, 45219
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Baylor College of Medicine
Houston, Texas, 77030
Pacific Institute of Medical Research
Los Angeles, California, 90095
New York University
New York, New York, 10003
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Stanford University
Stanford, California, 94305
University of South Florida
Tampa, Florida, 33613
Canada2 sites
University of British Columbia
Vancouver, British Columbia
University of Manitoba St. Boniface Hospital
Winnipeg, Manitoba, R2H 2A6
About this study
Official title: Augmentation Versus Switch: Comparative Effectiveness Research Trial for Antidepressant Incomplete and Non-responders With Treatment Resistant Depression (ASCERTAIN-TRD)
This is a multi-site, randomized, open-label, effectiveness trial comparing three treatment arms for Major Depressive Disorder (MDD) patients with TRD who are currently on ongoing, stable and adequate antidepressant therapy (ADT). Adequate ADT is defined as a therapeutically sufficient dose for a sufficient treatment period, which would be expected to be effective as listed in the MGH Antidepressant Treatment Response Questionnaire (ATRQ). Patients will be randomized in a 1:1:1 fashion to one of three open-label treatment arms: a) aripiprazole augmentation, b) rTMS augmentation, and c) switching to venlafaxine XR or Duloxetine.
- Being tested
- Aripiprazole, Repetitive transcranial magnetic stimulation (rTMS), Venlafaxine XR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AripiprazoleDrug
Also called Abilify
Oral adjunctive therapy with aripiprazole, dose adjusted for effectiveness and tolerability.
Repetitive transcranial magnetic stimulation (rTMS)Device
Adjunctive therapy with transcranial magnetic stimulation, dose adjusted for effectiveness and tolerability.
Venlafaxine XRDrug
Also called Effexor XR
Oral switch therapy with venlafaxine, dose adjusted for effectiveness and tolerability.
| Study group | Role | What they receive |
|---|---|---|
| Aripiprazole Augmentation | Experimental | Patients randomized to this treatment arm will be instructed to continue all permitted psychotropics at their current dose throughout the 8-week trial and initiate adjunctive aripiprazole. The starting dose will be 5mg daily. The dose may be reduced to as low as 2mg for tolerability issues (this will be the lowest dose permitted for continuation in the trial). The dose may be adjusted in 2 or 5mg increments. The minimum time per increment will be 7 days. The maximum dose will be set at 15mg daily. For patients who are not on potent cytochrome 2D6 inhibitors (such as paroxetine, fluoxetine, duloxetine) or on potent cytochrome 3A4 inhibitors (such as fluvoxamine and nefazodone) and who are able to tolerate 15mg daily, the maximum dose can be raised to 20mg daily for efficacy. Receives: Drug: Aripiprazole |
| rTMS Augmentation | Experimental | Patients randomized to this treatment arm will be instructed to continue all permitted psychotropics at their current dose throughout the 8-week trial. We will use clinical TMS stimulators with focal figure-of-eight coils. We will start by measuring the patient´s motor threshold (MT), which is a measure of cortical excitability used to standardize the intensity of stimulation across subjects. Receives: Device: Repetitive transcranial magnetic stimulation (rTMS) |
| Switching To Venlafaxine XR | Experimental | Patients randomized to this treatment arm will be instructed to continue all permitted psychotropics throughout the 8-week trial, except for their antidepressant(s). They will be instructed to discontinue all antidepressants and initiate venlafaxine that day, as direct switch to serotonergic antidepressants is well tolerated and avoids loss of precious therapeutic time (Montgomery et al., 2014), including to switching to venlafaxine in STAR*D (Rush et al., 2006b). For patients who do not prefer a direct switch, or when clinically indicated otherwise in the opinion of the site investigator, a gradual tapering during the screening period will be permitted as long as a direct switch to venlafaxine is made on the baseline visit from the final antidepressant dose. The starting dose of venlafaxine will be 75mg daily. The dose may be reduced to as low as 37.5mg for tolerability issues (this will be the lowest dose permitted for continuation in the trial). Receives: Drug: Venlafaxine XR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Asberg Depression Rating Scale (MADRS)
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-rated scale that assesses the severity of depressive symptoms. The scale consists of 10 items evaluating apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 to 6. Item scores are summed to calculate a total MADRS score ranging from 0 to 60, with higher scores indicating more severe depressive symptoms and a worse outcome.
Measured: 8 weeks
Secondary outcomes (1)
Quality of Life, Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)
The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) is a self-reported assessment tool used to evaluate an individual's degree of enjoyment and satisfaction across various areas of daily functioning. The questionnaire assesses domains such as physical health, mood, work, household activities, social relationships, leisure activities, and overall well-being. The short form consists of 16 items, with respondents rating their level of satisfaction and functioning over the past week. The first 14 items are summed to generate a total raw score ranging from 14 to 70, with higher scores indicating greater life satisfaction and better quality of life. Raw scores may also be converted to a percentage of the maximum possible score, ranging from 0% to 100%, to facilitate interpretation and comparison across studies. The final two items assess overall medication satisfaction and overall life satisfaction and are typically analyzed separately rather than included
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2016 (estimated)
- Study start13 Jul 2017
- Primary completion24 Apr 2022
- Study completion24 Apr 2022
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 (2)Papers the sponsor has linked to this study.
