Obsessive Compulsive DisorderNCT01849809
Safety and Effectiveness of Gamma Capsulotomy in Intractable OCD
A study testing Gamma Ventral Capsulotomy in people with Obsessive Compulsive Disorder, run by Butler Hospital at 1 site in United States.
Trial summary
A research study of the effectiveness and safety of gamma knife ventral capsulotomy in patients with severe intractable obsessive-compulsive disorder (OCD). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obsessive Compulsive Disorder
- What is being tested?
- Gamma Ventral Capsulotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 1993to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- OCD, diagnosed by Structured Clinical Interview for DSM-IV (SCID-IV), judged of disabling severity with a Yale-Brown Obsessive Compulsive Scale (YBOCS) score of at least 30 and a Social and Occupational Functioning Assessment Scale (SOFAS) score of 45 or less.
- Persistence of severe symptoms and impairment for five or more years despite: 1. at least three adequate (≥3 months at the maximum tolerated dose) serotonin transporter inhibitor trials (fluoxetine, sertraline, fluvoxamine, paroxetine, citalopram, escitalopram, or clomipramine) alone or in combination with, 2. adequate behavior therapy (≥20 sessions of expert exposure and response prevention), and 3. augmentation of one of the selective SRIs with clomipramine, a neuroleptic, and clonazepam.
- Age between 18 and 65 years.
- Able to understand and comply with instructions.
- Able to give fully informed, written consent in the judgment of the Consent Monitor.
- Either drug free or on a stable drug regimen for at least 6 weeks.
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- Good general health.
- A family member or significant other is available and willing to communicate with the research team if the patient's clinical status worsens.
- The local referring psychiatrist is willing to provide ongoing care.
Who cannot join
- Current or past psychotic disorder.
- Full-scale IQ below 85.
- A clinical history of bipolar mood disorder.
- Any current clinically significant neurological disorder or medical illness affecting brain function, other than tic disorders or Tourette syndrome.
- Any clinically significant abnormality on preoperative magnetic resonance imaging (MRI).
- Inability to undergo presurgical MRI (cardiac pacemaker, pregnancy, metal in body, severe claustrophobia.
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- Current or unstably remitted substance abuse, dependence, or a positive urine toxicology screen.
- Pregnancy and women of childbearing age not using effective contraception.
- Unable to adhere to operational and administrative study requirements (in the investigators' judgment).
- Clinical history of severe personality disorder.
- Imminent risk of suicide (in the investigators' judgment).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Effectiveness of Gamma Capsulotomy in Intractable Obsessive Compulsive Disorder
A research study of the effectiveness and safety of gamma knife ventral capsulotomy in patients with severe intractable obsessive-compulsive disorder (OCD).
- Conditions
- Obsessive Compulsive Disorder
- Being tested
- Gamma Ventral Capsulotomy
- 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.
Gamma Ventral CapsulotomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Gamma Ventral Capsulotomy | Experimental | Not described Receives: Procedure: Gamma Ventral Capsulotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale-Brown Obsessive Compulsive Severity Scale
Measured: Baseline to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2013 (estimated)
- Study startFeb 1993
- Primary completionAug 2011
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obsessive Compulsive DisorderStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven Rasmussen, Butler Hospital
- Investigators
- Steven Rasmussen, MD, Principal investigator, Butler Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01849809
- Sponsor's protocol ID
- IRB#2010-001
- Status last verified
- Aug 2017
- First submitted
- 12 Feb 2013
- Last updated
- 10 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Rasmussen SA, Noren G, Greenberg BD, Marsland R, McLaughlin NC, Malloy PJ, Salloway SP, Strong DR, Eisen JL, Jenike MA, Rauch SL, Baer L, Lindquist C. Gamma Ventral Capsulotomy in Intractable Obsessive-Compulsive Disorder. Biol Psychiatry. 2018 Sep 1;84(5):355-364. doi: 10.1016/j.biopsych.2017.11.034. Epub 2017 Dec 15.
PubMed 29361268
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Gamma Capsulotomy in Intractable Obsessive Compulsive Disorder
- ClinicalTrials.gov ID
- NCT01849809
- Acronym / sponsor ID
- IRB#2010-001
- Conditions
- Obsessive Compulsive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Study start
- Feb 1993
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 9 May 2013 (estimated)
- 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.
A research study of the effectiveness and safety of gamma knife ventral capsulotomy in patients with severe intractable obsessive-compulsive disorder (OCD).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gamma Ventral Capsulotomy | Experimental | Procedure: Gamma Ventral Capsulotomy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- OCD, diagnosed by Structured Clinical Interview for DSM-IV (SCID-IV), judged of disabling severity with a Yale-Brown Obsessive Compulsive Scale (YBOCS) score of at least 30 and a Social and Occupational Functioning Assessment Scale (SOFAS) score of 45 or less.
- Persistence of severe symptoms and impairment for five or more years despite: 1. at least three adequate (≥3 months at the maximum tolerated dose) serotonin transporter inhibitor trials (fluoxetine, sertraline, fluvoxamine, paroxetine, citalopram, escitalopram, or clomipramine) alone or in combination with, 2. adequate behavior therapy (≥20 sessions of expert exposure and response prevention), and 3. augmentation of one of the selective SRIs with clomipramine, a neuroleptic, and clonazepam.
- Age between 18 and 65 years.
- Able to understand and comply with instructions.
- Able to give fully informed, written consent in the judgment of the Consent Monitor.
Key exclusion criteria (11 listed)
- Current or past psychotic disorder.
- Full-scale IQ below 85.
- A clinical history of bipolar mood disorder.
- Any current clinically significant neurological disorder or medical illness affecting brain function, other than tic disorders or Tourette syndrome.
- Any clinically significant abnormality on preoperative magnetic resonance imaging (MRI).
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 |
|---|---|---|
| Gamma Ventral Capsulotomy | Procedure or surgery | Gamma Ventral Capsulotomy |
Primary outcome
Yale-Brown Obsessive Compulsive Severity Scale
Time frame: Baseline to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2017.
- Derived from this study: PubMed 29361268Rasmussen SA, Noren G, Greenberg BD, Marsland R, McLaughlin NC, Malloy PJ, Salloway SP, Strong DR, Eisen JL, Jenike MA, Rauch SL, Baer L, Lindquist C. Gamma Ventral Capsulotomy in Intractable Obsessive-Compulsive Disorder. Biol Psychiatry. 2018 Sep 1;84(5):355-364. doi: 10.1016/j.biopsych.2017.11.034. Epub 2017 Dec 15.
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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. This study is not recruiting at the moment.
Steven Rasmussen, MD principal investigator
Butler Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gamma Ventral Capsulotomy in people with Obsessive Compulsive Disorder, run by Butler Hospital 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 9 inclusion and 11 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: finished, as of the sponsor's last update on 10 Aug 2017. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Yale-Brown Obsessive Compulsive Severity Scale (time frame: Baseline to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01849809, which also lists 1 linked publication.
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 10 Aug 2017.