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Depressive Disorder, MajorPhase 2NCT04521478

A Study to Test the Effect of Different Doses of BI 1358894 and Quetiapine in People With Depression

A Phase 2 study testing BI 1358894 and Quetiapine in people with Depressive Disorder, Major, run by Boehringer Ingelheim at 120 sites in 14 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

This study is open to adults with depression (major depressive disorder) for whom standard treatment with antidepressants alone does not work sufficiently. The purpose of the trial is to find out whether a medicine called BI 1358894 helps to improve symptoms of depression. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Depressive Disorder, Major
What is being tested?
BI 1358894 and Quetiapine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
389 participants
Where
120 sitesin 14 countries
Study dates
20 Nov 2020to 2 Feb 2024
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

  • --Established diagnosis of Major Depressive Disorder (MDD), single episode or recurrent, as confirmed at the time of screening by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, 5th version (DSM-5) (SCID-5), with a duration of current depressive episode ≥ 8 weeks and ≤ 24 months at the time of screening visit
  • Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥ 24 at screening, as confirmed by a trained site based rater AND interactive, computer administered MADRS. The difference in the rater and computer administered MADRS must not exceed more than 7 points (for details refer to section 6.2). In addition, trial participants must have a score of ≥ 3 on the Reported Sadness Item on both MADRS scales (computer administered and rater-administered MADRS)
  • A documented ongoing monotherapy treatment of ≥ 4 weeks at the screening visit, with bupropion or a protocol specified Selective Serotonin Reuptake Inhibitor (SSRI) or Serotonin Norepinephrine Reuptake Inhibitor (SNRI) (refer to the ISF) at adequate dose (at least minimum effective dose as per prescribing information and as confirmed per detectable drug levels in the screening blood or urine sampling)
  • Male and female participants, 18 to 65 years of age, both inclusively at the time of consent
  • Women who are of child-bearing potential (WOCBP)1 must be able and willing, as confirmed by the investigator, to use two methods of contraception which include one highly effective method of birth control per ICH M3 (R2) that result in a low failure rate of less than 1%, plus one additional barrier
  • Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
  • Able to communicate well, and to understand and comply with trial requirements

Who cannot join

  • Per DSM-5, had ever met diagnostic criteria for schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar disorder, delusional disorder or MDD with psychotic features as assessed by the Structured Clinical Interview for DSM-5 Clinical Trials (SCID-5) at the time of screening
  • Diagnosis of any other mental disorder (in addition to those as described in Exclusion Criterion #1) that was the primary focus of treatment within 6 months prior to screening or at baseline (as per clinical discretion of the investigator)
  • Diagnosis with antisocial, paranoid, schizoid or schizotypal personality disorder as per DSM-5 criteria, at the time of screening visit. Any other personality disorder at screening visit that significantly affects current psychiatric status and likely to impact trial participation, as per the judgement of investigator
  • Diagnosis of a substance related disorder within 3 months prior to screening visit (with exception of caffeine and tobacco)
  • History of seizure disorders, stroke, brain tumor or any other major neurological illness that can impact participation in the trial
  • History of more than 2 unsuccessful monotherapy treatments (at adequate dosage and duration, per local prescribing information of the product) with an approved antidepressant medication for the current ongoing major depressive episode. These include ongoing monotherapy treatment with bupropion or a protocol specified SSRI or SNRI as described in Inclusion Criterion #3
  • Any suicidal behavior in the past 12 months prior to screening (per investigator judgement including an actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behaviour)
  • Any suicidal ideation of type 4 or 5 in the Columbia Suicide Severity Rating Scale (CSSRS) in the past 3 months prior to screening or at screening or baseline visit (i.e. active suicidal thought with method and intent but without specific plan, or active suicidal thought with method, intent and plan)

Trial locations and contacts

120 sites in 14 countries.

120 sites in 14 countries

United States29 sites

  • Lehigh Center for Clinical Research

    Allentown, Pennsylvania, 18104

  • Advanced Discovery Research LLC

    Atlanta, Georgia, 30318

  • Atlanta Center

    Atlanta, Georgia, 30331

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Center For Emotional Fitness

    Cherry Hill, New Jersey, 08002

  • Chicago Research Center, Incorporated

    Chicago, Illinois, 60634

  • University of Cincinnati

    Cincinnati, Ohio, 45219

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

  • CT Clinical Research

    Cromwell, Connecticut, 06416

  • Mountain Mind. LLC

    Denver, Colorado, 80202

  • Core Clinical Research

    Everett, Washington, 98201

  • Precise Research Centers

    Flowood, Mississippi, 39232

  • Gulf Coast Clinical Research Center

    Fort Myers, Florida, 33912

  • Sarkis Clinical Trials

    Gainesville, Florida, 32607

  • Collaborative Neuroscience Network, LLC (CNS)

    Garden Grove, California, 92845

  • Institute of Living

    Hartford, Connecticut, 06106

  • Clinical Neuroscience Solutions, Inc

    Jacksonville, Florida, 32256

  • Alliance Research

    Long Beach, California, 90807

  • Hassman Research Institute

    Marlton, New Jersey, 08053

  • Optimus U Corporation

    Miami, Florida, 33135

  • Global Medical Institutes, LLC, Scranton Medical Institute

    Moosic, Pennsylvania, 18507

  • Synexus Clinical Research US, Inc.

    New York, New York, 10017

  • Psychiatric Care and Research Center

    O'Fallon, Missouri, 63368

  • Asclepes Research Centers

    Sherman Oaks, California, 91403

  • California Neuroscience Research

    Sherman Oaks, California, 91403

  • Schuster Medical Research Institute

    Sherman Oaks, California, 91403

  • Viking Clinical Research, Ltd.

    Temecula, California, 92591

  • Collaborative Neuroscience Research, LLC

    Torrance, California, 90504

  • University of Kansas School of Medicine-Wichita

    Wichita, Kansas, 67214

Other trials in United States

Japan20 sites

  • National Center for Global Health and Medicine Kohnodai Hospital

    Chiba, Ichikawa, 272-8516

  • Kaku Mental Clinic

    Fukuoka, Fukuoka, 810-0022

  • Fukuoka University Hospital

    Fukuoka, Fukuoka, 814-0180

  • Kuramitsu Hospital

    Fukuoka, Fukuoka, 819-0037

  • Hokudai-dori Mental Health Clinic

    Hokkaido, Sapporo, 001-0010

  • Arai Clinic

    Hyogo, Amagasaki, 660-0882

  • Tatsuta Clinic

    Hyogo, Kobe, 651-0097

  • Kishiro Mental Clinic

    Kanagawa, Kawasaki, 214-0014

  • Yutaka Clinic

    Kanagawa,Sagamihara, 252-0303

  • Yuge Neuropsychiatric Hospital

    Kumamoto, Kumamoto, 861-8002

  • Arata Clinic

    Nagasaki, Nagasaki, 852-8154

  • Nara Medical University Hospital

    Nara, Kashihara, 634-8522

  • Rainbow and Sea Hospital

    Saga, Karatsu, 847-0031

  • Inuo Hospital

    Saga, Tosu, 841-0081

  • National Center of Neurology and Psychiatry

    Tokyo, Kodaira, 187-8851

  • Tamachi mita cocoromi Clinic

    Tokyo, Minato-ku, 108-0023

  • Sancha Mental Clinic

    Tokyo, Setagaya-ku, 154-0004

  • Maynds Tower Mental Clinic

    Tokyo, Shibuya-ku, 151-0053

  • Ichigaya Himorogi Clinic

    Tokyo, Shinjuku-ku, 162-0843

  • Ohwa Mental Clinic

    Tokyo, Toshima-ku, 170-0002

Other trials in Japan

France9 sites

  • HOP Dijon-Bourgogne

    Dijon, 21079

  • CAB Médical Psyché

    Douai, 59500

  • CAB Ambroise Paré

    Élancourt, 78990

  • HOP la Colombière

    Montpellier, 34295

  • HOP Saint-Jacques

    Nantes, 44093

  • HOP Pasteur

    Nice, 06000

  • HOP Carémeau

    Nîmes, 30029

  • CTR Psychiatrique Universitaire

    Saint-Cyr-sur-Loire, 37540

  • HOP Purpan

    Toulouse, 31059

Other trials in France

Argentina8 sites

  • Fundación para el Estudio y Tratamiento de las Enfermedades Mentales (FETEM)

    CABA, C1133AAH

  • CEN (Centro Especializado Neurociencias)

    Córdoba, 5004

  • Instituto DAMIC - Fundacion Rusculleda

    Córdoba, X5003DCE

  • CENPIA-Centro de Estudios Neuropsiquiátricos y Psicológicos Integral Ambulatorio

    La Plata, 1900

  • Clinica Privada de Salud Mental Santa Teresa de Avila

    La Plata, 1900

  • Instituto de Neurociencias San Agustín

    La Plata, 1900

  • Instituto Médico de la Fundación Estudios Clínicos

    Rosario, S2000DEJ

  • Centro de Investigacion y Asistencia en Psiquiatria (CIAP)

    Rosario, S2000QJI

Other trials in Argentina

Slovakia8 sites

  • MUDr. Beata Dupejová

    Banská Bystrica, 974 04

  • J & J SMART, s.r.o., psychiatric clinic

    Bratislava, 81107

  • MENTUM s.r.o.

    Bratislava, 82007

  • EPAMED s.r.o.

    Košice, 040 01

  • Psychiatricka klinika I.UN L. Pasteura

    Košice, 4001

  • CENTRUM ZDRAVIA R.B.K, s.r.o., psychiatric clinic

    Svidník, 089 01

  • Pro mente sana s.r.o., Psychiatric clinic

    Trenčín, 911 01

  • Crystal Comfort s.r.o

    Vranov nad Topľou, 093 01

Other trials in Slovakia

Czechia7 sites

  • Neuropsychiatry, s.r.o.

    Hradec Králové, 500 09

  • Clinical Research Foundation s.r.o

    Kladno, 27201

  • MP Meditrine s.r.o.

    Ostrava, 708 00

  • A-SHINE s.r.o

    Pilsen, 31200

  • Clintrial s.r.o.

    Prague, 10000

  • AD71 s.r.o.

    Prague, 10900

  • INEP medical s.r.o.

    Prague, 18600

Other trials in Czechia

Russia7 sites

  • Federal State Budget Institution "Mental Health Research Center"

    Moscow, 115522

  • SBI of HC "Z. P. Solovyov Scientific&pract psychoneurolog.Cent"

    Moscow, 129110

  • SBHI "Psychiatric Hospital #1 P.P.Kashchenko"

    Saint Petersburg, 190121

  • FSBI Bekhterev Net.Med.Res.Cen.of Psych&Neuro

    Saint Petersburg, 192019

  • LLC "MK-Med"

    Saint Petersburg, 197373

  • SHI "Reg.Clin.Psychiatric Hosp.of Saint Sophia"

    Saratov, 410060

  • FSBEI of HE Smolensk State Medical University

    Smolensk, 214019

Other trials in Russia

Germany6 sites

  • Zentrum für klinische Forschung Dr. med. I. Schöll GmbH

    Bad Homburg, 61350

  • Universitätsklinikum Frankfurt

    Frankfurt am Main, 60590

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, 55131

  • Zentralinstitut für seelische Gesundheit

    Mannheim, 68159

  • Praxis für Psychiatrie und Psychotherapie

    Stralsund, 18439

  • Studienzentrum Nord-West

    Westerstede, 26655

Other trials in Germany

Poland6 sites

  • Synexus Polska SCM Sp. z o.o. Gdansku, Gdansk

    Gdansk, 80-382

  • Synexus Lodz Medical Center

    Lodz, 90127

  • Specialist Psychiatric Healthcare Centre in Lodz

    Lodz, 91-229

  • Clinical Best Solutions

    Lublin, 20-078

  • Centrum Medyczne "Luxmed" Sp. z o.o.

