Trials Sponsors Conditions Drugs Pricing

Conditions

Obsessive-Compulsive Disorder Obsessive-compulsive Disorders and Symptoms

Outcome Measures

Primary Outcomes (1)

Yale-Brown Obsessive-Compulsive Scale (Y-BOCs)
The Y-BOCS is the gold-standard, semi-structured clinician-administered assessment of OCD severity. It contains 10 items ranging from 0 to 4, which are summed to generate a total score (range = 0-40). Higher scores indicate more severe OCD symptoms. The Y-BOCS will be used to assess change in OCD symptoms from baseline to endpoint.
Screening/Baseline (week 0), Endpoint (week 6), Follow-up (week 10)

Secondary Outcomes (4)

Clinical Global Impression - Improvement scale (CGI-I)
Endpoint (week 6), Follow-up (week 10)
Clinical Global Impression-Severity Scale (CGI-S)
Screening/Baseline (week 0), Endpoint (week 6), Follow-up (week 10)
Beck Depression Inventory II
Screening/Baseline (week 0), Endpoint (week 6), Follow-up (week 10)
Beck Anxiety Inventory
Screening/Baseline (week 0), Endpoint (week 6), Follow-up (week 10)

Study Arms (1)

BIXINK OC Free

EXPERIMENTAL

A 6 week ERP-based intervention

Device: BIXINK OC Free

Interventions

BIXINK OC FreeDevice

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 rituals.

BIXINK OC Free

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Ages 18 years and older
Primary DSM-5 diagnosis of obsessive-compulsive disorder

Sponsors & Collaborators

BIXINK Therapeutics Co., Ltd.
Industrylead

Study Sites (1)

Spectrum Neuroscience and Treatment Institute

New York, New York, 10021, United States

RECRUITING

Emily Sachs, BACONTACT646-351-0220 emilysachs@spectrumneuroscience.org

Eric Hollander, MDPRINCIPAL INVESTIGATOR

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Study Officials

Eric Hollander, MD
Spectrum Neuroscience and Treatment Institute
PRINCIPAL INVESTIGATOR

Central Study Contacts

Nick Lee, MS

CONTACT

+82-70-5223-2869 cl.lee@bixink.com

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 12, 2021

First Posted

December 22, 2021

Study Start

October 18, 2021

Actual (reported)

Primary Completion

November 18, 2022

Actual (reported)

You may not qualify if:

Subjects who are study site staff members or subjects who are employees directly involved in the conduct of the study
Subjects with a history of at least two (2) treatment failures with a Serotonin Reuptake Inhibitor (SRI) and/or Selective Serotonin Reuptake Inhibitor (SSRI) at a confirmed adequate dose and for an adequate duration, as determined by the investigator
Severe and extreme OCD severity (Y-BOCS ≥ 24)
Current or previous symptoms of psychosis, including delusions, or history consistent with a psychotic disorder, in the opinion of the investigator
Current or previous compulsions that may place the subject or others at risk, in the opinion of the Investigator
History of a violent tendencies, action(s) or thoughts or predilection towards violence in the opinion of the Investigator
Any comorbid diseases or disorders (as determined by clinical judgement and supported by the MINI v.6 diagnostic instrument) that significantly elevates the risk of study participation or obscure the evaluation of effectiveness (e.g., psychotic disorders, Major Depressive Disorder, Bipolar Disorder, evidence of dementia or other Cognitive Disorder)
History of one or more suicide attempts (in the last 12 months) or subjects who, in the opinion of the investigator, present a serious risk of suicide, determined also by C-SSRS
Subjects presenting a risk for self-harm or self-injurious behavior(s) or a risk of harming others (in the last 12 months) as judged by the investigator in consultation with the medical monitor
Current severe substance use disorder as determined by the M.I.N.I diagnostic instrument excluding caffeine
Vision or hearing impairment that, in the opinion of the Investigator, might reduce, limit or adversely affect the subject's ability to comply with the requirements of the study or might affect the integrity of the data
Does not own a supported mobile smartphone with a data plan
Any physical, medical (including psychiatric) or other condition that, in the opinion of the investigator, might reduce, limit or adversely affect the subject's ability to comply with the requirements of the study or might affect the integrity of the data
Use of a smartphone app in past for treatment of any psychiatric disorder, including OCD, depression or anxiety disorder
A history of addiction to, dependence on, abuse of, misuse of, distribution of or use of any substance, including alcohol and nicotine, within the past one year

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (1)

BIXINK OC Free

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (1)

BIXINK OC Free

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations