ERP-Based Mobile App for Obsessive-Compulsive Disorder

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile app called OC Free, designed to assist individuals with OCD (obsessive-compulsive disorder) who have contamination fears. The app complements regular therapy by providing additional support through exposure and response prevention (ERP), a common OCD treatment. The study aims to determine if the app is helpful and safe for individuals already in therapy and taking medications like SSRIs (a type of antidepressant). Suitable participants have mild to moderate OCD, confirmed contamination fears, and are already in therapy. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance OCD treatment options.

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.

What prior data suggests that this app is safe for treating OCD?

Research shows that the OC Free app, designed to help people with obsessive-compulsive disorder (OCD) practice therapy exercises at home, is currently being tested for safety and effectiveness. Although detailed safety information from past studies isn't available, reaching this stage indicates it is considered safe enough for broader testing.

This is a feasibility study, focusing on the app's functionality and user-friendliness. While complete safety data may not yet be available, the app is likely viewed as low-risk. It's important to note that this study doesn't involve testing a new drug, so the risks are generally lower than those in drug trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for OCD, which often rely on medications like SSRIs or traditional cognitive-behavioral therapy, BIXINK OC Free introduces an innovative approach by using a mobile-based ERP (Exposure and Response Prevention) intervention. This digital method allows for greater accessibility and flexibility, making it easier for patients to engage with therapy on their own schedule. Researchers are excited about BIXINK OC Free because it has the potential to enhance treatment adherence and effectiveness by integrating technology into mental health care, offering a more personalized and interactive experience for managing OCD symptoms.

What evidence suggests that this app is effective for treating OCD?

Research has shown that using Exposure and Response Prevention (ERP) through digital platforms can assist people with obsessive-compulsive disorder (OCD). A review of 17 studies found that 16 demonstrated improved understanding and behavior from online programs. This trial will evaluate the effectiveness of the mobile app BIXINK OC Free, which may help reduce anxiety related to obsessive thoughts and compulsive actions, especially when combined with traditional therapy. The app aims to make ERP more accessible by guiding users through safe exposure to their fears and helping them resist compulsive behaviors. Early results from similar programs support its potential to help manage OCD symptoms. ^{6 7 8 9 10}

Who Is on the Research Team?

Eric Hollander, MD

Principal Investigator

Spectrum Neuroscience and Treatment Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• BIXINK OC Free

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05166707

An ERP-based Mobile Intervention as an Adjunctive Treatment ... The objective of this feasibility study is to evaluate the feasibility, acceptability, and potential usefulness of the investigational device, ...

2. trialstoday.org trialstoday.org/list/print/NCT05166707

An ERP-based Mobile Intervention as an Adjunctive Treatment ... OC Free is a 6-week ERP-based intervention to deliver Exposure and Response Prevention (ERP) to reduce the anxiety from obsessive thoughts and compulsive ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1550624/

A Meta-Analysis of Behavioral Change Outcomes - PMC Sixteen of the 17 studied effect outcomes revealed improved knowledge and/or improved behavioral outcomes for participants using the Web-based interventions.

4. sigma.larvol.com sigma.larvol.com/facility.php?FacilityId=916469

Centre for Addiction and Mental Health (CAMH) Trials NCT05166707: An ERP-based Mobile Intervention as an Adjunctive Treatment for OCD. Recruiting. N/A. 30. US. BIXINK OC Free. BIXINK Therapeutics Co., Ltd.

5. uhra.herts.ac.uk uhra.herts.ac.uk/id/eprint/9910/1/WFSBP_3_PART_I.pdf

Guidelines for the treatment of anxiety and obsessiv ... A systematic review of the clinical effectiveness and cost-effectiveness of pharmacological and psychological interventions. Page 73. 73 for ...

6. koreabiomed.com koreabiomed.com/news/articleView.html?idxno=13748

Bixink Therapeutics signs deals to expand DTx pipelines - KBR Based on the safety and efficacy data, the ... Bixink is conducting a U.S. trial of OC Free, a DTx to treat obsessive-compulsive disorder.

7. withpower.com withpower.com/trial/phase-obsessive-compulsive-disorder-9-2021-c212a

An ERP-based Mobile Intervention ... This trial tests an app called OC Free that helps adults with severe contamination OCD practice their therapy exercises at home.

8. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05166707/an-erp-based-mobile-intervention-as-an-adjunctive-treatment-for-ocd

An ERP-based Mobile Intervention as an Adjunctive ... OC Free is an iOS/Android app that provides treatment via computerized exposure and response prevention (ERP). The study will evaluate ...

9. fdaaa.trialstracker.net fdaaa.trialstracker.net/trial/NCT05166707/

An overdue trial by BIXINK Therapeutics Co., Ltd. A Prospective, Single Arm, Open, Single-center, Feasibility Study to Assess the Effectiveness and Safety of Mobile App (OC Free) for Patients With Obsessive- ...

10. en.bixink.com en.bixink.com/

BIXINK BIXINK, Breast cancer adjuvant treatment 'Nerlynx' has entered into Big 5 General Hospital. 21 Sep 2022