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CompletedNCT04521478

Safety study of BI 1358894 in depression

This study is completed in the United States, in Australia, in France, .... It is testing BI 1358894 for depression.

DepressionDrugFrom 18 Years to 65 Years

The public registry lists this study as not currently recruiting. This page remains available for information. Check the official record for the latest status and explore other recruiting studies.

Then choose your country and confirm availability with each study site.

In plain English

Key information made simple

What is this study testing?

This study is testing whether BI 1358894 may be useful for adults experiencing depression.

What would participation involve?

Participants may receive BI 1358894, attend study visits with the research team. The protocol may also involve randomization, placebo, or a comparison group. The registry lists locations in Argentina, in Australia, and in Bulgaria.

Who is it mainly for?

This study appears to be mainly for adults with depression.

What should you check before joining?

Ask about the dose, safety monitoring, and possible side effects, whether there is placebo, randomization, or a comparison group, how many visits or travel steps are needed, the exact eligibility criteria.

Your next step

Check the study details

Check the official source, then confirm these points with the research team.

View official study record (opens in a new tab)
  • Recruitment and eligibility

    Is a site open, and who can take part?

  • Visits and time

    Where are visits, can any be remote, and how much time is needed?

  • Costs and support

    What costs, reimbursement or compensation apply?

Before joining

Questions to ask before joining

Study clarity

Things to check before joining

Study start dateStarted: November 20, 2020
Recruitment status
Completed
Enrollment listed in the registry
389
Sponsor
Boehringer Ingelheim
Sponsor type
Unknown or unclear
Study type
Drug
Intervention type
Medication / drug
Study phase
Phase 2Usually explores whether the intervention may work, while continuing to monitor safety.
Locations
United States, Australia, France, ...
Age range
From 18 Years to 65 Years
Official registry ID
NCT04521478
Official title
A Phase II, 6-week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel Group Trial With a Quetiapine Arm to Evaluate the Efficacy, Tolerability and Safety of Oral BI 1358894 in Patients With Major Depressive Disorder With Inadequate Response to Antidepressants.

Check recruitment and locations

Recruitment checked against the registry by HopeStage on . Registry information can change. Always confirm availability with the research team.

View official study record (opens in a new tab)

The overall study status can differ from each site's status. Open a country to see its locations and their registry status.

