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Depressive EpisodePhase 2NCT03543410

A Clinical Study to Test the Effectiveness of an Investigational Drug to Treat People That Have Major Depressive Episodes When They Have Bipolar 1 Depression

A Phase 2 study testing SEP-4199 200 mg and SEP-4199 400 mg in people with Depressive Episode and Bipolar 1 Depression, run by Sumitomo Pharma America, Inc. at 87 sites in 8 countries.

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

A clinical study to test the effectiveness of an investigational drug to treat people that have major depressive episodes when they have Bipolar 1 Depression Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Depressive Episode, Bipolar 1 Depression
What is being tested?
SEP-4199 200 mg and SEP-4199 400 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
344 participants
Where
87 sitesin 8 countries
Study dates
26 Jun 2018to 23 Apr 2020
Phase
Phase 2
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

  • Subject is 18 to 65 years of age, inclusive, at the time of informed consent with bipolar I disorder, current episode depressed with or without rapid cycling disease course (≥ 4 episodes of mood disturbance but < 8 episodes in the previous 12 months) with or without psychotic features (diagnosed by DSM 5 criteria, and confirmed by the SCID 5 CT). The current episode of major depression associated with bipolar I disorder must be confirmed by the Investigator and noted in the source records.
  • Subject provides written informed consent and is willing and able to comply with the protocol in the opinion of the investigator.
  • Subject or legally acceptable representative must possess an educational level and degree of understanding of English or the local language that enables them to communicate suitably with the Investigator and the study coordinator.
  • Subject must have a lifetime history of at least one bipolar manic or mixed manic episode. It is strongly recommended that a reliable informant (e.g., family member or caregiver) be available to confirm this history.
  • Subject's current major depressive episode is ≥ 4 weeks and less than 12 months in duration at Screening.
  • Subject has a MADRS total score ≥ 22 at both Screening and Baseline.
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  • Subject has a YMRS total score ≤ 12 at Screening.
  • Female subjects of childbearing potential must have a negative serum ß-hCG test at Screening.
  • Females who participate in this study must be . one of the following:
  • unable to become pregnant (e.g., postmenopausal, surgically sterile, etc.) -OR-
  • Practicing abstinence or part of an abstinent lifestyle
  • using and willing to continue using a highly effective form of birth control for at least 28 days prior to administration of the first dose of study drug, during the treatment period, and 2 months after completion or premature discontinuation from the study drug.
  • Male subjects with partners of child bearing potential must be practicing abstinence, part of an abstinent life style or using protocol-specified methods of birth control. See Section 10.4 for further information on acceptable methods of birth control.
  • Subject is in good physical health on the basis of medical history, physical examination, and laboratory screening.
  • Subjects with type 2 diabetes are eligible for study inclusion only if all of the following conditions are met within 30 days prior to Screening:
  • Subject's random screening glucose is < 200 mg/dL (11.1 mmol/L).
  • Subject's Hemoglobin A1c (HbA1c) ≤ 7.0%.
  • If a subject is currently being treated with oral anti-diabetic medication(s), the dose must have been stable for at least 30 days prior to screening. Such medication may be adjusted or discontinued during the study, as clinically indicated.
  • Subject has not required hospitalization for diabetes or related complications in the past 12 months.
  • Note: Subjects with type 2 diabetes that is newly diagnosed during screening are ineligible for the study.
  • Subject who requires concomitant medication treatment with the following agents may be included if they have been on stable doses for the specified times: 1) oral hypoglycemics must be stabilized for at least 30 days prior to baseline; 2) thyroid hormone replacement must be stable for at least 90 days prior to baseline; 3) anti hypertensive agents must be stable for at least 30 days prior to baseline. The subject's medical condition should be deemed clinically stable following consultation with the Medical Monitor as needed.

