BI 1358894 for PTSD

No longer recruiting at 37 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Travel: May Be Covered

Trial Phase: Phase 2

Sponsor: Boehringer Ingelheim

Must not be taking: Stimulants

Disqualifiers: Schizophrenia, Bipolar, Psychotic disorders, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medicine, BI 1358894, to determine if it can reduce symptoms of post-traumatic stress disorder (PTSD) in adults. Participants will take either BI 1358894 or a placebo (a pill resembling the medicine but without active ingredients) daily for two months. The study seeks individuals with PTSD who have had the condition for at least three months and consider it their primary mental health challenge. During the trial, doctors will monitor participants' health and any changes in PTSD symptoms. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you cannot use stimulant medications within 3 months before the screening visit, and your current psychotherapy must be stable and not trauma-focused.

Is there any evidence suggesting that BI 1358894 is likely to be safe for humans?

Research has shown that BI 1358894 has been tested in people with major depressive disorder, yielding promising safety results. Studies found that daily use of BI 1358894 for six weeks was generally well-tolerated, with most participants not experiencing serious side effects. Another study found the treatment was safe for both Japanese and Caucasian men.

These findings suggest that BI 1358894 might also be safe for people with post-traumatic stress disorder. However, as this trial remains in an early stage, more information is needed to confirm its safety. Participants will be closely monitored to ensure no unexpected problems arise. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for PTSD?

BI 1358894 is unique because it offers a new hope for treating Post-traumatic Stress Disorder (PTSD) by potentially working differently than traditional options like SSRIs or SNRIs, which primarily focus on altering neurotransmitter levels. Researchers are excited about BI 1358894 because it targets specific neural pathways involved in stress response, which could lead to more effective relief of PTSD symptoms. Additionally, BI 1358894 might provide faster results compared to existing treatments, offering quicker symptom reduction and improving patients' quality of life more swiftly.

What evidence suggests that BI 1358894 might be an effective treatment for post-traumatic stress disorder?

Research on the drug BI 1358894, which participants in this trial may receive, has shown mixed results. Some studies found that people tolerated this medication well, as it didn't cause serious side effects. However, it didn't clearly improve symptoms for conditions like major depressive disorder. Despite these findings, researchers continue to study BI 1358894 for its potential effects on post-traumatic stress disorder (PTSD). The drug targets specific proteins in the brain that may influence mood and stress. While previous studies haven't proven it effective for depression, researchers hope it might help with PTSD symptoms. Participants in this trial may also receive a placebo, serving as a control to better understand the effects of BI 1358894. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

Inclusion Criteria

You have been diagnosed with Post-Traumatic Stress Disorder (PTSD) based on standard guidelines.

Did your traumatic event occur more than 3 months ago?

A total severity score of ≥ 33 on the PTSD Checklist for DSM-5 (PCL-5) at the screening visit

Exclusion Criteria

Have you taken any stimulants in the past 3 months?

Are you currently taking any stimulants?

You are not involved in any legal process related to the traumatic event

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take BI 1358894 or placebo as tablets every day for 8 weeks

8 weeks

8 visits (in-person), 4 phone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BI 1358894
• Placebo

How Is the Trial Designed?

Group I: BI 1358894 125 mg Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+

Citations

1. psychiatrist.com psychiatrist.com/jcp/efficacy-tolerability-safety-trpc4-5-inhibitor-bi-1358894-major-depressive-disorder-inadequate-response-antidepressants-phase-2-randomized-placebo-controlled-parallel-group-dose-ranging-trial/

Efficacy, Tolerability, and Safety of TRPC4/5 Inhibitor BI ... Results: Of 940 enrolled patients, 389 were randomized, and 361 (93.0%) completed the trial. No differences were observed between BI 1358894 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04521478

A Study to Test the Effect of Different Doses of BI 1358894 ... 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11665782/

Safety of BI 1358894 in patients with major depressive disorder Data indicate that daily BI 1358894 125 mg treatment over 6 weeks was generally well‐tolerated and safe. Efficacy evaluation was not performed ...

4. ascpt.onlinelibrary.wiley.com ascpt.onlinelibrary.wiley.com/doi/abs/10.1111/cts.70102

Safety of BI 1358894 in patients with major depressive ... Safety of BI 1358894 in patients with major depressive disorder: Results and learnings from a phase II randomized decentralized clinical trial.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39832346/

Efficacy and Safety of BI 1358894 in Patients ... Conclusions: Although the primary end point was not met, BI 1358894 was well tolerated with no increase in self harm or suicidality. More ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11088545/

Safety, Tolerability, and Pharmacokinetics of Oral BI ... BI 1358894 was well tolerated with a favorable pharmacokinetic profile in Japanese male HVs, similar to findings from a previous study in Caucasian male HVs.