Argentina · 8 sites
  • Fundación para el Estudio y Tratamiento de las Enfermedades Mentales (FETEM)
    CABA
    Site status: Not listed — confirm with the team
  • CEN (Centro Especializado Neurociencias)
    Córdoba
    Site status: Not listed — confirm with the team
  • Instituto DAMIC - Fundacion Rusculleda
    Córdoba
    Site status: Not listed — confirm with the team
  • CENPIA-Centro de Estudios Neuropsiquiátricos y Psicológicos Integral Ambulatorio
    La Plata
    Site status: Not listed — confirm with the team
  • Clinica Privada de Salud Mental Santa Teresa de Avila
    La Plata
    Site status: Not listed — confirm with the team
  • Instituto de Neurociencias San Agustín
    La Plata
    Site status: Not listed — confirm with the team
  • Instituto Médico de la Fundación Estudios Clínicos
    Rosario
    Site status: Not listed — confirm with the team
  • Centro de Investigacion y Asistencia en Psiquiatria (CIAP)
    Rosario
    Site status: Not listed — confirm with the team
Australia · 4 sites
  • Griffith Health
    Southport, Queensland
    Site status: Not listed — confirm with the team
  • Peninsula Therapeutic and Research Group
    Frankston, Victoria
    Site status: Not listed — confirm with the team
  • Albert Road Clinic
    Melbourne, Victoria
    Site status: Not listed — confirm with the team
  • Monash Alfred Psychiatry Research Centre
    Melbourne, Victoria
    Site status: Not listed — confirm with the team
Bulgaria · 3 sites
  • Mental Health Center "Prof. Dr. Ivan Temkov - Burgas" EOOD
    Burgas
    Site status: Not listed — confirm with the team
  • Filipopolis Ambulatory for Group Practice for Specialized Care in Psychiatry
    Plovdiv
    Site status: Not listed — confirm with the team
  • Medical Center Intermedica Ltd.
    Sofia
    Site status: Not listed — confirm with the team
Canada · 4 sites
  • University of Calgary
    Calgary, Alberta
    Site status: Not listed — confirm with the team
  • OCT Research ULC
    Kelowna, British Columbia
    Site status: Not listed — confirm with the team
  • Braxia Scientific Corp. (CRTCE Mississauga)
    Mississauga, Ontario
    Site status: Not listed — confirm with the team
  • Centre for Addiction and Mental Health (CAMH)
    Toronto, Ontario
    Site status: Not listed — confirm with the team
Czechia · 7 sites
  • Neuropsychiatry, s.r.o.
    Hradec Králové
    Site status: Not listed — confirm with the team
  • Clinical Research Foundation s.r.o
    Kladno
    Site status: Not listed — confirm with the team
  • MP Meditrine s.r.o.
    Ostrava
    Site status: Not listed — confirm with the team
  • A-SHINE s.r.o
    Pilsen
    Site status: Not listed — confirm with the team
  • Clintrial s.r.o.
    Prague
    Site status: Not listed — confirm with the team
  • AD71 s.r.o.
    Prague
    Site status: Not listed — confirm with the team
  • INEP medical s.r.o.
    Prague
    Site status: Not listed — confirm with the team
France · 9 sites
  • HOP Dijon-Bourgogne
    Dijon
    Site status: Not listed — confirm with the team
  • CAB Médical Psyché
    Douai
    Site status: Not listed — confirm with the team
  • CAB Ambroise Paré
    Élancourt
    Site status: Not listed — confirm with the team
  • HOP la Colombière
    Montpellier
    Site status: Not listed — confirm with the team
  • HOP Saint-Jacques
    Nantes
    Site status: Not listed — confirm with the team
  • HOP Pasteur
    Nice
    Site status: Not listed — confirm with the team
  • HOP Carémeau
    Nîmes
    Site status: Not listed — confirm with the team
  • CTR Psychiatrique Universitaire
    Saint-Cyr-sur-Loire
    Site status: Not listed — confirm with the team
  • HOP Purpan
    Toulouse
    Site status: Not listed — confirm with the team
Germany · 6 sites
  • Zentrum für klinische Forschung Dr. med. I. Schöll GmbH
    Bad Homburg
    Site status: Not listed — confirm with the team
  • Universitätsklinikum Frankfurt
    Frankfurt am Main
    Site status: Not listed — confirm with the team
  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
    Mainz
    Site status: Not listed — confirm with the team
  • Zentralinstitut für seelische Gesundheit
    Mannheim
    Site status: Not listed — confirm with the team
  • Praxis für Psychiatrie und Psychotherapie
    Stralsund
    Site status: Not listed — confirm with the team
  • Studienzentrum Nord-West
    Westerstede
    Site status: Not listed — confirm with the team
Hungary · 3 sites
  • Obuda Health Center
    Budapest
    Site status: Not listed — confirm with the team
  • Semmelweis University
    Budapest
    Site status: Not listed — confirm with the team
  • Bugat Pal Hospital, Gyongyos
    Gyöngyös
    Site status: Not listed — confirm with the team
Japan · 20 sites
  • National Center for Global Health and Medicine Kohnodai Hospital
    Chiba, Ichikawa
    Site status: Not listed — confirm with the team
  • Kaku Mental Clinic
    Fukuoka, Fukuoka
    Site status: Not listed — confirm with the team
  • Fukuoka University Hospital
    Fukuoka, Fukuoka
    Site status: Not listed — confirm with the team
  • Kuramitsu Hospital
    Fukuoka, Fukuoka
    Site status: Not listed — confirm with the team
  • Hokudai-dori Mental Health Clinic
    Hokkaido, Sapporo
    Site status: Not listed — confirm with the team
  • Arai Clinic
    Hyogo, Amagasaki
    Site status: Not listed — confirm with the team
  • Tatsuta Clinic
    Hyogo, Kobe
    Site status: Not listed — confirm with the team
  • Kishiro Mental Clinic
    Kanagawa, Kawasaki
    Site status: Not listed — confirm with the team
  • Yutaka Clinic
    Kanagawa,Sagamihara
    Site status: Not listed — confirm with the team
  • Yuge Neuropsychiatric Hospital
    Kumamoto, Kumamoto
    Site status: Not listed — confirm with the team
  • Arata Clinic
    Nagasaki, Nagasaki
    Site status: Not listed — confirm with the team
  • Nara Medical University Hospital
    Nara, Kashihara
    Site status: Not listed — confirm with the team
  • Rainbow and Sea Hospital
    Saga, Karatsu
    Site status: Not listed — confirm with the team
  • Inuo Hospital
    Saga, Tosu
    Site status: Not listed — confirm with the team
  • National Center of Neurology and Psychiatry
    Tokyo, Kodaira
    Site status: Not listed — confirm with the team
  • Tamachi mita cocoromi Clinic
    Tokyo, Minato-ku
    Site status: Not listed — confirm with the team
  • Sancha Mental Clinic
    Tokyo, Setagaya-ku
    Site status: Not listed — confirm with the team
