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Major Depressive DisorderPhase 3VAST-DNCT01421342

VA Augmentation and Switching Treatments for Improving Depression Outcomes

A Phase 3 study testing Switching: Bupropion-SR, Augmenting: Antidepressant + Bupropion-SR and Augmenting: Antidepressant + Aripiprazole in people with Major Depressive Disorder, run by VA Office of Research and Development at 35 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The overall purpose is to determine research based 'next-steps' for outpatients with major depressive disorder who have not had satisfactory outcomes to standard 'first-step' treatments. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Major Depressive Disorder
What is being tested?
Switching: Bupropion-SR, Augmenting: Antidepressant + Bupropion-SR and Augmenting: Antidepressant + Aripiprazole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,522 participants
Where
35 sitesUnited States
Study dates
Dec 2012to Jun 2016
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • DSM-IV diagnosis of single or recurrent, non-psychotic, major depressive disorder
  • Currently taking a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) or mirtazapine for major depressive disorder
  • Need for "next-step" treatment based on documented suboptimal outcome from current antidepressant treatment for major depressive episode (at least 6 weeks treatment with a QIDS-C16 >= 16 or at least 8 weeks with a QIDS-C16 >= 11; and at least 3 weeks at a stable "optimal" dose
  • Age: 18 years of age or older

Who cannot join

  • Prior inadequate response after an adequate treatment trial or clear cut intolerance to either of the study medications (aripiprazole or bupropion)
  • Current treatment with bupropion, aripiprazole or any other antipsychotic agent
  • Lifetime history of bipolar disorder, schizophrenia, schizoaffective disorder, or psychosis not otherwise specified
  • Current diagnosis of Dementia
  • Current diagnosis of an eating disorder or a seizure disorder
  • High suicide risk currently requiring acute intervention (other than outpatient treatment of depression)
Show all 14Show fewer
  • Unstable, serious medical condition or one requiring acute medical treatment, or anticipation of hospitalization for extended care
  • Requiring immediate hospitalization for psychiatric disorders
  • Physiologic substance dependence requiring detoxification (excluding nicotine) in the past 30 days (substance abuse is not an exclusion criteria)
  • Taking any concomitant medication that contraindicates any of treatment options or augmenting agents known to have an antidepressant effect
  • Concurrent or recent participation (within the last 30 days) in another conflicting clinical trial with a mental health, investigational drug, or medical device intervention
  • Female - pregnant or lactating or planning to become pregnant
  • Patient was not able or willing to provide informed consent; or changed mind about participating prior to randomization
  • Patient was not referred to the study

Trial locations and contacts

35 sites in 1 country.

35 sites in 1 country

United States35 sites

  • New Mexico VA Health Care System, Albuquerque, NM

    Albuquerque, New Mexico, 87108-5153

  • Asheville VA Medical Center, Asheville, NC

    Asheville, North Carolina, 28805

  • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

    Baltimore, Maryland, 21201

  • Cincinnati VA Medical Center, Cincinnati, OH

    Cincinnati, Ohio, 45220

  • Clarksburg Louis A. Johnson VA Medical Center, Clarksburg, WV

    Clarksburg, West Virginia, 26301

  • Louis Stokes VA Medical Center, Cleveland, OH

    Cleveland, Ohio, 44106

  • Atlanta VA Medical and Rehab Center, Decatur, GA

    Decatur, Georgia, 30033

  • VA Eastern Colorado Health Care System, Denver, CO

    Denver, Colorado, 80220

  • Edward Hines Jr. VA Hospital, Hines, IL

    Hines, Illinois, 60141-5000

  • Richard L. Roudebush VA Medical Center, Indianapolis, IN

    Indianapolis, Indiana, 46202-2884

  • Kansas City VA Medical Center, Kansas City, MO

    Kansas City, Missouri, 64128

  • VA Loma Linda Healthcare System, Loma Linda, CA

    Loma Linda, California, 92357

  • VA Long Beach Healthcare System, Long Beach, CA

    Long Beach, California, 90822

  • William S. Middleton Memorial Veterans Hospital, Madison, WI

    Madison, Wisconsin, 53705

  • Memphis VA Medical Center, Memphis, TN

    Memphis, Tennessee, 38104

  • Miami VA Healthcare System, Miami, FL

    Miami, Florida, 33125

  • Clement J. Zablocki VA Medical Center, Milwaukee, WI

    Milwaukee, Wisconsin, 53295-1000

  • Minneapolis VA Health Care System, Minneapolis, MN

    Minneapolis, Minnesota, 55417

  • Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE

    Omaha, Nebraska, 68105-1873

  • VA Palo Alto Health Care System, Palo Alto, CA

    Palo Alto, California, 94304-1290

  • Philadelphia VA Medical Center, Philadelphia, PA

    Philadelphia, Pennsylvania, 19104

  • Phoenix VA Health Care System, Phoenix, AZ

    Phoenix, Arizona, 85012

  • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

    Pittsburgh, Pennsylvania, 15240

  • Salem VA Medical Center, Salem, VA

    Salem, Virginia, 24153

  • Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC

    Salisbury, North Carolina, 28144

  • VA San Diego Healthcare System, San Diego, CA

    San Diego, California, 92161

  • San Francisco VA Medical Center, San Francisco, CA

    San Francisco, California, 94121

  • St. Louis VA Medical Center John Cochran Division, St. Louis, MO

    St Louis, Missouri, 63106

  • VA Puget Sound Health Care System American Lake Division, Tacoma, WA

    Tacoma, Washington, 98493

  • James A. Haley Veterans' Hospital, Tampa, FL

    Tampa, Florida, 33612

  • Central Texas Veterans Health Care System, Temple, TX

    Temple, Texas, 76504

  • Southern Arizona VA Health Care System, Tucson

    Tucson, Arizona, 85723

  • Tuscaloosa VA Medical Center, Tuscaloosa, AL

    Tuscaloosa, Alabama, 35404

  • Washington DC VA Medical Center, Washington, DC

    Washington D.C., District of Columbia, 20422

  • VA Connecticut Healthcare System West Haven Campus, West Haven, CT

    West Haven, Connecticut, 06516

Other trials in United States

About this study

Official title: CSP #576 - VA Augmentation and Switching Treatments for Improving Depression Outcomes (VAST-D)

The overall purpose is to determine research based 'next-steps' for outpatients with major depressive disorder who have not had satisfactory outcomes to standard 'first-step' treatments. The primary objective is to compare the acute (up to 12 weeks) treatment effectiveness of augmenting an antidepressant with aripiprazole or with bupropion-slow release (SR) vs. switching treatment to bupropion-SR monotherapy on symptom remission in Veterans with Major Depressive Disorder (MDD) who have not achieved optimal response after an adequate trial on antidepressant (a selective serotonin reuptake inhibitor [SSRI] or serotonin and norepinephrine reuptake inhibitor [SNRI] or mirtazapine) monotherapy. The secondary objectives are to compare the acute (up to 12 weeks) and long term (up to 36 weeks) efficacy, safety, effects on functioning, suicidality, quality of life, anxiety and other associated symptoms, costs and cost-effectiveness of each of the three treatments.

Read the detailed description

The overall aim of VAST-D is to enhance treatment outcomes for representative outpatients diagnosed with nonpsychotic major depressive disorder (MDD) and treated in primary or psychiatric VA care settings. In particular, VAST-D is designed to determine the comparative effectiveness of different treatment options for participants with MDD who fail to have a satisfactory outcome to treatment with their initial antidepressants.

These options may be conceptualized as representing two overall treatment strategies: 1) Medication Switch - switching from the initial antidepressant to another antidepressant medication, specifically bupropion-SR and 2) Medication Augmentation - augmenting the initial antidepressant with a second antidepressant, specifically bupropion-SR or a second generation antipsychotic, specifically aripiprazole. VAST-D's primary goal is to determine which of these 3 treatment strategies is most likely to lead to remission. Other key objectives include comparisons of response, time to remission, time to response, relapse, anxiety symptoms, suicidal ideation and behaviors, side effects, tolerability, quality of life, health related costs and satisfaction with participation in the study.

VAST-D will enroll 1518 total patients of both genders and all ethnic/racial and socioeconomic backgrounds. All patients will meet Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV-TR (text revised) criteria for nonpsychotic MDD. The diagnostic criteria for eligibility will be established by clinical interview supplemented with the 9-item Patient Health Questionnaire (PHQ-9). Final determination for eligibility will be made by the study clinician. Only participants with a suboptimal outcome to a well documented, adequately delivered (dose and duration), trial with selective serotonin reuptake inhibitor (SSRI) or a serotonin and norepinephrine reuptake inhibitor (SNRI) or mirtazapine will be eligible for the study. Failure to achieve an adequate outcome will be ascertained by a score on the 16-item Quick Inventory of Depressive Symptomatology - Clinician rated (QIDS-C16) scale >= 16 (considered severe depression) after at least 6 weeks of treatment or QIDS-C16 >= 11 (considered moderately severe depression) after at least 8 weeks of treatment. Otherwise, the inclusion criteria are broad and the exclusion criteria are few; participants with most comorbid general medical or psychiatric disorders are generally included to provide a broadly representative sample.

Participants will be randomized (1:1:1 ratio) to switch to bupropion-SR alone (n=506), current antidepressant plus bupropion-SR (n=506), or current antidepressant plus aripiprazole (n=506). Treatment will be guided by clinician-rated symptom measures (the PHQ-9) and global side effects measures (the Frequency, Intensity, and Burden of Side Effects Rating or FIBSER) obtained at each treatment visit. Acute treatment visits will occur at baseline and at weeks 1, 2, 4, 6, 8, 10, and 12 to ensure delivery of appropriate and yet vigorous and tolerable pharmacotherapy. Participants who tolerate the acute treatment and achieve adequate response at 12 weeks will enter the 24-week Continuation Treatment phase, during which the initial treatment will continue and visits will occur every four weeks subsequently until patients have been followed for 36 weeks post-randomization. The QIDS-C16 will be administered at baseline and at each follow-up visit by an independent evaluator (who will be blinded to treatment assignment) to measure symptoms of depression for the study outcomes of remission, response and relapse. Neither the participant nor the treating clinician will be blinded to treatment.

Primary hypotheses:

Primary hypothesis 1.a: Remission rate from major depressive disorder will be higher in patients whose treatment is augmented with bupropion-SR (antidepressant + bupropion-SR) compared to those switched to bupropion-SR monotherapy.

Primary Hypothesis 1.b: Remission rate from major depressive disorder will be higher in patients whose treatment is augmented with aripiprazole (antidepressant + aripiprazole) compared to those switched to bupropion-SR monotherapy.

Secondary hypotheses:

Secondary Hypothesis 2.a: Remission rate will be greater in patients whose treatment is augmented with bupropion-SR (antidepressant + bupropion-SR) than in those augmented with aripiprazole (antidepressant + aripiprazole).

Secondary Hypothesis 2.b: Relapse rate (within 36 weeks of the initiation of treatment) will be lower in patients whose antidepressant is augmented with bupropion-SR (antidepressant + bupropion-SR) than in those whose antidepressant is switched to bupropion-SR monotherapy.

Secondary Hypothesis 2.c: Relapse rate (within 36 weeks of the initiation of treatment) will be lower in patients whose treatment is augmented with aripiprazole (antidepressant + aripiprazole) vs. those switched to bupropion-SR monotherapy.

Secondary Hypothesis 2.d: Relapse rate (within 36 weeks of the initiation of treatment) will be lower in patients whose treatment is augmented with bupropion-SR (antidepressant + bupropion-SR) than in patients whose treatment was augmented with aripiprazole (antidepressant + aripiprazole).

Secondary Hypothesis 2.e: The proportion of patients who develop akathisia, other akathisia-like side effects (e.g., tremor, irritability, motor restlessness) and extrapyramidal side effects will be greater in the patients whose antidepressant treatment is augmented with aripiprazole (antidepressant + aripiprazole) compared to patients whose treatment is augmented with bupropion-SR (antidepressant + bupropion-SR), or switched to bupropion-SR monotherapy.

Secondary Hypothesis 2.f: The relative costs (direct and indirect) of augmenting an antidepressant with aripiprazole (antidepressant + aripiprazole) will be greater than the costs of antidepressant augmentation with bupropion-SR (antidepressant + bupropion-SR), and the costs of antidepressant augmentation with bupropion-SR (antidepressant + bupropion-SR) will be greater than the costs of switching to bupropion-SR monotherapy, and augmentation and monotherapy with bupropion-SR will be more cost-effective than aripiprazole augmentation.

Being tested
Switching: Bupropion-SR, Augmenting: Antidepressant + Bupropion-SR, Augmenting: Antidepressant + Aripiprazole
Keywords
Mood Disorder, Depression, Depressive Disorder, Depressive Disorder, Major, Bupropion, Aripiprazole, Remission, Relapse, Cost-Effectiveness, Atypical Antipsychotic, Antidepressant, Augmentation, Veterans, Mental Health
Medical subject headings
Depressive Disorder, Major, Mood Disorders, Depression, Depressive Disorder, Recurrence, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Switching: Bupropion-SRDrug

    Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.

  • Augmenting: Antidepressant + Bupropion-SRDrug

    Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment, or adjust depending on response or side effect profile for up to 36 weeks.