    Lublin, 20-109

  • Synexus Poland, Branch in Poznan

    Poznan, 60-702

Other trials in Poland

Spain6 sites

  • Hospital Universitario Fundación Alcorcón

    Alcorcón, 28922

  • Hestia Palau

    Barcelona, 08025

  • Hospital Clínic de Barcelona

    Barcelona, 08036

  • Hospital Jerez de la Frontera

    Jerez de la Frontera, 11407

  • Hospital Ramón y Cajal

    Madrid, 28034

  • Centro de Salud de San Juan

    Salamanca, 37005

Other trials in Spain

Australia4 sites

  • Peninsula Therapeutic and Research Group

    Frankston, Victoria, 3199

  • Albert Road Clinic

    Melbourne, Victoria, 3004

  • Monash Alfred Psychiatry Research Centre

    Melbourne, Victoria, 3004

  • Griffith Health

    Southport, Queensland, 4125

Other trials in Australia

Canada4 sites

  • University of Calgary

    Calgary, Alberta, T2N 4Z6

  • OCT Research ULC

    Kelowna, British Columbia, V1Y 1Z9

  • Braxia Scientific Corp. (CRTCE Mississauga)

    Mississauga, Ontario, L5C 4E7

  • Centre for Addiction and Mental Health (CAMH)

    Toronto, Ontario, M6J 1H4

Other trials in Canada

Bulgaria3 sites

  • Mental Health Center "Prof. Dr. Ivan Temkov - Burgas" EOOD

    Burgas, 9001

  • Filipopolis Ambulatory for Group Practice for Specialized Care in Psychiatry

    Plovdiv, 4000

  • Medical Center Intermedica Ltd.

    Sofia, 1680

Other trials in Bulgaria

Hungary3 sites

  • Obuda Health Center

    Budapest, 1036

  • Semmelweis University

    Budapest, 1083

  • Bugat Pal Hospital, Gyongyos

    Gyöngyös, 3200

Other trials in Hungary

About this study

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.

This study is open to adults with depression (major depressive disorder) for whom standard treatment with antidepressants alone does not work sufficiently. The purpose of the trial is to find out whether a medicine called BI 1358894 helps to improve symptoms of depression. Four different doses of BI 1358894 are tested in the study. Participants continue their standard antidepressant therapy throughout the study. Participants are put into 6 groups by chance. Participants in 4 of the 6 groups take different doses of BI 1358894, and placebo. Participants in the fifth group take quetiapine, a medicine already used to treat depression, and placebo. Participants in the sixth group take placebo only.

Participants take BI 1358894, quetiapine, or placebo as tablets. Placebo tablets look like BI 1358894 or quetiapine tablets but do not contain any medicine. Each participant takes tablets twice a day. Participants are in the study for about 3 months. During this time, they visit the study site about 8 times and get about 2 phone calls. At the visits, doctors ask participants about their symptoms.

The results between the BI 1358894 groups, the quetiapine group, and the placebo group are then compared. The doctors also regularly check the general health of the participants.

