OCDNCT05359562
How Hormones and Exposure and Response Prevention (EX/RP) Affect the Brain of People With OCD
A study testing Exposure & Response Prevention (EX/RP) in people with OCD, run by University of Pennsylvania at 2 sites in United States.
Trial summary
Studies show that hormones affect the brain's fear extinction network, which is relevant for therapy involving exposure and response prevention (EX/RP), a first-line treatment for obsessive compulsive disorder (OCD). Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- OCD
- What is being tested?
- Exposure & Response Prevention (EX/RP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Jun 2022to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Diagnosis of OCD;
- Male and female subjects aged between 18- 45;
- Women must be menstruating and regularly cycling
- Ability to tolerate a treatment-free period;
- No psychotropic medication in the past 12 weeks
- At entry, at least moderate severity OCD
- Willingness and ability to give written informed consent after full explanation of study procedures.
Who cannot join
- Use of birth control (oral contraception or IUD) that affects the menstrual cycle, or menopause.
- Pregnancy. Women of childbearing potential will be required to sign a statement indicating their intention to avoid pregnancy during the study.
- Neurologic or medical condition that would prevent safe participation in the full study protocol.
- Any contradiction to magnetic resonance imaging (e.g., metallic implants or devices).
- Comorbid psychiatric conditions that significantly elevate the risks associated with study participation or confound results.
- Patients with prominent suicidal ideation or with a recent suicide attempt.
- Current psychotherapy
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
New York State Psychiatric Institute
New York, New York, 10032
Sara Rose Shannon, BS, MS, 646-774-8082, SaraRose.Shannon@nyspi.columbia.edu
Stephanie Grimaldi, 646-774-8062, Stephanie.Grimaldi@nyspi.columbia.edu
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Bryanna Mackey, BA, 215-746-3344, Bryanna.Mackey@Pennmedicine.upenn.edu
Jeremy Tyler, PsyD, 215-746-3349, jeremyty@pennmedicine.upenn.edu
About this study
Official title: Harnessing Hormonal Variation to Probe Neural Mechanisms and Optimize CBT Outcomes for OCD
Studies show that hormones affect the brain's fear extinction network, which is relevant for therapy involving exposure and response prevention (EX/RP), a first-line treatment for obsessive compulsive disorder (OCD). This study will examine the effect of delivering EX/RP to women during different phases in their menstrual cycle to determine the effects of hormones on the fear extinction network and on their OCD symptoms.
Read the detailed description
This study involves neuroimaging and a brief EX/RP protocol. The investigators will recruit both male and female participants. All participants will complete neuroimaging, hormonal assays and symptom ratings before and after a brief course of EX/RP. Female participants will be randomized to complete brief EX/RP during distinct phases of their menstrual cycles. This design will allow the investigators to study the effects of hormonal variation during the menstrual cycle and sex on the fear extinction network and on EX/RP outcome. The long-term goal is to optimize EX/RP for individuals suffering from OCD. Men will also be recruited for this study to further explore biological sex differences. The results will elucidate treatment mechanisms and could lead to personalized treatment recommendations for women with OCD.
- Conditions
- OCD
- Being tested
- Exposure & Response Prevention (EX/RP)
- Keywords
- OCD, Exposure and Ritual Prevention, Extinction Learning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure & Response Prevention (EX/RP)Behavioural
Exposure and Response Prevention (EX/RP) is a type of Cognitive Behavioral Treatment for treating OCD. This is a brief protocol consisting of 8 sessions of exposure and Response Prevention (EX/RP). This protocol includes two psychoeducation/planning sessions, followed by six exposure sessions.