    And

    Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.

  • Augmenting: Antidepressant + AripiprazoleDrug

    Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment or adjust depending on response or side effect profile for up to 36 weeks.

    And

    Aripiprazole (Dose: 2 mg - 15 mg taken orally once per day for up to 36 weeks): Initiating with aripiprazole dose of 2 mg for one week, then increasing dose per protocol up to 15 mg, maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.

Study groups in NCT01421342
Study groupRoleWhat they receive
Switching: Bupropion-SRActive comparatorSwitching: Bupropion-SR
Receives: Drug: Switching: Bupropion-SR
Augmenting: Antidepressant + Bupropion-SRActive comparatorAugmenting: Antidepressant + Bupropion-SR
Receives: Drug: Augmenting: Antidepressant + Bupropion-SR
Augmenting: Antidepressant + AripiprazoleActive comparatorAugmenting: Antidepressant + Aripiprazole
Receives: Drug: Augmenting: Antidepressant + Aripiprazole

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of Protocol Remission of Symptoms of Major Depressive Disorder

    Remission of symptoms of major depression during the acute treatment phase (12 weeks) defined as a sustained clinician-rated Quick Inventory of Depressive Symptoms (QIDS-C16) of <= 5 for two consecutive visits.

    Measured: During acute phase (12 weeks)

Secondary outcomes (3)

  1. Rate of Protocol Relapse of Symptoms of Major Depression After Achieving Remission in the Acute Phase

    Relapse in symptoms of major depression defined as a QIDS-C16 => 11 among those achieving remission in the acute phase.

    Measured: Within 36 weeks after randomization (initiation of treatment)

  2. Rate of Protocol Response as Reduction in Symptoms of Major Depression (>= 50% Reduction in QIDS-C)

    Response measured as reduction in symptom score for major depression defined as: 1. a reduction in QIDS-C16 of 50% or greater

    Measured: During acute phase (up to 12 weeks)

  3. Rate of Protocol Response Measured as a Change in Clinical Global Impression (CGI) - Improvement Scale

    Clinical assessment of a participant's level of depression and treatment response assessed by the Clinical Global Impression - Improvement (CGI -I) Scale, a 7-point clinician rating scale of improvement from baseline in severity of depression (Guy 1976). A secondary outcome measure of response was defined as achieving a score of 2 (much improved) or 1 (very much improved).

    Measured: During acute phase (up to 12 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2011 (estimated)
  2. Study startDec 2012
  3. Primary completionAug 2015
  4. Study completionJun 2016

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,522 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01421342
Sponsor's protocol ID
576
Acronym
VAST-D
Status last verified
Apr 2018
First submitted
5 Aug 2011
Last updated
29 May 2018
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Mohamed S, Johnson GR, Vertrees JE, Guarino PD, Weingart K, Young IT, Yoon J, Gleason TC, Kirkwood KA, Kilbourne AM, Gerrity M, Marder S, Biswas K, Hicks P, Davis LL, Chen P, Kelada A, Huang GD, Lawrence DD, LeGwin M, Zisook S. The VA augmentation and switching treatments for improving depression outcomes (VAST-D) study: Rationale and design considerations. Psychiatry Res. 2015 Oct 30;229(3):760-70. doi: 10.1016/j.psychres.2015.08.005. Epub 2015 Aug 6.

    PubMed 26279130

  • Zisook S, Tal I, Weingart K, Hicks P, Davis LL, Chen P, Yoon J, Johnson GR, Vertrees JE, Rao S, Pilkinton PD, Wilcox JA, Sapra M, Iranmanesh A, Huang GD, Mohamed S. Characteristics of U.S. Veteran Patients with Major Depressive Disorder who require "next-step" treatments: A VAST-D report. J Affect Disord. 2016 Dec;206:232-240. doi: 10.1016/j.jad.2016.07.023. Epub 2016 Jul 26.

