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Obsessive-Compulsive DisorderPhase 4NCT00640133

Effectiveness of Deep Brain Stimulation for Treating People With Treatment Resistant Obsessive-Compulsive Disorder

A Phase 4 study testing Active DBS in people with Obsessive-Compulsive Disorder, run by Butler Hospital at 9 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study will evaluate the safety and effectiveness of deep brain stimulation in treating people with severe and otherwise treatment-resistant obsessive-compulsive disorder. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Obsessive-Compulsive Disorder
What is being tested?
Active DBS
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
27 participants
Where
9 sitesUnited States
Study dates
Mar 2008to 1 Dec 2024
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Obsessive-compulsive disorder (OCD), diagnosed by Structured Clinical Interview for DSM-IV (SCID-IV)
  • Presence of disabling severity, as assessed by a Yale-Brown Obsessive Compulsive Scale (YBOCS) score of at least 30
  • Impaired functioning, indicated by a Global Assessment of Functioning (GAF) score of 45 or less
  • Documented highly treatment refractory illness; the documentation must demonstrate persistence of severe symptoms and impairment for 5 or more years despite at least three first-line and two second-line treatments, as follows:
  • at least three adequate trials of, or documented intolerance to, different serotonin transporter inhibitors (e.g., fluoxetine, sertraline, fluvoxamine, paroxetine, citalopram, escitalopram, clomipramine) for at least 3 months at the maximum tolerated dose. These trials may include any of the agents above, but must include an adequate course of clomipramine, either alone or in combination with a more selective serotonin transporter inhibitor;
  • augmentation of one of the selective serotonin transporter inhibitors with clomipramine, and a neuroleptic (each for at least 2 weeks); and
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  • adequate behavior therapy (more than 20 sessions of exposure and response prevention by a therapist with substantial expertise in OCD treatment as determined by the investigators) with at least one of these trials and tried in combination with medication therapy
  • Either drug free or on a stable drug regimen for at least 6 weeks before study entry
  • General good overall health
  • If possible, has a family member or significant other who sees the participant regularly, can communicate with the study team as needed, and, if necessary, can attend study visits
  • Local referring psychiatrist willing to provide ongoing care during and after the trial, to work closely with the research team, and to agree that the study psychiatrist will prescribe medications during the 3-month masked phase
  • Platelet count greater than 125,000 per cubic millimeter and a prothrombin time and partial thromboplastin time within normal limits

Who cannot join

  • Current or past psychotic disorder
  • Full-scale IQ below 75 on the Wechsler Abbreviated Scale of Intelligence (WASI), or cognitive impairment that would affect a participant's ability to give informed consent or provide interview or self-report data reliably, as determined by the Consent Monitor and the site psychiatrist.
  • A clinical history of bipolar mood disorder
  • Any current clinically significant neurological disorder or medical illness affecting brain function, other than a tic disorder
  • Any clinically significant abnormality on preoperative MRI
  • Any labeled DBS contraindication, inability to undergo presurgical MRI (e.g., cardiac pacemaker, pregnancy, metal in body, severe claustrophobia), infection, coagulopathy, inability to undergo an awake operation, significant cardiac risk factors, or other medical risk factors for surgery
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  • Current or unstable remitted substance abuse or dependence
  • Positive urine toxicology screen for substance abuse
  • Pregnant and/or woman of childbearing age not using effective forms of birth control
  • Clinical history of severe personality disorder
  • An inability to control suicide attempts, imminent risk of suicide in the investigator's judgment, or a history of serious suicidal behavior, which is defined using the Columbia-Suicide Severity Rating Scale (C-SSRS) as either (1) one or more actual suicide attempts in the 3 years before study entry with the lethality rated at 3 or higher, or (2) one or more interrupted suicide attempts with a potential lethality judged to result in serious injury or death
  • Current diagnosis of body dysmorphic disorder
  • Evidence of dementia of other significant cognitive impairment on neuropsychological evaluation

