Obsessive-Compulsive DisorderPhase 1/2NCT04131829
Brain Network Changes Accompanying and Predicting Responses to Pharmacotherapy in OCD
A Phase 1/2 study testing Fluoxetine - immediate treatment and Fluoxetine - delayed treatment in people with Obsessive-Compulsive Disorder, run by Yale University at 1 site in United States.
Trial summary
The proposed randomized, double-blind research study will use functional magnetic resonance neuroimaging using state-of-the-art HCP acquisition protocols and analytic pipelines, to identify predictors and correlates of response to an accepted first-line pharmacological treatment for obsessive-compulsive disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Fluoxetine - immediate treatment and Fluoxetine - delayed treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2019to Sep 2027
- Phase
- Phase 1/2
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Inclusion criteria for all groups will include: (i) Adults, Men and women will be included, in a 1:1 ratio; and efforts will be made to recruit racial and ethnic subgroups. Groups will be further matched on age, handedness; and later, in analysis, on educational status and smoking history.
- signed informed consent, approved by the Yale Human Investigations Committee; and (iii) ability and willingness to participate in all study procedures, including clinical assessments and fMRI scans.
- Additional inclusion criteria:
- OCD Participants:
- a DSM diagnosis of OCD, established as detailed above; (ii) a baseline Y-BOCS of ≥16; (iii) no current psychoactive medication, with the exception of the occasional use of a PRN medication for sleep; (iv) treatment seeking, and clinically appropriate for fluoxetine pharmacotherapy; (v) for women of childbearing potential, not pregnant or intending to become pregnant, and willing to use reliable birth control over the course of the study, either prescribed contraceptive (oral contraceptive, injectable, or implant) or one barrier method (e.g. diaphragm with spermicide, intrauterine device, cervical cap). Women of childbearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy tests at the study baseline and on each scan day appointment prior to the MRI scan.
- Healthy Control Participants:
- no current DSM diagnosis (by clinician interview confirmed by SCID or MINI); (ii) no documented or clinically suspected family history in a first- or second- degree relative of OCD, Tourette syndrome, hoarding disorder, body dysmorphic disorder, or a compulsive grooming disorder.
Who cannot join
- any unstable medical, psychiatric, or neurological condition (including active or otherwise problematic suicidality) that may necessitate urgent treatment; (ii) any substance use disorder within the past 6 months; (iii) use of psychotropic medications within the past 8 weeks, with the exception of occasional use of a sleep aid or analgesic; (iv) use of an as-needed sleep aid or prescription analgesic within 3 days of the scan; (v) any history of a primary psychotic disorder or of mania; (vi) any evidence of substance use on urine toxicology testing; (vii) any major neurological disease or history of major head trauma, including concussion with extended loss of consciousness; (viii) pregnancy; (ix) any metal in the body or other contraindication to MRI scanning; (x) severe claustrophobia, back pain, or other condition that may make an extended MR scan difficult or lead to excessive movement during the scan.
- Additional exclusion criteria:
- OCD Participants:
- past allergy or adverse reaction to fluoxetine or another SSRI, or other clinical contraindication to fluoxetine pharmacotherapy; (ii) documented nonresponse to a past trial of fluoxetine of appropriate dose (≥40 mg/dy) and duration (≥12 weeks).
- Patients taking Coumadin or Monoamine oxidase inhibitors (MAOIs) will be excluded from the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Yale OCD Research Clinic - CMHC/CNRU, 34 Park ST
New Haven, Connecticut, 06519
Stephen Kichuk, MPH, 203-974-7534, stephen.kichuk@yale.edu
OCD Research, 1-855-623-9253, ocd.research@yale.edu
About this study
The proposed randomized, double-blind research study will use functional magnetic resonance neuroimaging using state-of-the-art HCP acquisition protocols and analytic pipelines, to identify predictors and correlates of response to an accepted first-line pharmacological treatment for obsessive-compulsive disorder.
Read the detailed description
The proposed study intends to recruit 2 groups:
- Matched healthy control participants will be imaged with one fMRI at baseline as a no-treatment comparison group; and
- a randomized, double-blind group of unmedicated OCD participants who will be assigned to begin either immediate or placebo-delayed treatment, and who will be imaged with fMRIs at baseline and over the course of treatment with a selective serotonin reuptake inhibitor (SSRI), fluoxetine.
