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Exposure and Response Prevention for Obsessive-Compulsive Disorder
N/A
Recruiting
Led By Edna B Foa, PhD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male and female subjects aged between 18- 45
Be between 18 and 65 years old
Must not have
Current psychotherapy
Patients with prominent suicidal ideation or with a recent suicide attempt
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to approximately 4 weeks later
Awards & highlights
No Placebo-Only Group
Summary
This trial studies how hormonal changes during the menstrual cycle affect the effectiveness of a common OCD therapy called Exposure and Response Prevention (EX/RP). Women will undergo therapy at various points in their cycle, and men will also participate for comparison. The goal is to see if timing therapy with hormonal changes can improve outcomes for women with OCD.
Who is the study for?
This trial is for men and women aged 18-45 with moderate to severe OCD. Women must have regular menstrual cycles and not be on psychotropic meds for the past 12 weeks. Participants can't use certain birth controls, be pregnant, or have conditions that conflict with MRI scans or elevate risks.
What is being tested?
The study tests how hormones during different menstrual cycle phases affect brain response in women undergoing Exposure & Response Prevention (EX/RP) therapy for OCD. It aims to understand hormone influence on the fear extinction network and OCD symptoms.
What are the potential side effects?
Since this trial involves a psychological therapy rather than medication, side effects may include increased anxiety or stress during exposure exercises, temporary worsening of OCD symptoms, and emotional discomfort.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 45 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently undergoing psychotherapy.
Select...
I have had serious thoughts about suicide or attempted it recently.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to approximately 4 weeks later
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to approximately 4 weeks later
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
OCD Symptoms
fMRI
Secondary study objectives
rs fMRI
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Experimental 2Experimental Treatment1 Intervention
Half of female participants will be randomized to receive a brief EX/RP protocol in days 12-22 of the menstrual cycle (late follicular, early luteal phase).
Group II: Experimental 1Experimental Treatment1 Intervention
Half of female participants will be randomized to receive a brief EX/RP protocol within the first 10 days after the start of menstruation (early follicular phase).
Group III: Active ComparatorActive Control1 Intervention
Male participants will receive a brief EX/RP protocol within a 10-day window.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exposure & Response Prevention (EX/RP)
2014
N/A
~80
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Obsessive-Compulsive Disorder (OCD) include Cognitive Behavioral Therapy (CBT) with Exposure and Response Prevention (EX/RP) and selective serotonin reuptake inhibitors (SSRIs). EX/RP works by exposing patients to their fears in a controlled environment and preventing their usual compulsive responses, which helps in reducing the anxiety associated with their obsessions.
SSRIs, on the other hand, increase serotonin levels in the brain, which can help improve mood and reduce anxiety. These treatments are particularly relevant for OCD patients as they target the brain's fear extinction network, which is influenced by hormonal fluctuations during the menstrual cycle.
Understanding these mechanisms is crucial for optimizing treatment timing and improving outcomes for women with OCD.
Commonly asked questions in the treatment of obsessive-compulsive disorder.
Commonly asked questions in the treatment of obsessive-compulsive disorder.
Find a Location
Who is running the clinical trial?
Research Foundation for Mental Hygiene, Inc. / Columbia UniversityUNKNOWN
New York State Psychiatric InstituteOTHER
478 Previous Clinical Trials
153,785 Total Patients Enrolled
25 Trials studying Obsessive-Compulsive Disorder
868 Patients Enrolled for Obsessive-Compulsive Disorder
University of PennsylvaniaLead Sponsor
2,083 Previous Clinical Trials
42,726,652 Total Patients Enrolled
1 Trials studying Obsessive-Compulsive Disorder
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have OCD that is moderate or severe in intensity.Women who do not have regular periods will be excluded.You use birth control that affects your menstrual cycle or have reached menopause.You have a medical or neurological condition that would make it unsafe for you to participate in the entire study.You have a mental health condition that could make it more risky for you to participate in the study or could affect the study outcomes.I have had serious thoughts about suicide or attempted it recently.I haven't taken any psychotropic medication in the last 3 months.I am between 18 and 45 years old.I am currently undergoing psychotherapy.You have been diagnosed with OCD according to the DSM-5 guidelines.I can go without treatment for a while.
Research Study Groups:
This trial has the following groups:- Group 1: Active Comparator
- Group 2: Experimental 1
- Group 3: Experimental 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Obsessive-Compulsive Disorder Patient Testimony for trial: Trial Name: NCT05359562 — N/A