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • University of Chicago

    Chicago, Illinois, 60637

  • The Cleveland Clinic

    Cleveland, Ohio, 44195

  • University of Florida

    Gainesville, Florida, 32610

  • Butler Hospital

    Providence, Rhode Island, 02906

  • Kaiser Permanente Redwood City Hospital

    Redwood City, California, 94063

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • George Washington University Hospital

    Washington D.C., District of Columbia, 20037

  • Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: Controlled Trial of Deep Brain Stimulation for Obsessive-Compulsive Disorder

This study will evaluate the safety and effectiveness of deep brain stimulation in treating people with severe and otherwise treatment-resistant obsessive-compulsive disorder.

Read the detailed description

Obsessive-compulsive disorder (OCD) is a chronic and debilitating illness that affects between 2% and 3% of adults in the United States. People with OCD often experience persistent unwanted thoughts and carry out ritual-like behaviors to rid themselves of these obsessive thoughts. Additionally, OCD symptoms are usually tied with feelings of intense anxiety and functional impairment, making it important for people with OCD to seek effective treatment. Although there are currently many treatment options for OCD, including psychotherapy and medications such as serotonin reuptake inhibitors, between 40% and 60% of people with OCD only partially respond or do not respond at all to these treatment methods. Given the large percentage of people who do not respond to aggressive conventional treatments, alternative options are necessary for people with treatment-resistant OCD. Deep brain stimulation (DBS) is a procedure that involves the use of thin wires to carry electric current to parts of the brain associated with producing OCD symptoms. DBS has been effectively and safely used to treat movement disorders, such as Parkinson's disease, and may be beneficial in reducing OCD symptom severity. This study will evaluate the safety and effectiveness of DBS in treating people with severe and otherwise treatment-resistant OCD.

Study participation through follow-up will last 4 years. Participants will be allowed to remain on any pre-surgical medications or behavioral therapy programs throughout the study. Before surgery, all participants will undergo a 3- to 4-day series of initial tests and examinations that will include a physical and neurological examination; blood and urine screening tests; an electrocardiogram (EKG); an electroencephalography (EEG); and detailed psychological testing, including tests of perception, learning, and memory. The EEGs may be performed again after surgery to measure potential changes in brain electrical activity due to DBS.

On the day of the surgery, participants will take a low dose of anxiety medication, have a metal frame fixed to their heads for support during surgery, and undergo a magnetic resonance imaging (MRI) scan to determine where to place the stimulating wires. After being injected with a local anesthetic, participants will undergo the first part of the operation, which will involve the implantation of neurostimulators in the ventral caudate/ventral striatum brain region. For the second part of the operation, after participants are administered general anesthesia, they will have the implantable neurostimulators (INSs) placed in their chests and the connecting wires to the brain placed under their skin. The entire surgical procedure will take 3 to 4 hours, with a 1- to 2-day post-operative hospital stay for recovery. During the post-operative stay, participants will undergo x-rays and a computed tomography (CT) scan of the head.

Two to 3 weeks after surgery, participants will be divided randomly into either a group that receives DBS immediately or a group that first receives sham DBS and then active DBS after 3 months. The level of stimulation will be adjusted individually and on the basis of each participant's response to the stimulation. Participants will complete rating forms, a clinical evaluation, and a check of the stimulators every month for the first 3 months, then at least every 3 months for the rest of the year, and then every 6 months for the remaining years of the study. On the Year 1 visit, participants will repeat the baseline detailed psychological testing. Periodically throughout the 4-year study, staff will contact participants by phone to ask about OCD symptoms, mood, anxiety, and possible side effects. Also throughout the study, participants will need to have the INSs replaced every 5 to 16 months on average.

Participants will also be invited to participate in a related study that involves positron emission tomography (PET) scanning to determine how the stimulation changes activity in the brain. Participation in the separate PET study is optional and will not affect current study participation.