- Other trials for Treatment Resistant Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, George I. Papakostas, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02977299
- Sponsor's protocol ID
- 2015P002430
- Acronym
- ASCERTAINTRD
- Status last verified
- Jun 2026
- First submitted
- 28 Nov 2016
- Last updated
- 9 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Guidetti C, Chaikali S, Trivedi MH, Shelton RC, Iosifescu DV, Thase ME, Jha MK, Mathew SH, DeBattista C, Dokucu ME, Brawman-Mintzer O, Hernandez Ortiz JM, Currier GW, McCall WV, Modirrousta M, Macaluso M, Bystritsky A, Vila-Rodriguez F, Nelson EB, Yeung AS, MacGregor LC, Carmody T, Fava M, Papakostas GI. Comparative Effectiveness Research Trial for Antidepressant Incomplete and Nonresponders With Treatment Resistant Depression (ASCERTAIN-TRD): Effect of Aripiprazole or Repetitive Transcranial Magnetic Stimulation Augmentation Versus Switching to the Antidepressant Venlafaxine on Quality of Life. J Clin Psychiatry. 2025 Aug 11;86(3):24m15614. doi: 10.4088/JCP.24m15614.
PubMed 40801757Papakostas GI, Trivedi MH, Shelton RC, Iosifescu DV, Thase ME, Jha MK, Mathew SJ, DeBattista C, Dokucu ME, Brawman-Mintzer O, Currier GW, McCall WV, Modirrousta M, Macaluso M, Bystritsky A, Rodriguez FV, Nelson EB, Yeung AS, Feeney A, MacGregor LC, Carmody T, Fava M. Comparative effectiveness research trial for antidepressant incomplete and non-responders with treatment resistant depression (ASCERTAIN-TRD) a randomized clinical trial. Mol Psychiatry. 2024 Aug;29(8):2287-2295. doi: 10.1038/s41380-024-02468-x. Epub 2024 Mar 7.
PubMed 38454079
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmentation Versus Switch: Comparative Effectiveness Research Trial for Antidepressant Incomplete and Non-responders With Treatment Resistant Depression (ASCERTAIN-TRD)
- ClinicalTrials.gov ID
- NCT02977299
- Acronym / sponsor ID
- ASCERTAINTRD / 2015P002430
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 13 Jul 2017 (actual)
- Primary completion
- 24 Apr 2022 (actual)
- Study completion
- 24 Apr 2022 (actual)
- First posted
- 30 Nov 2016 (estimated)
- Results
- Posted 9 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-site, randomized, open-label, effectiveness trial comparing three treatment arms for Major Depressive Disorder (MDD) patients with TRD who are currently on ongoing, stable and adequate antidepressant therapy (ADT). Adequate ADT is defined as a therapeutically sufficient dose for a sufficient treatment period, which would be expected to be effective as listed in the MGH Antidepressant Treatment Response Questionnaire (ATRQ). Patients will be randomized in a 1:1:1 fashion to one of three open-label treatment arms: a) aripiprazole augmentation, b) rTMS augmentation, and c) switching to venlafaxine XR or Duloxetine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aripiprazole Augmentation | Experimental | Drug: AripiprazolePatients randomized to this treatment arm will be instructed to continue all permitted psychotropics at their current dose throughout the 8-week trial and initiate adjunctive aripiprazole. The starting dose will be 5mg daily. The dose may be reduced to as low as 2mg for tolerability issues (this will be the lowest dose permitted for continuation in the trial). The dose may be adjusted in 2 or 5mg increments. The minimum time per increment will be 7 days. The maximum dose will be set at 15mg daily. For patients who are not on potent cytochrome 2D6 inhibitors (such as paroxetine, fluoxetine, duloxetine) or on potent cytochrome 3A4 inhibitors (such as fluvoxamine and nefazodone) and who are able to tolerate 15mg daily, the maximum dose can be raised to 20mg daily for efficacy. |
| rTMS Augmentation | Experimental | Device: Repetitive transcranial magnetic stimulation (rTMS)Patients randomized to this treatment arm will be instructed to continue all permitted psychotropics at their current dose throughout the 8-week trial. We will use clinical TMS stimulators with focal figure-of-eight coils. We will start by measuring the patient´s motor threshold (MT), which is a measure of cortical excitability used to standardize the intensity of stimulation across subjects. |
| Switching To Venlafaxine XR | Experimental | Drug: Venlafaxine XRPatients randomized to this treatment arm will be instructed to continue all permitted psychotropics throughout the 8-week trial, except for their antidepressant(s). They will be instructed to discontinue all antidepressants and initiate venlafaxine that day, as direct switch to serotonergic antidepressants is well tolerated and avoids loss of precious therapeutic time (Montgomery et al., 2014), including to switching to venlafaxine in STAR*D (Rush et al., 2006b). For patients who do not prefer a direct switch, or when clinically indicated otherwise in the opinion of the site investigator, a gradual tapering during the screening period will be permitted as long as a direct switch to venlafaxine is made on the baseline visit from the final antidepressant dose. The starting dose of venlafaxine will be 75mg daily. The dose may be reduced to as low as 37.5mg for tolerability issues (this will be the lowest dose permitted for continuation in the trial). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- women and men ages 18-80,
- with MDD, of at least 12 weeks duration, according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria confirmed by the Mini International Neuropsychiatric Interview (MINI; Sheehan et al, 1998),
- have a Montgomery-Asberg Depression Rating Scale (MADRS - Montgomery and Asberg, 1979) score of at least 20 at screen and baseline as assessed by site clinicians,
- meet criteria for TRD during the current major depressive episode documented in the MGH Antidepressant Treatment History Questionnaire (ATRQ) (Chandler et al., 2010), which will be defined as being non-responders (less than 50% of symptom improvement) to two or more depression treatment trials of adequate dose and duration as defined by the MGH ATRQ,
- are currently on an antidepressant of adequate dose (as defined by the MGH ATRQ) and duration (at least 8 weeks), with the antidepressant dose being stable over the past four weeks, and with documented (in the MGH ATRQ) non-response (less than 50% improvement) to the current antidepressant.
