OCD Trial, Recruiting NCT05623306 Sponsor: Casey H. Halpern, M.D. Condition: OCD
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OCD Trial, Recruiting

NCT05623306
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are between 22 and 75 years old at the time of screening.
  • People who have been diagnosed with Obsessive-Compulsive Disorder (OCD) for more than five years, following standard diagnostic guidelines (DSM-5).
  • People whose OCD involves obsessions, compulsions, or both, that take up more than one hour a day or cause significant distress or problems in daily life.
  • People whose OCD symptoms are not caused by a substance (such as a drug or medication) or another medical condition, and are not better explained by a different mental health condition.
  • People with severe OCD symptoms, as measured by a specific rating scale (Y-BOCS I score of 28 or higher) within two weeks before enrolling.
  • People who have not had enough benefit from at least two different SSRI antidepressant medications taken at the highest recommended or tolerated dose for OCD.
  • People who have not had enough benefit from at least one trial of an antipsychotic medication added to their treatment.
  • People who have not had enough benefit from a trial of a medication called clomipramine (unless medically unsuitable for it).
  • People who have not had enough benefit from a specific type of therapy called Cognitive Behavioural Therapy – Exposure and Response Prevention (ERP).
  • People who are willing and able to stay on the same dose of any psychiatric medications for at least eight weeks before the study starts and throughout the entire trial, as determined by the study psychiatrist.
  • People who are willing and able to pause or avoid starting ERP therapy until a later stage of the study, if the study psychiatrist considers this safe.
  • People whose participation in the study is considered to be in their best psychiatric interest, based on a thorough assessment by the study psychiatrist.
  • People who agree to be regularly assessed by a licensed psychiatrist and/or psychologist throughout the study.
  • People who live within six hours' driving distance from the study site and do not plan to move away during the trial (approximately 18–24 months).
  • People who have stable housing and at least two family members or friends who can be listed and verified as emergency contacts.
  • People who are willing and able to provide at least two verifiable emergency contacts and allow the research team to check those contacts before each study visit.
  • People who are able to understand study instructions and complete assessments in English, in the opinion of the study investigator.
  • People who are willing and able to follow all study requirements, including attending visits and keeping to the study schedule, in the opinion of the study investigator.
  • People who are willing and able to give written permission for the research team and treating clinicians to communicate with each other.
  • People who are willing and able to provide written informed consent to participate.

Who may not be able to join:

  • People who have another primary psychiatric diagnosis (as their main condition) according to standardised diagnostic interviews, including Hoarding Disorder. (People with a secondary psychiatric diagnosis may still be considered, except where noted below.)
  • People who have a diagnosis of a severe Personality Disorder, or who have been hospitalised specifically because of Borderline Personality Disorder, in the opinion of the study investigator.
  • People who have ever been diagnosed with Bipolar I or Bipolar II Disorder.
  • People who have had an active episode of Anorexia Nervosa, Bulimia Nervosa, or Binge Eating Disorder within the past five years.
  • People who have ever been diagnosed with a primary psychotic disorder, such as Schizophrenia or Schizoaffective Disorder.
  • People who have had an active episode of a mood disorder with psychotic features within the past two years.
  • People considered to be at high risk of suicide, based on a standardised rating scale and clinician assessment, or who have attempted suicide in the past twelve months requiring hospitalisation, or whose current situation requires inpatient care in the investigator's judgement.
  • People who have been treated for dependency on, addiction to, or misuse of any illegal substance or alcohol within the past two years (this does not include nicotine or caffeine).
  • People with a history of a head injury involving loss of consciousness for more than five minutes, lasting after-effects that had not fully resolved at least one year before screening, an abnormality on a brain scan linked to the injury, or more than one concussion or traumatic brain injury within the past two years.
  • People who have certain permanent implants, including cardiac implants (such as a pacemaker), brain implants (such as aneurysm clips, stimulators, or cochlear implants), or implanted medical pumps.
  • People who require diathermy treatments (a type of heat-based medical therapy).
  • People with hearing loss that, in the opinion of the study investigator or a relevant specialist, may affect their ability to participate fully or may affect the reliability of study data.
  • People who have any metal or metallic particles anywhere in the head, except inside the mouth.
  • People who are pregnant at the time of screening or who become pregnant during the approximately three-year course of the study. Acceptable methods of contraception are specified by the trial and include established hormonal contraceptives, intrauterine devices, surgical sterilisation, documented vasectomy, or true abstinence consistent with the person's usual lifestyle. Barrier methods alone (such as condoms or diaphragms) are not considered sufficient on their own.
  • People with a history of involuntary movements, in the opinion of the study investigator or a neuro-radiologist.
  • People with a history of excessive or prolonged bleeding, or specific abnormal blood clotting test results (confirm details with trial site).
  • People with an allergy to gadolinium (a contrast agent used in MRI scans).
  • People who are unable to safely undergo an MRI or CT scan.
  • People with any past or present medical condition, disease, disorder, or injury that, in the study investigator's opinion, may prevent full participation in the study or affect the reliability of the study results.
  • People who are currently participating in other research that may interfere with this study's goals or timeline, as determined by the study investigator.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: 215-829-6720

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Casey H. Halpern, M.D.
Registry
ClinicalTrials.gov
Start date
13 April 2023
Est. completion
1 April 2030

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Primary Feasibility Endpoint #1 - OCD Relevant Network; Primary Feasibility Endpoint #2 - Stimulation Target That Acutely Improves OCD Symptoms; Primary Feasibility Endpoint #3 - Willingness to Continue with DBS Stage 2; Primary Feasibility Endpoint #4 - Acute Symptomatic Improvement; Primary Efficacy Endpoint - Treatment Response; Primary Safety Endpoint - Serious Adverse Events

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov