What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for Obsessive-Compulsive Disorder (OCD) include Cognitive Behavioral Therapy (CBT) with Exposure and Response Prevention (EX/RP) and serotonin reuptake inhibitors (SRIs). CBT, particularly EX/RP, is generally well-tolerated and not associated with significant adverse effects. However, SRIs can cause side effects such as nausea, headache, sexual dysfunction, and insomnia. Combining CBT with SRIs is often recommended for severe cases or when monotherapy is insufficient. Hormonal fluctuations during the menstrual cycle can affect the efficacy of EX/RP therapy, potentially impacting the brain's fear extinction network.

What prior FDA approvals exist?

The FDA has approved several selective serotonin reuptake inhibitors (SSRIs) for the treatment of Obsessive-Compulsive Disorder (OCD), including fluoxetine, sertraline, fluvoxamine, and paroxetine. These medications are often first-line treatments due to their efficacy in reducing OCD symptoms. Additionally, clomipramine, a tricyclic antidepressant, has also been approved for OCD. Augmentation strategies, such as combining SSRIs with cognitive-behavioral therapy (CBT) that includes exposure and response prevention (EX/RP), have shown effectiveness, particularly in patients with partial response to SSRIs alone. While hormonal treatments like triptorelin are being studied for their potential to enhance the effectiveness of EX/RP therapy by affecting the fear extinction network, they are not yet FDA-approved for OCD.

What other types of research exist?

Promising novel alternatives for treating OCD in 2024 could include hormonal treatments that stabilize hormone levels or medications targeting serotonin transporters. These approaches may help mitigate the impact of hormonal fluctuations on the fear extinction network, potentially enhancing the effectiveness of EX/RP therapy.

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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

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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to approximately 4 weeks later for reporting.

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

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

0 / 3Eligibility criteria met

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.