Who cannot join

  • Subject has a lifelong history or presence of symptoms consistent with a major psychiatric disorder other than bipolar I disorder as defined by DSM 5. Exclusionary disorders include but are not limited to moderate to severe alcohol use disorder (within past 12 months), substance use disorder (other than nicotine or caffeine) within past 12 months, bipolar II disorder, schizoaffective disorder, obsessive compulsive disorder, posttraumatic stress disorder.
  • Subject demonstrates a decrease (improvement) of ≥ 25% in MADRS total score from Screening to Baseline, or subject's MADRS total score is < 22 at Baseline.
  • Subject has received treatment with antidepressants within 3 days of randomization, fluoxetine at any time within 28 days, an MAO inhibitor within 21 days or clozapine within 120 days. All other psychotropic medications with the exceptions of lorazepam, temazepam,eszopiclone, zopiclone, zolpidem and zolpidem CR require 3 days minimum washout. Depot neuroleptics must be discontinued at least one treatment cycle prior to randomization.
  • Subject has suspected/confirmed Borderline Personality Disorder
  • Subject currently has a clinically significant neurological, metabolic (including type 1 diabetes), hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, and/or urological disorder such as unstable angina, congestive heart failure (uncontrolled), or central nervous system (CNS) infection that would pose a risk to the subject if they were to participate in the study or that might confound the results of the study. Subjects with a known history of HIV seropositivity will be excluded.
  • Note: Active medical conditions that are minor or well-controlled are not exclusionary if they do not affect risk to the subject or the study results. In cases in which the impact of the condition upon risk to the subject or study results is unclear, the Medical Monitor should be consulted. Any subject with a known cardiovascular disease or condition (even if under control) must be discussed with the Medical Monitor before being randomized in the study.
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  • Subject has evidence of any chronic organic disease of the CNS such as tumors, inflammation, active (or history of) seizure disorder, vascular disorder, Parkinson's disease, Alzheimer's disease or other forms of dementia, myasthenia gravis, or other degenerative processes. In addition, subjects must not have a history of intellectual disability or persistent neurological symptoms attributable to serious head injury. Past history of febrile seizure, is not exclusionary.
  • Subject has a history of malignancy < 5 years prior to signing the informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. Subjects with pituitary tumors of any duration are excluded.
  • Subject demonstrates evidence of acute hepatitis, clinically significant chronic hepatitis, or evidence of clinically significant impaired hepatic function through clinical and laboratory evaluation (use screening values for laboratory evaluation). Subject has a history of stomach or intestinal surgery or any other condition that could interfere with absorption, distribution, metabolism, or excretion of medications.
  • Subject has knowledge of any kind of cardiovascular disorder/condition known to increase the possibility of QT prolongation or history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome or Brugada Syndrome) or cardiac conduction disorders, or requires treatment with an antiarrhythmic medication.
  • Subject has family history of QTc prolongation or of unexplainable sudden death at < 50 years of age.
  • Abnormal 12 lead ECG at Screening, including:
  • QTcF > 450 ms (male subjects) or > 470 ms (female subjects)
  • QRS > 110 ms
  • PR > 200 ms
  • Second- or third-degree atrioventricular block
  • Any rhythm other than sinus rhythm, which is interpreted by the Investigator to be clinically significant
  • Subject has a history of neuroleptic malignant syndrome (NMS).
  • Subject exhibits evidence of severe tardive dyskinesia, severe dystonia, or any other severe movement disorder. Severity is to be determined by the investigator.
  • Subject has been diagnosed with type 1 diabetes, or insulin-dependent diabetics.
  • Subject who has any abnormal laboratory parameter at screening that indicates a clinically significant medical condition as determined by the investigator. Subjects with fasting blood glucose at screening ≥ 126 mg/dL (7.0 mmol/L) will be excluded from the study. Subjects with fasting blood glucose from 100-125 mg/dL (5.6-6.9 mmol/L) may enter the study based on the approval of the Medical Monitor. Subjects with HbA1c > 7.0% will be excluded. Subjects who are found to have been non-fasting at Screening may be allowed if their blood glucose is < 200 mg/dL. Subjects with random (nonfasting) blood glucose at screening ≥ 200 mg/dL (11.1 mmol/L) must be retested in a fasted state. Subjects with HbA1c > 7.0% will be excluded.
  • Subject has a prolactin concentration > 100 ng/mL at screening or have a history of pituitary adenoma.
  • Subject has a body mass index (BMI) ≥ 40 or < 18 kg/m2.
  • Subject has a history of non-response to an adequate (6-week) trial of three or more antidepressants (with or without mood stabilizers) during the current episode.
  • Subject is considered by the Investigator to be at imminent risk of suicide or injury to self, others, or answers "yes" to "Suicidal Ideation" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS assessment at the Screening visit (in the past month [30 days]) or Baseline.
  • Subject tests positive for drugs of abuse at screening or baseline. In the event a subject tests positive for cannabinoids (tetrahydrocannabinol), the investigator will evaluate the subject's ability to abstain from cannabis during the study. This information will be discussed with the Medical Monitor for study enrollment consideration.
  • Subject has a history of hypersensitivity to more than two distinct chemical classes of drug (e.g., sulfas and penicillins).
  • Subjects have received depot neuroleptics unless the last injection was at least one treatment cycle before randomization.
  • Subject requires treatment with a drug that consistently prolongs the QTc interval
  • Subject has received ECT within 90 days prior to randomization or is expected to require ECT during the study course.
  • Subject is currently participating, or has participated in a study with an investigational or marketed compound or device within 6 months prior to signing the informed consent, or has participated in 3 or more studies within 18 months prior to signing the informed consent.