  • Maynds Tower Mental Clinic
    Tokyo, Shibuya-ku
    Site status: Not listed — confirm with the team
  • Ichigaya Himorogi Clinic
    Tokyo, Shinjuku-ku
    Site status: Not listed — confirm with the team
  • Ohwa Mental Clinic
    Tokyo, Toshima-ku
    Site status: Not listed — confirm with the team
Poland · 6 sites
  • Synexus Polska SCM Sp. z o.o. Gdansku, Gdansk
    Gdansk
    Site status: Not listed — confirm with the team
  • Synexus Lodz Medical Center
    Lodz
    Site status: Not listed — confirm with the team
  • Specialist Psychiatric Healthcare Centre in Lodz
    Lodz
    Site status: Not listed — confirm with the team
  • Clinical Best Solutions
    Lublin
    Site status: Not listed — confirm with the team
  • Centrum Medyczne "Luxmed" Sp. z o.o.
    Lublin
    Site status: Not listed — confirm with the team
  • Synexus Poland, Branch in Poznan
    Poznan
    Site status: Not listed — confirm with the team
Russia · 7 sites
  • Federal State Budget Institution "Mental Health Research Center"
    Moscow
    Site status: Not listed — confirm with the team
  • SBI of HC "Z. P. Solovyov Scientific&pract psychoneurolog.Cent"
    Moscow
    Site status: Not listed — confirm with the team
  • SBHI "Psychiatric Hospital #1 P.P.Kashchenko"
    Saint Petersburg
    Site status: Not listed — confirm with the team
  • FSBI Bekhterev Net.Med.Res.Cen.of Psych&Neuro
    Saint Petersburg
    Site status: Not listed — confirm with the team
  • LLC "MK-Med"
    Saint Petersburg
    Site status: Not listed — confirm with the team
  • SHI "Reg.Clin.Psychiatric Hosp.of Saint Sophia"
    Saratov
    Site status: Not listed — confirm with the team
  • FSBEI of HE Smolensk State Medical University
    Smolensk
    Site status: Not listed — confirm with the team
Slovakia · 8 sites
  • MUDr. Beata Dupejová
    Banská Bystrica
    Site status: Not listed — confirm with the team
  • J & J SMART, s.r.o., psychiatric clinic
    Bratislava
    Site status: Not listed — confirm with the team
  • MENTUM s.r.o.
    Bratislava
    Site status: Not listed — confirm with the team
  • EPAMED s.r.o.
    Košice
    Site status: Not listed — confirm with the team
  • Psychiatricka klinika I.UN L. Pasteura
    Košice
    Site status: Not listed — confirm with the team
  • CENTRUM ZDRAVIA R.B.K, s.r.o., psychiatric clinic
    Svidník
    Site status: Not listed — confirm with the team
  • Pro mente sana s.r.o., Psychiatric clinic
    Trenčín
    Site status: Not listed — confirm with the team
  • Crystal Comfort s.r.o
    Vranov nad Topľou
    Site status: Not listed — confirm with the team
Spain · 6 sites
  • Hospital Universitario Fundación Alcorcón
    Alcorcón
    Site status: Not listed — confirm with the team
  • Hestia Palau
    Barcelona
    Site status: Not listed — confirm with the team
  • Hospital Clínic de Barcelona
    Barcelona
    Site status: Not listed — confirm with the team
  • Hospital Jerez de la Frontera
    Jerez de la Frontera
    Site status: Not listed — confirm with the team
  • Hospital Ramón y Cajal
    Madrid
    Site status: Not listed — confirm with the team
  • Centro de Salud de San Juan
    Salamanca
    Site status: Not listed — confirm with the team
United States · 29 sites
  • University of Alabama at Birmingham
    Birmingham, Alabama
    Site status: Not listed — confirm with the team
  • Collaborative Neuroscience Network, LLC (CNS)
    Garden Grove, California
    Site status: Not listed — confirm with the team
  • Alliance Research
    Long Beach, California
    Site status: Not listed — confirm with the team
  • Asclepes Research Centers
    Sherman Oaks, California
    Site status: Not listed — confirm with the team
  • California Neuroscience Research
    Sherman Oaks, California
    Site status: Not listed — confirm with the team
  • Schuster Medical Research Institute
    Sherman Oaks, California
    Site status: Not listed — confirm with the team
  • Viking Clinical Research, Ltd.
    Temecula, California
    Site status: Not listed — confirm with the team
  • Collaborative Neuroscience Research, LLC
    Torrance, California
    Site status: Not listed — confirm with the team
  • Mountain Mind. LLC
    Denver, Colorado
    Site status: Not listed — confirm with the team
  • CT Clinical Research
    Cromwell, Connecticut
    Site status: Not listed — confirm with the team
  • Institute of Living
    Hartford, Connecticut
    Site status: Not listed — confirm with the team
  • Gulf Coast Clinical Research Center
    Fort Myers, Florida
    Site status: Not listed — confirm with the team
  • Sarkis Clinical Trials
    Gainesville, Florida
    Site status: Not listed — confirm with the team
  • Clinical Neuroscience Solutions, Inc
    Jacksonville, Florida
    Site status: Not listed — confirm with the team
  • Optimus U Corporation
    Miami, Florida
    Site status: Not listed — confirm with the team
  • Advanced Discovery Research LLC
    Atlanta, Georgia
    Site status: Not listed — confirm with the team
  • Atlanta Center
    Atlanta, Georgia
    Site status: Not listed — confirm with the team
  • Chicago Research Center, Incorporated
    Chicago, Illinois
    Site status: Not listed — confirm with the team
  • University of Kansas School of Medicine-Wichita
    Wichita, Kansas
    Site status: Not listed — confirm with the team
  • Precise Research Centers
    Flowood, Mississippi
    Site status: Not listed — confirm with the team
  • Psychiatric Care and Research Center
    O'Fallon, Missouri
    Site status: Not listed — confirm with the team
  • Center For Emotional Fitness
    Cherry Hill, New Jersey
    Site status: Not listed — confirm with the team
  • Hassman Research Institute
    Marlton, New Jersey
    Site status: Not listed — confirm with the team
  • Synexus Clinical Research US, Inc.
    New York, New York
    Site status: Not listed — confirm with the team
  • University of Cincinnati
    Cincinnati, Ohio
    Site status: Not listed — confirm with the team
  • The Ohio State University Wexner Medical Center
    Columbus, Ohio
    Site status: Not listed — confirm with the team
  • Lehigh Center for Clinical Research
    Allentown, Pennsylvania
    Site status: Not listed — confirm with the team
  • Global Medical Institutes, LLC, Scranton Medical Institute
    Moosic, Pennsylvania
    Site status: Not listed — confirm with the team
  • Core Clinical Research
    Everett, Washington
    Site status: Not listed — confirm with the team

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Study ID: NCT04521478. We help you review the study, but cannot decide medical eligibility.
In practice

For you

Participation may contribute to research. Personal benefit is not guaranteed.

Ask the research team to explain the activities, time commitment, and follow-up involved.

Study sites are listed. Confirm the relevant site and any travel before making plans.

Important

Not medical advice

Information from public sources. Are you the study sponsor? Contact us to update this page: hi@hopestage.com

FAQ

Questions about this study

What is this study trying to understand?

This study is exploring medication or study treatment for people with depression. Participants may complete study visits, assessments, or follow-up activities defined by the research team. Direct benefit is not guaranteed. The detailed objective is not always clearly listed in the public registry; the study team can confirm.

Does this study involve a medication?

This appears to be a medication / drug study involving BI 1358894, Placebo, Quetiapine. Phase 2 studies usually explore whether the intervention may work, while continuing to monitor safety.

Who might this study be for?

This study may concern people with depression; age range: From 18 Years to 65 Years. The criteria appear fairly broad, but you should not assume you are eligible. The study team must confirm diagnosis, age, exclusions, available locations, and next steps.

What would I likely need to do?

You may need to take a study treatment and have regular medical follow-up. The listed study locations suggest that at least part of participation may involve a physical site. Ask whether some steps can be done remotely.

What side effects, interactions, or treatment changes should I check?

If the study involves a medication, ask whether it is already approved, experimental, or being tested for a new use. Check possible side effects, interactions with current treatment, dose changes, monitoring, and what happens if you feel worse. For any mental health study, also ask who to contact if you feel worse, whether participation may affect current treatment, whether you can stop, and who confirms eligibility.

Will I need to travel or attend in-person visits?

The listed study locations suggest that at least part of participation may involve a physical site. Ask which sites are open, how many visits are expected, whether any steps can be done remotely, and whether travel costs or compensation are listed.

Who is behind this study?

This study is sponsored by Boehringer Ingelheim, which appears to be unknown or unclear. If available, it can be useful to check the sponsor website, collaborators, investigator affiliation, and the official registry before deciding. HopeStage does not judge the quality of a sponsor or researcher, but helps you identify what to verify.

Can I still join this study?

The public registry lists this study as not currently recruiting. This page remains available for information. Check the official record for the latest status and explore other recruiting studies.

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