Being tested
BI 1358894, Placebo, Quetiapine
Medical subject headings
Depressive Disorder, Major

What participants receive

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

  • BI 1358894Drug

    BI 1358894

  • PlaceboDrug

    Placebo

  • QuetiapineDrug

    quetiapine

Study groups in NCT04521478
Study groupRoleWhat they receive
5 mg BI 1358894ExperimentalParticipants with an established diagnosis of MDD administered one 5 milligram (mg) dose of BI 1358894 in the morning as film-coated tablet, and one dose of placebo matching quetiapine in the evening as tablets. Each administration was performed orally once daily, for 6 weeks. During the trial, participants also continued treatment with their OAD.
Receives: Drug: BI 1358894
PlaceboPlacebo comparatorParticipants with an established diagnosis of Major Depressive Disorder (MDD) administered one dose of placebo matching BI 1358894 in the morning as film-coated tablets, and one dose of placebo matching quetiapine in the evening as tablets. Each administration was performed orally once daily, for 6 weeks. During the trial, participants also continued treatment with their Ongoing Antidepressants (OAD).
Receives: Drug: Placebo
QuetiapineActive comparatorParticipants with an established diagnosis of MDD administered one dose of placebo matching BI 1358894 in the morning as film-coated tablets, and one 150 or 300 mg dose of quetiapine in the evening as tablets. Each administration was performed orally once daily, for 6 weeks. The daily active dose at the start of therapy was 50 mg on Day 1, 100 mg at Day 2 and 150 mg on Day 3 and 4. Beginning with Day 5, the recommended daily dose of 300 mg was taken. If not tolerated by a participant, the dose was reduced to 150 mg in Week 1. Thereafter, this finally chosen dose had to be stable until end of treatment at Week 6. During the trial, participants also continued treatment with their OAD.
Receives: Drug: Quetiapine
25 mg BI 1358894ExperimentalParticipants with an established diagnosis of MDD administered one 25 mg dose of BI 1358894 in the morning as film-coated tablet, and one dose of placebo matching quetiapine in the evening as tablets. Each administration was performed orally once daily, for 6 weeks. During the trial, participants also continued treatment with their OAD.
Receives: Drug: BI 1358894
75 mg BI 1358894ExperimentalParticipants with an established diagnosis of MDD administered one 75 mg dose of BI 1358894 in the morning as film-coated tablets, and one dose of placebo matching quetiapine in the evening as tablets. Each administration was performed orally once daily, for 6 weeks. During the trial, participants also continued treatment with their OAD.
Receives: Drug: BI 1358894
125 mg BI 1358894ExperimentalParticipants with an established diagnosis of MDD administered one 125 mg dose of BI 1358894 in the morning as film-coated tablets, and one dose of placebo matching quetiapine in the evening as tablets. Each administration was performed orally once daily, for 6 weeks. During the trial, participants also continued treatment with their OAD.
Receives: Drug: BI 1358894

What is being measured

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

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

    Change from baseline in MADRS total score at Week 6 is reported. The MADRS evaluates core symptoms of depression and consists of 10 items. Nine of them are based upon participant reports, and one is on the rater's observation (apparent sadness) during the rating interview. MADRS items are rated on a 0-6 continuum (0=no abnormality, 6=severe). The possible total score could range from 0 (normal with absence of symptoms) to 60 (severe depression).

    Least squares mean and adjusted standard error were estimated by Restricted Maximum Likelihood (REML)-based Mixed effects model for repeated measures (MMRM) including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline MADRS total score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.

    Measured: MMRM included measurements from baseline (Week 0) and at Weeks 1, 2, 4 and 6 after first drug administration. MMRM estimates of change from baseline to Week 6 is reported.

Secondary outcomes (4)

  1. Number of Participants With Response Defined as ≥ 50% Montgomery-Åsberg Depression Rating Scale (MADRS) Reduction From Baseline at Week 6

    Number of participants with response defined as ≥ 50% MADRS reduction from baseline at Week 6 is reported. Percent reduction from baseline was calculated as follows: [(MADRS total score at baseline - MADRS total score at week 6)/ MADRS total score at baseline] *100.

    Measured: Prior to the first intake of the trial medication (week 0, baseline) and after 6 weeks of treatment.