Trial locations and contacts

87 sites in 8 countries.

87 sites in 8 countries

Japan35 sites

  • Fukuoka University Hospital

    Fukuoka

  • Hatakeyama Clinic, Department of Psychiatry

    Fukuoka

  • Hiro Mental Clinic, Department of Psychiatry

    Fukuoka

  • Kokura Mental Clinic

    Fukuoka

  • Kuramitsu Hospital, Department of Psychiatry

    Fukuoka

  • Shinseikai Kaku Mental Clinic, Department of Psychiatry

    Fukuoka

  • Someikai Kanagami Clinic, Department of Psychiatry

    Fukuoka

  • Jisenkai Nanko Psychiatric Institute, Department of Psychiatry

    Fukushima

  • Takahashi Psychiatric Clinic

    Hyōgo

  • Azamino Mental clinic, Department of Psychiatry

    Kanagawa

  • Medical Corporation Seishinkai Kishiro Mental Clinic, Department of Psychiatry

    Kanagawa

  • Musashikosugi J. Kokorono Clinic

    Kanagawa

  • Yokohama Onoecho Clinic, Department of Psychiatry

    Kanagawa

  • Yutaka Clinic

    Kanagawa

  • SagaArashiyama / Tanaka Clinic, Department of Psychiatry

    Kyoto

  • Minami-aoyama Anique Street Clinic, Department of Psychiatry

    Minato-Ku, Tokyo

  • Clinic Sophia

    Okayama

  • Nagaokai Neyagawa Sanitorium

    Osaka, 572-0854

  • Asakayama Hospital

    Osaka

  • Koshokai Ainhanazono Hospital

    Osaka

  • Osaka Institute of Clinical Psychiatry Shin-abuyama Hospital

    Osaka

  • Etoh Mental Clinic Meguro, Department of Psychiatry

    Tokyo

  • Himorogi Psychiatric Institute, Department of Psychiatry

    Tokyo

  • JCHO Yokyo Shinjuku Medical Center

    Tokyo

  • Jisenkai Hozumi Himorogi Clinic, Department of Psychiatry

    Tokyo

  • Maynds Tower Mental Clinic, Department of Psychiatry

    Tokyo

  • Nishi-shinjuku Concieria Clnic

    Tokyo

  • Ohwa Mental clinic, Department of Psychiatry

    Tokyo

  • Sangenjaya Nakamura Mental Clinic, Department of Psychiatry

    Tokyo

  • Sangenjaya Neurology-Psychosomatic Clinic, Department of Psychiatry

    Tokyo

  • Senzoku Psychosomatic Clinic, Department of Psychiatry

    Tokyo

  • Shinjuku Research Park Clinic

    Tokyo

  • Tamaki Clinic, Department of Psychiatry

    Tokyo

  • Uguisudani Mental Clinic, Department of Psychiatry

    Tokyo

  • Yoyogi Mental Clinic

    Tokyo

Other trials in Japan

Russia10 sites

  • Lipetsk regional psychoneurological hospital

    Lipetsk, 398007

  • State Budgetary Institution of Healthare of the City of Moscow "Psychiatric clinical Hospital #4 n.a. P.B. Gannushkin of the Department of Healthcare of the City o Moscow" Branch "Psychiatric hospital n.a. V.A. Gilyarovsky"

    Moscow, 107076

  • State Budgetary Institution of Healthcare of Nizhniy Novgorod region "Clinical Psychiatric Hospital #1 of Nizhniy Novgorod"

    Nizhny Novgorod, 603155

  • Budgetary Institution of Healthcare of Omsk region "Clinical Psychiatric Hospital named after N.N. Solodnikov"

    Omsk, 644070

  • Limited Liability Company "Treatment and Rehabilitational Scientific Center Phoenix"

    Rostov-on-Don, 344000

  • Saint Petersburg State Institution of Healthcare "Psychiatric Hospital of Sain Nikolai hudotvorets "

    Saint Petersburg, 190121

  • Federal State Budgetary Institution "National Medical Research Centre of psychiatry and nuerology named after V.M. Bekhterev" of the Ministry of Healthcare of the Russian Federation, department #12

    Saint Petersburg, 192019

  • Stain Petersburg State Budgetary Institution of Healthcare "Psychoneurological Dispensary #1"

    Saint Petersburg, 199106

  • State Institution of Healtcare "Regional Clinical Psychiatric Hospital of Saint Sofia"