Being tested
Active DBS, Sham DBS
Keywords
Deep Brain Stimulation, Treatment Refractory, Ventral Internal Capsule/Ventral Striatum, Neurosurgery, Neuroimaging
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.

  • Active DBSDevice

    Also called Activa Deep Brain Stimulation System (Medtronic, Inc.), Implantable Neurostimulator (INS)

    In DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will adjust the settings of the electrical stimulation to optimize treatment for each participant. After a post-operative rest, participants will receive immediate DBS treatment throughout.

  • Sham DBSDevice

    Also called Activa Deep Brain Stimulation System (Medtronic, Inc.), Implantable Neurostimulator (INS)

    In DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will mimic adjusting the settings of the electrical stimulation. After a post-operative rest, participants will receive DBS treatment after a delay of several months. Afterwards, all participants will receive open-label long-term DBS.

Study groups in NCT00640133
Study groupRoleWhat they receive
Active DBSActive comparatorParticipants will receive deep brain stimulation.
Receives: Device: Active DBS
Sham DBSSham comparatorParticipants will receive sham deep brain stimulation for several months and then active deep brain stimulation thereafter.
Receives: Device: Active DBS; Device: Sham DBS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Yale-Brown Obsessive-Compulsive Scale (YBOCS Severity Ratings)

    The Yale-Brown Obsessive-Compulsive Scale (YBOCS) is a 10 question evaluator-administered measure assessing the severity of obsessions and compulsions over the past week. Obsession and compulsion severity are evaluated separately (ratings from 0-20 for each category) with total scores ranging from 0-40. Higher scores for obsessions, compulsions and total score indicate more severe symptoms over the past week.

    Measured: YBOCS total score observed means at month-12

  2. Global Assessment of Functioning Scale (GAF)

    A numeric scale (0 through 100) used to rate the social, occupational, and psychological overall functioning during the week of poorest functioning in the past month. Higher scores indicate a higher level of functioning, while low scores indicate impaired global functioning.

    Measured: GAF score observed means at month-12

  3. Social and Occupational Functioning Assessment Scale (SOFAS)

    A numeric scale (0 through 100) used to rate the social, occupational, and psychological functioning during the week of poorest functioning in the past month. Higher scores indicate higher levels of social and occupational functioning, while low scores represent social and occupational impairment.

    Measured: SOFAS score observed means at month-12 time point.

Secondary outcomes (5)

  1. Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)

    The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) is a self-administered measure to assess the degree of enjoyment and satisfaction experienced by participants in various areas of daily functioning. We used the 16-item short form with total scores ranging from 16-80. Higher scores indicate greater satisfaction experienced during the past week.

    Measured: QLESQ total score observed means at month-12 time point.

  2. Montgomery-Asberg Depression Rating Scale (MADRS)

    The Montgomery Asberg Depression Rating Scale (MADRS) is an interviewer-administered measure assessing the ten symptoms of depression most sensitive to change. Apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts are assessed and total scores range from 0-60 with higher scores representing the presence of more severe depression over the past week.

    interviewer-administered measure assessing

    Measured: MADRS total score observed means at month-12 time point.

  3. Hamilton Anxiety Rating Scale (HARS)

    Hamilton Anxiety Rating Scale (HARS) is a 14-item test measuring the severity of anxiety symptoms. It provides measures of overall anxiety, psychic anxiety (mental agitation and psychological distress), and somatic anxiety (physical complaints related to anxiety); total scores range from 0-56. Higher scores indicate higher levels of anxiety over the past week.

    Measured: HARS total score observed means at month-12 time point.

  4. Behavioral Activation for Depression Scale (BADS)

    The Behavioral Activation for Depression Scale (BADS) is a 29-item scale that measures the role of aversive controlling stimuli and escape and avoidance behavior in depression, specifically when and how participants become more activated over the course of treatment. Total scores range from 29-203 and lower scores indicate higher levels of escape and avoidance behavior from depression in the past week.