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator | Active comparator | Male participants will receive a brief EX/RP protocol within a 10-day window. Receives: Behavioral: Exposure & Response Prevention (EX/RP) |
| Experimental 1 | Experimental | 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). Receives: Behavioral: Exposure & Response Prevention (EX/RP) |
| Experimental 2 | Experimental | 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). Receives: Behavioral: Exposure & Response Prevention (EX/RP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRI
Slope of change in brain activation (fMRI)
Measured: Baseline to approximately 4 weeks later
OCD Symptoms
Slope of change in Obsessive Compulsive Symptom Severity (Yale-Brown Obsessive Compulsive Scale)
Measured: Baseline to approximately 4 weeks later
Secondary outcomes (1)
rs fMRI
Slope of change in resting state functional connectivity (fMRI)
Measured: Baseline to approximately 4 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start15 Jun 2022
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OCDStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- New York State Psychiatric Institute, New York University, Columbia University, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Lily Brown, PhD, Principal investigator, University of PennsylvaniaHelen B Simpson, MD, PhD, Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05359562
- Sponsor's protocol ID
- 1R01MH121608-01A1
- Other IDs
- 1R01MH121597-01A1
- Status last verified
- Jul 2026
- First submitted
- 28 Apr 2022
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harnessing Hormonal Variation to Probe Neural Mechanisms and Optimize CBT Outcomes for OCD
- ClinicalTrials.gov ID
- NCT05359562
- Acronym / sponsor ID
- 1R01MH121608-01A1
- Conditions
- OCD
- Keywords
- OCD, Exposure and Ritual Prevention, Extinction Learning
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- New York State Psychiatric Institute, New York University, Columbia University, National Institute of Mental Health (NIMH)
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 4 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Studies show that hormones affect the brain's fear extinction network, which is relevant for therapy involving exposure and response prevention (EX/RP), a first-line treatment for obsessive compulsive disorder (OCD). This study will examine the effect of delivering EX/RP to women during different phases in their menstrual cycle to determine the effects of hormones on the fear extinction network and on their OCD symptoms.
Detailed description
This study involves neuroimaging and a brief EX/RP protocol. The investigators will recruit both male and female participants. All participants will complete neuroimaging, hormonal assays and symptom ratings before and after a brief course of EX/RP. Female participants will be randomized to complete brief EX/RP during distinct phases of their menstrual cycles. This design will allow the investigators to study the effects of hormonal variation during the menstrual cycle and sex on the fear extinction network and on EX/RP outcome. The long-term goal is to optimize EX/RP for individuals suffering from OCD. Men will also be recruited for this study to further explore biological sex differences. The results will elucidate treatment mechanisms and could lead to personalized treatment recommendations for women with OCD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active Comparator | Active comparator | Behavioral: Exposure & Response Prevention (EX/RP)Male participants will receive a brief EX/RP protocol within a 10-day window. |
| Experimental 1 | Experimental | Behavioral: Exposure & Response Prevention (EX/RP)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). |
| Experimental 2 | Experimental | Behavioral: Exposure & Response Prevention (EX/RP)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). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Diagnosis of OCD;
- Male and female subjects aged between 18- 45;
- Women must be menstruating and regularly cycling
- Ability to tolerate a treatment-free period;
- No psychotropic medication in the past 12 weeks
Key exclusion criteria (7 listed)
- Use of birth control (oral contraception or IUD) that affects the menstrual cycle, or menopause.
- Pregnancy. Women of childbearing potential will be required to sign a statement indicating their intention to avoid pregnancy during the study.
- Neurologic or medical condition that would prevent safe participation in the full study protocol.
- Any contradiction to magnetic resonance imaging (e.g., metallic implants or devices).
- Comorbid psychiatric conditions that significantly elevate the risks associated with study participation or confound results.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure & Response Prevention (EX/RP)Exposure and Response Prevention (EX/RP) is a type of Cognitive Behavioral Treatment for treating OCD. This is a brief protocol consisting of 8 sessions of exposure and Response Prevention (EX/RP). This protocol includes two psychoeducation/planning sessions, followed by six exposure sessions. | Behavioural | Active Comparator, Experimental 1, Experimental 2 |
Primary outcome
fMRI
Time frame: Baseline to approximately 4 weeks later
Slope of change in brain activation (fMRI)
OCD Symptoms
Time frame: Baseline to approximately 4 weeks later
Slope of change in Obsessive Compulsive Symptom Severity (Yale-Brown Obsessive Compulsive Scale)
1 secondary outcome
rs fMRI
Time frame: Baseline to approximately 4 weeks later
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lily Brown, PhD principal investigator
University of Pennsylvania
Helen B Simpson, MD, PhD principal investigator
New York State Psychiatric Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure & Response Prevention (EX/RP) in people with OCD, run by University of Pennsylvania at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bryanna Mackey (2157463344, Bryanna.Mackey@Pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fMRI (time frame: Baseline to approximately 4 weeks later). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.