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BI 1358894 + Quetiapine for Depression

Phase 2
Waitlist Available
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have you been taking an SSRI or SNRI antidepressant for at least 4 weeks?
Are you age 18 to 65?
Timeline
Screening 28 weeks
Treatment 6 weeks
Follow Up 4 weeks
Awards & highlights

Study Summary

This trial is testing a new drug to see if it's effective in treating adults with depression who don't respond to standard antidepressants. The trial will last for 3 months and participants will be monitored for their symptoms and general health.

Who is the study for?
Adults aged 18-65 with major depressive disorder, who have been on SSRI or SNRI antidepressants for at least 4 weeks but haven't seen enough improvement. They must be experiencing a current depressive episode lasting between 8 weeks and 2 years. Exclusions include recent suicidal behavior, neurological illnesses like seizures or brain tumors, substance abuse within the last 3 months (except caffeine/tobacco), and ketamine treatment during the current episode.Check my eligibility
What is being tested?
The trial is testing four different doses of a new medicine called BI 1358894 plus placebo against quetiapine (an existing depression medication) plus placebo, and placebo alone in people taking their regular antidepressants. Participants are randomly assigned to one of six groups and will take tablets twice daily for about three months while their symptoms and health are monitored.See study design
What are the potential side effects?
Potential side effects aren't specified here but generally could include typical reactions to psychiatric medications such as dizziness, nausea, sleep disturbances, changes in appetite or weight, sexual dysfunction or increased risk of suicidal thoughts especially when starting any new antidepressant therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 28 weeks
Treatment ~ 6 weeks
Follow Up ~4 weeks
This trial's timeline: 28 weeks for screening, 6 weeks for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score
Secondary outcome measures
Change from baseline in Clinical Global Impression Severity Scale (CGI-S) score
Change from baseline in State-Trait Anxiety Inventory (STAI) State and Trait version scores
Change from baseline in Symptoms of Major Depressive Disorder Scale (SMDDS) total score
+1 more

Side effects data

From 2023 Phase 2 trial • 390 Patients • NCT04566601
35%
Headache
12%
Dizziness
12%
Anxiety
12%
Fatigue
10%
Insomnia
10%
Nausea
8%
Pyrexia
8%
Diarrhoea
6%
Nasopharyngitis
6%
Oropharyngeal pain
6%
Disturbance in attention
6%
Influenza
6%
COVID-19
6%
Suicidal ideation
6%
Pharyngitis
6%
Somnolence
4%
Dyspepsia
4%
Intentional self-injury
4%
Constipation
2%
Suicidal behaviour
2%
Increased appetite
2%
Weight increased
2%
Initial insomnia
2%
Dysmenorrhoea
100%
80%
60%
40%
20%
0%
Study treatment Arm
BI 1358894 5mg
BI 1358894 25mg
Placebo
BI 1358894 75mg
BI 1358894 125mg

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment group 2Experimental Treatment1 Intervention
Quetiapine
Group II: Treatment group 1Experimental Treatment1 Intervention
BI 1358894
Group III: Placebo groupPlacebo Group1 Intervention
Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Quetiapine
2003
Completed Phase 4
~3220
BI 1358894
2020
Completed Phase 2
~1160

Find a Location

Logistics

Travel, including flights, are covered

Your expenses for travel tickets for this trial will be reimbursed.

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,494 Previous Clinical Trials
10,916,457 Total Patients Enrolled

Media Library

BI 1358894 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04521478 — Phase 2
Major Depressive Disorder Research Study Groups: Treatment group 2, Treatment group 1, Placebo group
Major Depressive Disorder Clinical Trial 2023: BI 1358894 Highlights & Side Effects. Trial Name: NCT04521478 — Phase 2
BI 1358894 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04521478 — Phase 2
Major Depressive Disorder Patient Testimony for trial: Trial Name: NCT04521478 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medicinal applications does BI 1358894 have?

"BI 1358894 is a medication for the treatment of anxiety, bipolar disorder, mental depression and acute coryza."

Answered by AI

Are there a multitude of medical centers administering this clinical assessment in the state?

"The Hassman Research Institute, Optimus U Corporation and McLean Hospital all have active clinical trial sites enrolling patients. Moreover, there are 26 additional locations participating in this research effort."

Answered by AI

Could I potentially be eligible to join the research trial?

"Eligibility for this study requires that potential participants have a diagnosis of psychosis and are between the ages 18-65. Currently, 431 volunteers are being sought out to take part in the trial."

Answered by AI

Does this clinical experiment have any available spots for test subjects?

"Affirmative. Records hosted on clinicaltrials.gov demonstrate that this investigation, which was initially publicized on November 20th 2020, is currently enrolling participants. Approximately 431 patients are needed to be recruited from 26 different medical centres."

Answered by AI

Is there an age restriction on participants for this experiment?

"As outlined in the entry requirements, participants must be at least 18 and no older than 65 years old."

Answered by AI

Have there been any additional research studies conducted on BI 1358894?

"BI 1358894 was initially studied in 2014 at UT Southwestern Medical Center, with 18466 completed studies to date. Currently there are 13 running clinical trials based primarily out of Berlin, New jersey."

Answered by AI

What risks do patients face when taking BI 1358894?

"Considering the lack of efficacy data, while supported by some safety information, BI 1358894 was allocated a rating of 2."

Answered by AI

Is this a pioneering investigation?

"BI 1358894 is currently being tested in 138 cities and 27 countries through active trials. This medication, funded by Otsuka America Pharmaceutical, has a history of clinical testing: the initial Phase 4 drug approval trial was conducted back in 2014 with 200 participants; since then, 18,466 studies have been completed."

Answered by AI

How many participants can join this experiment?

"To successfully launch this medical trial, 431 patients fitting the criteria need to join. These individuals may come from two different sites: Hassman Research Institute in Berlin, New jersey and Optimus U Corporation located in Miami, Florida."

Answered by AI

Who else is applying?

What state do they live in?
Colorado
Pennsylvania
Other
Ohio
What site did they apply to?
Advanced Discovery Research LLC
Center For Emotional Fitness
The Ohio State University Wexner Medical Center
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
0
3+

Why did patients apply to this trial?

Other drugs did not work. I am tired 😫 of being depressed. i have insomina caused by depression.
PatientReceived no prior treatments
To try and do something for my depression. I’m tired of my meds not working to the full effect.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

Will i be stopping my clomipramine to test this new drug? Also, I am on seroquel for bipolar depression and sleep...is that ok?
PatientReceived no prior treatments

How responsive is this trial?

Average response time
  • < 1 Day
Typically responds via
Email
Most responsive sites:
  1. The Ohio State University Wexner Medical Center: < 24 hours
~99 spots leftby Mar 2025