    Measured: Total BADS score observed means at month-12 time point.

  5. Hamilton Depression Rating Scale (HDRS)

    The Hamilton Depression Rating Scale (HDRS) measures the severity of depressive symptoms in adults. The evaluator-administered ratings measure depressed mood, guilt, suicide, insomnia, work/activities, retardation, agitation, psychic and somatic anxiety, genital symptoms, hypochondriasis, and insight during the past week. Total scores range from 0-72 and higher scores indicate the presence of more severe depression over the past week. Note: this measure was only administered at baseline and month-3.

    Measured: Total HDRS score observed means at month-3 time point.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2008 (estimated)
  2. Study startMar 2008
  3. Primary completion24 May 2018
  4. Study completion1 Dec 2024 (estimated)

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00640133
Sponsor's protocol ID
U01MH076179
Other IDs
U01MH076179, DSIR 83-ATSO
Status last verified
Jul 2024
First submitted
17 Mar 2008
Last updated
29 Jul 2024
Data monitoring committee
Yes

Publications

  • Greenberg BD, Malone DA, Friehs GM, Rezai AR, Kubu CS, Malloy PF, Salloway SP, Okun MS, Goodman WK, Rasmussen SA. Three-year outcomes in deep brain stimulation for highly resistant obsessive-compulsive disorder. Neuropsychopharmacology. 2006 Nov;31(11):2384-93. doi: 10.1038/sj.npp.1301165. Epub 2006 Jul 19.

    PubMed 16855529

  • Goodman WK, Price LH, Rasmussen SA, Mazure C, Fleischmann RL, Hill CL, Heninger GR, Charney DS. The Yale-Brown Obsessive Compulsive Scale. I. Development, use, and reliability. Arch Gen Psychiatry. 1989 Nov;46(11):1006-11. doi: 10.1001/archpsyc.1989.01810110048007.

    PubMed 2684084

  • Endicott J, Nee J, Harrison W, Blumenthal R. Quality of Life Enjoyment and Satisfaction Questionnaire: a new measure. Psychopharmacol Bull. 1993;29(2):321-6.

    PubMed 8290681

  • Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry. 1979 Apr;134:382-9. doi: 10.1192/bjp.134.4.382.

    PubMed 444788

  • Kanter, J. W., Rusch, L. C., Busch, A. M., & Sedivy, S. K. (2009). Validation of the behavioral activation for depression scale (BADS) in a community sample with elevated depressive symptoms. Journal of Psychopathology and Behavioral Assessment, 31, 36-42.

  • HAMILTON M. The assessment of anxiety states by rating. Br J Med Psychol. 1959;32(1):50-5. doi: 10.1111/j.2044-8341.1959.tb00467.x. No abstract available.

    PubMed 13638508

  • HAMILTON M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960 Feb;23(1):56-62. doi: 10.1136/jnnp.23.1.56. No abstract available.

    PubMed 14399272

  • American Psychiatric Association. (2000). Diagnostic and statistical manual of mental disorders, (4th ed., text revision). Washington, DC: American Psychiatric Association.

  • McLaughlin NC, Didie ER, Machado AG, Haber SN, Eskandar EN, Greenberg BD. Improvements in anorexia symptoms after deep brain stimulation for intractable obsessive-compulsive disorder. Biol Psychiatry. 2013 May 1;73(9):e29-31. doi: 10.1016/j.biopsych.2012.09.015. Epub 2012 Nov 3. No abstract available.

    PubMed 23128051

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Active DBS in people with Obsessive-Compulsive Disorder, run by Butler Hospital at 9 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 12 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Scale (YBOCS Severity Ratings) (time frame: YBOCS total score observed means at month-12). The study lists 3 primary outcomes in all. 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 NCT00640133, which also lists 9 linked publications.

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 29 Jul 2024.

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