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BI 1358894 + Quetiapine for Depression
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2023 Phase 2 trial • 390 Patients • NCT04566601Trial Design
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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?
Media Library
- You are between the ages of 18 and 65.You have shown suicidal behavior within the past year, including attempted suicide or preparing for suicide.You have a history of seizures, stroke, brain tumor, or any other serious neurological condition that could affect your ability to participate in the trial.You have been diagnosed with a drug or alcohol addiction within the last three months, except for caffeine and tobacco addiction.
- Group 1: Treatment group 2
- Group 2: Treatment group 1
- Group 3: Placebo group
- Screening: It may take up to 28 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 6 Weeks
- Follow Ups: You may be asked to continue sharing information regarding the trial for 4 Weeks after you stop receiving the treatment.
Frequently Asked Questions
What medicinal applications does BI 1358894 have?
"BI 1358894 is a medication for the treatment of anxiety, bipolar disorder, mental depression and acute coryza."
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."
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."
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."
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."
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."
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."
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."
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."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
What questions have other patients asked about this trial?
How responsive is this trial?
Average response time
- < 1 Day
Typically responds via
Most responsive sites:
- The Ohio State University Wexner Medical Center: < 24 hours
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