An ERP-based Mobile Intervention as an Adjunctive Treatment for OCD

Overseen By Nick Lee, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: BIXINK Therapeutics Co., Ltd.

Must be taking: Serotonin Reuptake Inhibitors

Disqualifiers: Psychotic disorders, Bipolar, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 6 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests an app called OC Free that helps adults with severe contamination OCD practice their therapy exercises at home. The app uses a method to help them face their fears and reduce compulsive behaviors. The study will check if the app is safe and effective over several weeks. This method is a well-established treatment for OCD, known for its effectiveness in reducing symptoms.

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current medications. In fact, you must be on a stable dose of a Serotonin Reuptake Inhibitor (SRI) or Selective Serotonin Reuptake Inhibitor (SSRI) for at least 6 weeks before joining the study.

Is the treatment BIXINK OC Free generally safe for humans?

The treatment, also known as BIA 10-2474, was involved in a first-in-human clinical trial that resulted in serious adverse events, including one death, among healthy volunteers. This suggests potential safety concerns that should be carefully considered. ^{1 2 3 4 5}

Research Team

Eric Hollander, MD

Principal Investigator

Spectrum Neuroscience and Treatment Institute

Eligibility Criteria

Inclusion Criteria

You have a certain level of severity in your symptoms, as determined by a rating scale called the CGI-Severity score.

Primary DSM-5 diagnosis of obsessive-compulsive disorder

Mild to Moderate OCD severity (8 ≤ Y-BOCS ≤ 23)

Exclusion Criteria

You have a history of or current symptoms of a mental illness that causes delusions, in the opinion of the person in charge of the study.

You have attempted suicide in the past year or are at risk of doing so, according to the investigator and C-SSRS assessment.

You have a history of behaviors that could be harmful to yourself or others, as determined by the person conducting the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive ERP-based intervention via OC Free app for OCD treatment

6 weeks

Weekly virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person), 1 virtual check-in

Treatment Details

Interventions

• BIXINK OC Free

Participant Groups

Group I: BIXINK OC Free Experimental Treatment 1 Intervention

A 6 week ERP-based intervention

Who Is Running the Clinical Trial?

BIXINK Therapeutics Co., Ltd.

Lead Sponsor

Trials

1

Recruited

30+

Findings from Research

The recent fatal adverse event in the BIA-102474-101 clinical trial highlights significant limitations in the current safety review process for first-into-human trials, despite previous trials with similar compounds being conducted without incident.

To improve safety in future trials, it is crucial to implement sequential dosing strategies, thorough reviews of preclinical toxicity studies, and systematic risk assessments, especially for novel compounds that may pose higher risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implications of the BIA-102474-101 study for review of first-into-human clinical trials. Eddleston, M., Cohen, AF., Webb, DJ.[2021]

The first-in-human clinical trial of BIA 10-2474 resulted in serious adverse events for 6 healthy volunteers, including 1 death, highlighting the heightened risks associated with novel investigational drugs transitioning from animal studies to human trials.

The symposium emphasized the need for careful planning and communication in clinical trials to minimize risks to participants, suggesting that a complex matrix of factors must be considered to ensure safety and integrity in first-in-human studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety in FIH Trials: A Summary of the Symposium "Fatal Drug Trial in Phase 1: Understanding Risk, Subject Safety, Timelines, and Cost". Greenberg, HE., van Iersel, MT., Westrick, ML., et al.[2020]

Rivaroxaban was associated with a statistically significant increased risk of drug-induced liver injury (DILI), particularly acute liver failure (ALF), with a reporting odds ratio of 2.08, indicating a need for further studies to assess its safety.

In contrast, dabigatran did not show a significant association with DILI, and a large percentage of DILI cases for both drugs involved concomitant use of other hepatotoxic medications, highlighting the importance of monitoring for liver injury in patients taking NOACs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liver injury with novel oral anticoagulants: assessing post-marketing reports in the US Food and Drug Administration adverse event reporting system. Raschi, E., Poluzzi, E., Koci, A., et al.[2018]

The Drug Adverse Reaction Database (DART) provides detailed information on 147 confirmed and 89 potential protein targets associated with adverse drug reactions (ADRs), which is crucial for understanding the mechanisms behind these reactions and aiding in drug discovery.

DART includes extensive data on 257 drugs and 1080 ligands, offering insights into their binding properties, physiological functions, and the specific adverse effects they may cause, making it a valuable resource for researchers and developers in pharmacology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug Adverse Reaction Target Database (DART) : proteins related to adverse drug reactions. Ji, ZL., Han, LY., Yap, CW., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Implications of the BIA-102474-101 study for review of first-into-human clinical trials. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Safety in FIH Trials: A Summary of the Symposium "Fatal Drug Trial in Phase 1: Understanding Risk, Subject Safety, Timelines, and Cost". [2020]

3. England pubmed.ncbi.nlm.nih.gov

Liver injury with novel oral anticoagulants: assessing post-marketing reports in the US Food and Drug Administration adverse event reporting system. [2018]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Drug Adverse Reaction Target Database (DART) : proteins related to adverse drug reactions. [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Novel Computational Approach to Predict Off-Target Interactions for Small Molecules. [2021]