    PubMed 27479536

  • Mohamed S, Johnson GR, Chen P, Hicks PB, Davis LL, Yoon J, Gleason TC, Vertrees JE, Weingart K, Tal I, Scrymgeour A, Lawrence DD, Planeta B, Thase ME, Huang GD, Zisook S; and the VAST-D Investigators; Rao SD, Pilkinton PD, Wilcox JA, Iranmanesh A, Sapra M, Jurjus G, Michalets JP, Aslam M, Beresford T, Anderson KD, Fernando R, Ramaswamy S, Kasckow J, Westermeyer J, Yoon G, D'Souza DC, Larson G, Anderson WG, Klatt M, Fareed A, Thompson SI, Carrera CJ, Williams SS, Juergens TM, Albers LJ, Nasdahl CS, Villarreal G, Winston JL, Nogues CA, Connolly KR, Tapp A, Jones KA, Khatkhate G, Marri S, Suppes T, LaMotte J, Hurley R, Mayeda AR, Niculescu AB 3rd, Fischer BA, Loreck DJ, Rosenlicht N, Lieske S, Finkel MS, Little JT. Effect of Antidepressant Switching vs Augmentation on Remission Among Patients With Major Depressive Disorder Unresponsive to Antidepressant Treatment: The VAST-D Randomized Clinical Trial. JAMA. 2017 Jul 11;318(2):132-145. doi: 10.1001/jama.2017.8036.

    PubMed 28697253

  • Zisook S, Johnson GR, Planeta B, Mohamed S. How Does Positive Mental Health Affect Next-Step Treatment Outcomes in Treatment-Resistant Depression? A VAST-D Report. J Clin Psychopharmacol. 2025 Sep-Oct 01;45(5):421-431. doi: 10.1097/JCP.0000000000002051. Epub 2025 Jul 31.

    PubMed 40742171

  • Zisook S, Moutier CY, Rush AJ, Johnson GR, Tal I, Chen PJ, Davis LL, Hicks PB, Wilcox J, Planeta B, Lauro KW, Scrymgeour AA, Kasckow J, Mohamed S. Effect of next-step antidepressant treatment on suicidal ideation: findings from the VAST-D trial. Psychol Med. 2024 Apr;54(6):1172-1183. doi: 10.1017/S0033291723003008. Epub 2023 Oct 20.

    PubMed 37859623

  • Zisook S, Planeta B, Hicks PB, Chen P, Davis LL, Villarreal G, Sapra M, Johnson GR, Mohamed S. Childhood adversity and adulthood major depressive disorder. Gen Hosp Psychiatry. 2022 May-Jun;76:36-44. doi: 10.1016/j.genhosppsych.2022.03.008. Epub 2022 Mar 24.

    PubMed 35366613

  • Zisook S, Johnson GR, Hicks P, Chen P, Beresford T, Michalets JP, Rao S, Thase ME, Wilcox J, Sevilimedu V, Mohamed S. Continuation phase treatment outcomes for switching, combining, or augmenting strategies for treatment-resistant major depressive disorder: A VAST-D report. Depress Anxiety. 2021 Feb;38(2):185-195. doi: 10.1002/da.23114. Epub 2020 Nov 22.

    PubMed 33225492

  • Mohamed S, Johnson GR, Sevilimedu V, Rao SD, Hicks PB, Chen P, Lauro K, Jurjus G, Pilkinton P, Davis L, Wilcox JA, Iranmanesh A, Sapra M, Aslam M, Michalets J, Thase M, Zisook S; CSP#576 VAST-D Investigators. Impact of Concurrent Posttraumatic Stress Disorder on Outcomes of Antipsychotic Augmentation for Major Depressive Disorder With a Prior Failed Treatment: VAST-D Randomized Clinical Trial. J Clin Psychiatry. 2020 Jun 23;81(4):19m13038. doi: 10.4088/JCP.19m13038.

    PubMed 32603560

  • Zisook S, Johnson GR, Tal I, Hicks P, Chen P, Davis L, Thase M, Zhao Y, Vertrees J, Mohamed S. General Predictors and Moderators of Depression Remission: A VAST-D Report. Am J Psychiatry. 2019 May 1;176(5):348-357. doi: 10.1176/appi.ajp.2018.18091079. Epub 2019 Apr 5.

    PubMed 30947531

  • Yoon J, Zisook S, Park A, Johnson GR, Scrymgeour A, Mohamed S. Comparing Cost-Effectiveness of Aripiprazole Augmentation With Other "Next-Step" Depression Treatment Strategies: A Randomized Clinical Trial. J Clin Psychiatry. 2018 Dec 18;80(1):18m12294. doi: 10.4088/JCP.18m12294.

    PubMed 30695291

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Switching: Bupropion-SR, Augmenting: Antidepressant + Bupropion-SR and Augmenting: Antidepressant + Aripiprazole in people with Major Depressive Disorder, run by VA Office of Research and Development at 35 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 4 inclusion and 14 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 29 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 29 May 2018). 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?

Rate of Protocol Remission of Symptoms of Major Depressive Disorder (time frame: During acute phase (12 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 NCT01421342, which also lists 10 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 29 May 2018.

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