Key exclusion criteria (16 listed)
- pregnant or breastfeeding women, women of childbearing potential who are not using an accepted means of birth control, or women with a positive urine pregnancy test,
- patients who have received treatment with rTMS, aripiprazole, electroconvulsive therapy (ECT), or venlafaxine during the current episode,
- patients who express an objection to receiving treatment with at least one of the three treatment arms of our study,
- patients with any history of bipolar disorder or psychosis (diagnosed by MINI),
- patients with active alcohol or substance abuse disorders within the past 6 months (diagnosed by MINI),
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 |
|---|---|---|
| AripiprazoleAlso: AbilifyOral adjunctive therapy with aripiprazole, dose adjusted for effectiveness and tolerability. | Drug | Aripiprazole Augmentation |
| Repetitive transcranial magnetic stimulation (rTMS)Adjunctive therapy with transcranial magnetic stimulation, dose adjusted for effectiveness and tolerability. | Device | rTMS Augmentation |
| Venlafaxine XRAlso: Effexor XROral switch therapy with venlafaxine, dose adjusted for effectiveness and tolerability. | Drug | Switching To Venlafaxine XR |
Primary outcome
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: 8 weeks
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-rated scale that assesses the severity of depressive symptoms. The scale consists of 10 items evaluating apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 to 6. Item scores are summed to calculate a total MADRS score ranging from 0 to 60, with higher scores indicating more severe depressive symptoms and a worse outcome.
1 secondary outcome
Quality of Life, Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40801757Guidetti C, Chaikali S, Trivedi MH, Shelton RC, Iosifescu DV, Thase ME, Jha MK, Mathew SH, DeBattista C, Dokucu ME, Brawman-Mintzer O, Hernandez Ortiz JM, Currier GW, McCall WV, Modirrousta M, Macaluso M, Bystritsky A, Vila-Rodriguez F, Nelson EB, Yeung AS, MacGregor LC, Carmody T, Fava M, Papakostas GI. Comparative Effectiveness Research Trial for Antidepressant Incomplete and Nonresponders With Treatment Resistant Depression (ASCERTAIN-TRD): Effect of Aripiprazole or Repetitive Transcranial Magnetic Stimulation Augmentation Versus Switching to the Antidepressant Venlafaxine on Quality of Life. J Clin Psychiatry. 2025 Aug 11;86(3):24m15614. doi: 10.4088/JCP.24m15614.
- Derived from this study: PubMed 38454079Papakostas GI, Trivedi MH, Shelton RC, Iosifescu DV, Thase ME, Jha MK, Mathew SJ, DeBattista C, Dokucu ME, Brawman-Mintzer O, Currier GW, McCall WV, Modirrousta M, Macaluso M, Bystritsky A, Rodriguez FV, Nelson EB, Yeung AS, Feeney A, MacGregor LC, Carmody T, Fava M. Comparative effectiveness research trial for antidepressant incomplete and non-responders with treatment resistant depression (ASCERTAIN-TRD) a randomized clinical trial. Mol Psychiatry. 2024 Aug;29(8):2287-2295. doi: 10.1038/s41380-024-02468-x. Epub 2024 Mar 7.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aripiprazole, Repetitive transcranial magnetic stimulation (rTMS) and Venlafaxine XR in people with Treatment Resistant Major Depressive Disorder, run by Massachusetts General Hospital at 13 sites in 2 countries.
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 6 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 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Canada. 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 9 Jul 2026). 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?
Montgomery-Asberg Depression Rating Scale (MADRS) (time frame: 8 weeks). 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 NCT02977299, which also lists 2 linked publications.
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 9 Jul 2026.