    Saratov, 410060

  • Limited Liability Company "Clinic StoLet"

    Tomsk, 634009

Other trials in Russia

Ukraine10 sites

  • Regional Psychoneurological Hospital #3, Department of Neurosis and Borderline States # 8

    Ivano-Frankivsk, 76011

  • State Institution Institue of Neurology, Psychiatry and Narcology of NAMS of Ukraine, Unit of Emergency sychiatry and Narcology

    Kharkiv, 61068

  • State Institution Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine, Unit of Borderline Psychiatry

    Kharkiv, 61068

  • CI Kherson Regional Psychiatric Hospital of Kherson Regional Council, Male Dep of Psychiatry #3, Female Dep of Psychiatry #10

    Kherson, 73488

  • Communal Institution (CI) of Kyiv Regional Council regional Psychiatric and Narcological Medical Assocation, Dep #10 (male), Dep #2 (female)

    Kyiv, 08631

  • Communal Institution Odesa regional Medical Center of Mental Health, Dep #6 (Male), Dep #12 (Female)

    Odesa, 65006

  • Communal Institution Odesa Regional Psychiatric Hospital #2, Department #14 (female), Department #16 (male)

    Odesa, 67513

  • Communal Institution Cherkasy regional Psychiatric Hospital of Cherkasy Regional Council, Female Department #11, Male Department #12

    Smila, 20708

  • Transcarpathian Regional Narcological Dispensary, Department of Psychiatry

    Uzhhorod, 88000

  • communal Institution Acad. O.I. Yushchenko Vinnytsia Regional Psychoneurological hosital, Male Deparmtent #14, Female Department #15, Vinnytsia M.I. Pyrogov National Medical University, Chair of Psychiatry, Narcology and Psychotherapy with the Course of P

    Vinnytsia, 21005

Other trials in Ukraine

United States7 sites

  • Atlanta Center for Medical Research

    Atlanta, Georgia, 30331

  • CNS Research Science, Inc.

    Cerritos, California, 90703

  • Eastside Therapeutic Resource dba Core Clinical Research

    Everett, Washington, 98201

  • Collaborative Neuroscience Network, LLC

    Garden Grove, California, 92845

  • Clinical Neuroscience Solutions, Inc.

    Jacksonville, Florida, 32256

  • Clinical Neuroscience Solutions, Inc.

    Orlando, Florida, 32801

  • Artemis Insitute for Clinical Research

    San Diego, California, 92103

Other trials in United States

Poland7 sites

  • Przychodnia Srodmiescie Sp. z.o.o.

    Bydgoszcz, 85-080

  • Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS

    Leszno, 64-100

  • Specjalistyczna Praktyka Lekarska Marek Domanski

    Lublin

  • Filip Rybakowski Specjalistyczna Praktka Lekarska

    Poznan, 60-744

  • Poradnia Zdrowia Psychicznego "Syntonia"

    Pruszcz Gdański, 83-000

  • Gabinet Lekarski Torunskie Centrum PsychiatriI NEUROMED

    Torun, 87-100

  • Osrodek Badan Klinicznych Clinsante Spolka Cywilna

    Torun, 87-100

Other trials in Poland

Serbia7 sites

  • Bel Medic General Hospital

    Belgrade, 11000

  • Clinical Center "Dr. Dragisa Misovic-Dedinje"

    Belgrade, 11000

  • Clinical Center of Serbia

    Belgrade, 11000

  • General Hospital Euromedik

    Belgrade, 11000

  • Institute of Mental Health

    Belgrade, 11000

  • Special Hospital for Psychiatric Diseases "Kovin"

    Kovin, 26220

  • Clinical Center Kragujevac

    Kragujevac, 34000

Other trials in Serbia

Bulgaria6 sites

  • Mental Health Centre -Prof. Dr. Ivan Temkov - Burgas EOOD

    Burgas, 8000

  • State Psychiatric Hospital-Kardzhali

    Kardzhali, 6600

  • MHAT-Dr. Hristo Stambolski EOOD, Department of Psychiatry

    Kazanlak, 6100

  • Mental Health Center - Ruse EOOD

    Rousse, 7003

  • Neli Nikolova Todorova, MD ,State Psychatric Hospital - s. Tsarev brod

    Shumen, 9747

  • Mental Health Center - Sofia EOOD

    Sofia, 1202

Other trials in Bulgaria

Slovakia5 sites

  • Vavrusova Consulting s.r.o. Psychiatricka ambulancia

    Bratislava, 85101

  • Investa spol. s.r.o., Kosice Psychiatricka ambulancia

    Košice, 04001

  • Psycholine s.r.0. Psychiatricka ambulancia

    Rimavská Sobota, 97901

  • Centrum zdravia R.B.K. Psychiatricka ambulancia

    Svidník, 08901

  • Crystal Comfort s.r.o. Psychiatricka ambulancia

    Vranov nad Topľou, 09301

Other trials in Slovakia

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of SEP-4199 for the Treatment of Major Depressive Episode Associated With Bipolar I Disorder (Bipolar I Depression)