Hypothesis-driven analyses and exploratory analyses will be performed in parallel.
This study will address the following Specific Aims:
- Identification of neural dysconnectivity associated with OCD symptomatology.
- Characterizing neural markers of clinical response to SSRI pharmacotherapy.
- Mapping neural predictors of clinical response to pharmacotherapy.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Fluoxetine - immediate treatment, Fluoxetine - delayed treatment
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoxetine - immediate treatmentDrug
Also called fluoxetine, prozac
Following the Baseline assessment, OCD subjects will be randomized to receive either immediate fluoxetine monotherapy or delayed fluoxetine, after a 6-week placebo lead-in.
Fluoxetine - delayed treatmentDrug
Also called fluoxetine, prozac
Following the Baseline assessment, OCD subjects will be randomized to receive either immediate fluoxetine monotherapy or delayed fluoxetine, after a 6-week placebo lead-in.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | No intervention | The healthy control group will be an age matched sample of unmedicated healthy adults who will be recruited and imaged once at baseline and the data compared with that of OCD subjects at baseline. |
| OCD Group | Experimental | The OCD group will comprise of unmedicated individuals with clinically significant OCD symptoms. OCD Subjects will be randomized, double-blind, to receive immediate or delayed (by 6 weeks as a placebo lead-in) pharmacotherapy. Receives: Drug: Fluoxetine - immediate treatment; Drug: Fluoxetine - delayed treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obsessive-compulsive severity change
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS);72,73 -This is a checklist and Clinician administered - 10 item severity scale, from none to extreme. Total severity score range is 0 to 40. This will be presented as % improvement in Y-BOCS as a continuous measure of treatment response, rather than an artificially dichotomized measure of 'response', in all analyses. This the primary outcome measure of change across the study treatment and scans.
Measured: 18 weeks
Secondary outcomes (7)
Tic severity change
Yale Global Tic Severity Scale (YGTSS) will be used to measure Tic severity. It is a clinician administered instrument with a score from 0 to 25- 25 being the most severe.
Measured: 18 weeks
Beck Depression Inventory-II
Beck Depression Inventory-II (BDI-II);82 21 items to assess intensity of depression.
Measured: 18 weeks
Anxiety
Beck Anxiety Inventory (BAI);83 21 item self report on a 4 point Likert scale - 0 (not at all) to 3 (severely).
Measured: 18 weeks
Obsessive-compulsive concerns
Dimensional Obsessive-Compulsive Scale (DOCS);84 20 questions, asks about 4 categories of obsessive-compulsive concerns (each consists of 5 items scored on a Likert scale of 0-no symptoms to 4 - extreme symptoms) over the previous month.
Measured: 18 weeks
Magical ideation
Magical Ideation Scale (MIS);86 30 item true / false scale, assessing erroneous beliefs based on magical thinking.
Measured: 18 weeks
Sensory phenomena
University of São Paulo Sensory Phenomena Scale (USP-SPS);87
Measured: 18 weeks
"Not Just Right" experiences and sensations in OCD
Not Just Right Experiences Questionnaire Revised (INC).88 19 Questions: Rate 10 NJR Experiences; Choose most recent one; Identify how long ago it occurred; then complete 7 dimensional ratings of that NJRE: frequency, intensity, immediate distress, delayed distress, rumination, urge to respond, and responsibility to do something about the NJRE, from 1 (absence) to 7 (extreme level /or within the past day).
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start14 Oct 2019
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 80 OCD patients and 40 healthy participants matched on demographics will be recruited and asked to complete Structural (sMRI) and Functional (fMRI) Magnetic Resonance Imaging. Patients with OCD will be randomized to immediate monotherapy or 6-week placebo-delayed monotherapy, with fluoxetine.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Christopher Pittenger, MD, PhD, Principal investigator, Professor of Psychiatry; Director, Yale OCD Research Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04131829
- Sponsor's protocol ID
- 2000023688
- Other IDs
- 1R01MH116038-01A1, 1K24MH121571-01
- Status last verified
- Sep 2026
- First submitted
- 16 Oct 2019
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Network Changes Accompanying and Predicting Responses to Pharmacotherapy in OCD
- ClinicalTrials.gov ID
- NCT04131829
- Acronym / sponsor ID
- 2000023688
- Conditions
- Obsessive-Compulsive Disorder
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 18 Oct 2019 (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.
The proposed randomized, double-blind research study will use functional magnetic resonance neuroimaging using state-of-the-art HCP acquisition protocols and analytic pipelines, to identify predictors and correlates of response to an accepted first-line pharmacological treatment for obsessive-compulsive disorder.
Detailed description
The proposed study intends to recruit 2 groups:
- Matched healthy control participants will be imaged with one fMRI at baseline as a no-treatment comparison group; and
- a randomized, double-blind group of unmedicated OCD participants who will be assigned to begin either immediate or placebo-delayed treatment, and who will be imaged with fMRIs at baseline and over the course of treatment with a selective serotonin reuptake inhibitor (SSRI), fluoxetine.
Hypothesis-driven analyses and exploratory analyses will be performed in parallel.
This study will address the following Specific Aims:
- Identification of neural dysconnectivity associated with OCD symptomatology.
- Characterizing neural markers of clinical response to SSRI pharmacotherapy.
- Mapping neural predictors of clinical response to pharmacotherapy.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 80 OCD patients and 40 healthy participants matched on demographics will be recruited and asked to complete Structural (sMRI) and Functional (fMRI) Magnetic Resonance Imaging. Patients with OCD will be randomized to immediate monotherapy or 6-week placebo-delayed monotherapy, with fluoxetine.
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | No intervention | –The healthy control group will be an age matched sample of unmedicated healthy adults who will be recruited and imaged once at baseline and the data compared with that of OCD subjects at baseline. |
| OCD Group | Experimental | Drug: Fluoxetine - immediate treatment, Drug: Fluoxetine - delayed treatmentThe OCD group will comprise of unmedicated individuals with clinically significant OCD symptoms. OCD Subjects will be randomized, double-blind, to receive immediate or delayed (by 6 weeks as a placebo lead-in) pharmacotherapy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Inclusion criteria for all groups will include: (i) Adults, Men and women will be included, in a 1:1 ratio; and efforts will be made to recruit racial and ethnic subgroups. Groups will be further matched on age, handedness; and later, in analysis, on educational status and smoking history.
- signed informed consent, approved by the Yale Human Investigations Committee; and (iii) ability and willingness to participate in all study procedures, including clinical assessments and fMRI scans.
- Additional inclusion criteria:
- OCD Participants:
- Healthy Control Participants:
Key exclusion criteria (5 listed)
- Additional exclusion criteria:
- OCD Participants:
- Patients taking Coumadin or Monoamine oxidase inhibitors (MAOIs) will be excluded from the study.
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 |
|---|---|---|
| Fluoxetine - immediate treatmentAlso: fluoxetine, prozacFollowing the Baseline assessment, OCD subjects will be randomized to receive either immediate fluoxetine monotherapy or delayed fluoxetine, after a 6-week placebo lead-in. | Drug | OCD Group |
| Fluoxetine - delayed treatmentAlso: fluoxetine, prozacFollowing the Baseline assessment, OCD subjects will be randomized to receive either immediate fluoxetine monotherapy or delayed fluoxetine, after a 6-week placebo lead-in. | Drug | OCD Group |
Primary outcome
Obsessive-compulsive severity change
Time frame: 18 weeks
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS);72,73 -This is a checklist and Clinician administered - 10 item severity scale, from none to extreme. Total severity score range is 0 to 40. This will be presented as % improvement in Y-BOCS as a continuous measure of treatment response, rather than an artificially dichotomized measure of 'response', in all analyses. This the primary outcome measure of change across the study treatment and scans.
7 secondary outcomes
Tic severity change
Time frame: 18 weeks
Beck Depression Inventory-II
Time frame: 18 weeks
Anxiety
Time frame: 18 weeks
Obsessive-compulsive concerns
Time frame: 18 weeks
Magical ideation
Time frame: 18 weeks
Sensory phenomena
Time frame: 18 weeks
"Not Just Right" experiences and sensations in OCD
Time frame: 18 weeks
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 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Christopher Pittenger, MD, PhD principal investigator
Professor of Psychiatry; Director, Yale OCD Research Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Fluoxetine - immediate treatment and Fluoxetine - delayed treatment in people with Obsessive-Compulsive Disorder, run by Yale University at 1 site 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 5 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 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Yale OCD Research Clinic (1-855-623-9253, ocd.research@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obsessive-compulsive severity change (time frame: 18 weeks). 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 Sep 2026.