  2. Change From Baseline in State-Trait Anxiety Inventory (STAI) State and Trait Version Scores at Week 6

    Change from baseline in STAI State and Trait version scores at Week 6 is reported. The STAI comprises separate self-report scales for measuring state and trait anxiety. Both consist of 20 statements. The S-Anxiety scale evaluates how respondents feel "right now, at this moment." The T-Anxiety scale assesses how people generally feel. Each STAI item is given a weighted score of 1 to 4. Scores for both scales can vary from 20 (minimum) to 80 (maximum). Higher scores indicate greater anxiety.

    Least squares mean and adjusted standard error were estimated by REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.

    Measured: MMRM included measurements from baseline (Week 0) and at Weeks 1, 2, 4 and 6 after first drug administration. MMRM estimates of change from baseline to Week 6 is reported.

  3. Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) Score at Week 6

    Change from baseline in CGI-S score at Week 6 is reported. The CGI-S rating scale evaluates the severity of psychopathology on a scale of 1 to 7. Considering total clinical experience with the depression population, a participant is assessed on severity of illness at the time of rating according to: 1=normal (not at all ill); 2=borderline ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill participants.

    Least squares mean and adjusted standard error were estimated by REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of the baseline score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.

    Measured: MMRM included measurements from baseline (Week 0) and at Weeks 1, 2, 4 and 6 after first drug administration. MMRM estimates of change from baseline to Week 6 is reported.

  4. Change From Baseline in Symptoms of Major Depressive Disorder Scale (SMDDS) Total Score at Week 6

    Change from baseline in SMDDS total score at Week 6 is reported. The SMDDS is a 16-item, patient-reported outcome measure developed to capture the core symptoms of MDD. The SMDDS uses a recall of "over the past 7 days" and participants respond to each question using a rating scale between 0 ("Not at all" or "Never") to 4 ("Extremely" or "Always"). The total score ranges from 0 to 60 with a higher score indicating more severe depressive symptomatology.

    Least squares mean and adjusted standard error were estimated by REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of the baseline score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.

    Measured: MMRM included measurements from baseline (Week 0) and at Weeks 1, 2, 4 and 6 after first drug administration. MMRM estimates of change from baseline to Week 6 is reported.

Timeline

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

  1. First posted20 Aug 2020
  2. Study start20 Nov 2020
  3. Primary completion10 Jan 2024
  4. Study completion2 Feb 2024

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
Double blind
Who is masked
Participant, Investigator
Enrolment
389 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04521478
Sponsor's protocol ID
1402-0011
Other IDs
2019-004264-21, 2019
Status last verified
Feb 2025
First submitted
18 Aug 2020
Last updated
6 Mar 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.

Publications

  • Shelton RC, Pizzagalli DA, Cohen EA, Hori H, Dickschat U, Asafu-Adjei J, Feldbarg A, Just S, Roehrle M, Sommer S, Sussmuth SD. Efficacy, Tolerability, and Safety of TRPC4/5 Inhibitor BI 1358894 in Patients With Major Depressive Disorder and Inadequate Response to Antidepressants: A Phase 2 Randomized, Placebo-Controlled, Parallel Group, Dose-Ranging Trial. J Clin Psychiatry. 2025 Sep 3;86(3):25m15868. doi: 10.4088/JCP.25m15868.

    PubMed 40900110

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BI 1358894 and Quetiapine in people with Depressive Disorder, Major, run by Boehringer Ingelheim at 120 sites in 14 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 7 inclusion and 8 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 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 120 sites in United States, Japan, France, Argentina, Slovakia and 9 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 6 Mar 2025). 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-Åsberg Depression Rating Scale (MADRS) Total Score at Week 6 (time frame: MMRM included measurements from baseline (Week 0) and at Weeks 1, 2, 4 and 6 after first drug administration. MMRM estimates of change from baseline to Week 6 is reported.). 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 NCT04521478, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.

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