A clinical study to test the effectiveness of an investigational drug to treat people that have major depressive episodes when they have Bipolar 1 Depression

Read the detailed description

This is a randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study designed to evaluate the efficacy, safety, and tolerability of treatment with SEP-4199 monotherapy given as 200 mg/day or 400 mg/day compared with placebo for the treatment of major depressive episodes associated with bipolar I disorder (bipolar I depression).

Being tested
SEP-4199 200 mg, SEP-4199 400 mg, Placebo
Keywords
Depression, Depressive episode, Bipolar, Bipolar 1, Bipolar 1 depression
Medical subject headings
Depression

What participants receive

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

  • SEP-4199 200 mgDrug

    SEP-4199 200 mg/day (supplied in two 100mg tablets)

  • SEP-4199 400 mgDrug

    SEP-4199 400 mg/day (supplied in two 200mg tablets

  • PlaceboDrug

    Placebo (supplied in two tablets/day)

Study groups in NCT03543410
Study groupRoleWhat they receive
SEP-4199 200 mgExperimentalSEP-4199 200 mg/day (supplied in two 100mg tablets)
Receives: Drug: SEP-4199 200 mg
SEP-4199 400 mgExperimentalSEP-4199 400 mg/day (supplied in two 200mg tablets)
Receives: Drug: SEP-4199 400 mg
PlaceboPlacebo comparatorPlacebo (supplied in two tablets/day
Receives: Drug: Placebo

What is being measured

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

  1. Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6

    MADRS is a clinician-rated assessment of the subject's level of depression. The measure contains 10 items that measure apparent and reported sadness, inner tension, reduced sleep and appetite, difficulty concentrating, lassitude, inability to feel, and pessimistic and suicidal thoughts, each ranging from 0 to 6. The MADRS total score ranges from 0 to 60, with higher scores indicating increased depressive symptoms

    Measured: 6 Weeks

Secondary outcomes (1)

  1. Change From Baseline in Global Severity Assessed by the Clinical Global Impressions - Severity: Bipolar Version (CGI-BP-S) Score (Depression) at Week 6

    Clinical Global Impressions - Severity: Bipolar Version (CGI-BP-S) score (depression) is a single value, clinician-rated assessment of illness severity, and 7-point scale with range from 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill subjects. A higher score is associated with greater illness severity.

    Measured: 6 Weeks

Timeline

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

  1. First posted1 Jun 2018
  2. Study start26 Jun 2018
  3. Primary completion23 Apr 2020
  4. Study completion23 Apr 2020

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
344 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03543410
Sponsor's protocol ID
SEP380-201
Other IDs
2018-000103-16, 2018
Status last verified
Apr 2023
First submitted
21 May 2018
Last updated
18 May 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: IPD for this study may be made available upon request via the Vivli Center for Global Clinical Research Data website.

Publications

  • Hopkins SC, Tomioka S, Szabo ST, Koblan KS. A clinical trial inclusion criteria to enrich for patients presenting with canonical symptom structure in bipolar depression. Contemp Clin Trials. 2024 Oct;145:107644. doi: 10.1016/j.cct.2024.107644. Epub 2024 Aug 3.

    PubMed 39098761

  • Hopkins SC, Wilkinson S, Corriveau TJ, Nishikawa H, Nakamichi K, Loebel A, Koblan KS. Discovery of Nonracemic Amisulpride to Maximize Benefit/Risk of 5-HT7 and D2 Receptor Antagonism for the Treatment of Mood Disorders. Clin Pharmacol Ther. 2021 Sep;110(3):808-815. doi: 10.1002/cpt.2282. Epub 2021 Jun 12.

    PubMed 33961287

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SEP-4199 200 mg and SEP-4199 400 mg in people with Depressive Episode and Bipolar 1 Depression, run by Sumitomo Pharma America, Inc. at 87 sites in 8 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 21 inclusion and 31 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 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 87 sites in Japan, Russia, Ukraine, United States, Poland and 3 more countries. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 18 May 2023). 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?

Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6 (time frame: 6 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 NCT03543410, 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 18 May 2023.

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