Obsessive-Compulsive DisorderNCT06628752
Deep Brain Stimulation for Obsessive-compulsive Disorder
A study testing Deep brain stimulation in people with Obsessive-Compulsive Disorder, run by Umeå University at 1 site in Sweden.
Trial summary
The goal of this clinical trial is to evaluate the treatment method of deep brain stimulation (DBS) in patients diagnosed with severe and treatment-resistant obsessive-compulsive disorder (OCD). DBS will be administered into the brain area of the bed nucleus of stria terminalis (BNST). 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?
- Deep brain stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteSweden
- Study dates
- 11 Sep 2018to 31 Dec 2030
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- OCD diagnosed according to the criteria in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV).
- The patients should have received at least 16 sessions of cognitive behavioral therapy, tried three different serotonergic antidepressants in adequate doses for three months, and one serotonergic antidepressant in combination with a neuroleptic drug.
- Severe OCD symptoms: YBOCS ≥ 25 points.
- Substantial incapacity because of his/her symptoms.
- Duration of symptoms: 5 years minimum.
- Understand the consequences of participation in the study and give informed written consent.
Who cannot join
- Not being able to understand the consequences of the treatment.
- Diagnosed with intellectual disability according to DSM-IV.
- Not meeting the requirements for the neurosurgery procedure.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Umeå University
Umeå, Västerbotten County, 90187
Viktoria Johansson, PhD, +46-90-786 50 00, viktoria.johansson@umu.se
Matilda Naesstrom, PhD, +46-90-786 50 00, matilda.naesstrom@umu.se
About this study
Official title: Deep Brain Stimulation for the Treatment of Severe Obsessive-compulsive Disorder
The goal of this clinical trial is to evaluate the treatment method of deep brain stimulation (DBS) in patients diagnosed with severe and treatment-resistant obsessive-compulsive disorder (OCD). DBS will be administered into the brain area of the bed nucleus of stria terminalis (BNST).
The main research questions are:
Read more
- Does active DBS in BNST reduce OCD symptoms (primary outcome)?
- Does active DBS in BNST reduce anxiety or depressive symptoms and improve the level of daily function?
The participants will be randomized to active or sham DBS in the BNST for six months and we will measure the outcomes before DBS surgery, and six months post-surgery. After the randomization phase, the participants will enter an open-label phase and receive continuous DBS in BNST. Yearly follow-ups will be conducted. The outcomes will be measured through interviews using validated psychometric scales.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Deep brain stimulation
- Keywords
- Obsessive-Compulsive Disorder, Deep Brain Stimulation, Randomized Controlled Trial
- 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.
Deep brain stimulationDevice
Stimulation through a device implanted bilaterally into deep brain structures.
| Study group | Role | What they receive |
|---|---|---|
| Active stimulation | Active comparator | Deep brain stimulation - active stimulation Receives: Device: Deep brain stimulation |
| Sham stimulation | Sham comparator | Deep brain stimulation - no stimulation Receives: Device: Deep brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale-Brown Obsessive Compulsive Scale, Y-BOCS
Validated psychometric scale that measures symptoms of OCD.
Measured: From enrollment to the end of treatment after 6 months.
Secondary outcomes (5)
Hamilton Anxiety Scale, HAS
Validated psychometric scale that measures symptoms of anxiety.
Measured: From enrollment to the end of treatment after 6 months.
Hamilton Depression scale, HAMD
Validated psychometric scale that measures symptoms of depression.
Measured: From enrollment to the end of treatment after 6 months.
Montgomery Asberg Depression Rating Scale, MADRS
Validated psychometric scale that measures symptoms of depression.
Measured: From enrollment to the end of treatment after 6 months.
Global Assessment of Functioning, GAF
Scale that measures level of functioning.
Measured: From enrollment to the end of treatment after 6 months.
Clinical Global Impression rating scale, CGI
Scale that measures symptom improvement.
Measured: From enrollment to the end of treatment after 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start11 Sep 2018
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (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 Umeå 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Region Västerbotten
- Responsible party
- Sponsor
- Investigators
- Patric Blomstedt, Professor, Study chair, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06628752
- Sponsor's protocol ID
- 19-2018
- Status last verified
- Oct 2024
- First submitted
- 3 Oct 2024
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not share IPD until the study is finished and results are published.
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Brain Stimulation for the Treatment of Severe Obsessive-compulsive Disorder
- ClinicalTrials.gov ID
- NCT06628752
- Acronym / sponsor ID
- 19-2018
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Obsessive-Compulsive Disorder, Deep Brain Stimulation, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Region Västerbotten
- Study start
- 11 Sep 2018 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 8 Oct 2024 (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 goal of this clinical trial is to evaluate the treatment method of deep brain stimulation (DBS) in patients diagnosed with severe and treatment-resistant obsessive-compulsive disorder (OCD). DBS will be administered into the brain area of the bed nucleus of stria terminalis (BNST).
The main research questions are:
- Does active DBS in BNST reduce OCD symptoms (primary outcome)?
- Does active DBS in BNST reduce anxiety or depressive symptoms and improve the level of daily function?
The participants will be randomized to active or sham DBS in the BNST for six months and we will measure the outcomes before DBS surgery, and six months post-surgery. After the randomization phase, the participants will enter an open-label phase and receive continuous DBS in BNST. Yearly follow-ups will be conducted. The outcomes will be measured through interviews using validated psychometric scales.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Active stimulation | Active comparator | Device: Deep brain stimulationDeep brain stimulation - active stimulation |
| Sham stimulation | Sham comparator | Device: Deep brain stimulationDeep brain stimulation - no stimulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- OCD diagnosed according to the criteria in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV).
- The patients should have received at least 16 sessions of cognitive behavioral therapy, tried three different serotonergic antidepressants in adequate doses for three months, and one serotonergic antidepressant in combination with a neuroleptic drug.
- Severe OCD symptoms: YBOCS ≥ 25 points.
- Substantial incapacity because of his/her symptoms.
- Duration of symptoms: 5 years minimum.
Key exclusion criteria (3 listed)
- Not being able to understand the consequences of the treatment.
- Diagnosed with intellectual disability according to DSM-IV.
- Not meeting the requirements for the neurosurgery procedure.
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 |
|---|---|---|
| Deep brain stimulationStimulation through a device implanted bilaterally into deep brain structures. | Device | Active stimulation, Sham stimulation |
Primary outcome
Yale-Brown Obsessive Compulsive Scale, Y-BOCS
Time frame: From enrollment to the end of treatment after 6 months.
Validated psychometric scale that measures symptoms of OCD.
5 secondary outcomes
Hamilton Anxiety Scale, HAS
Time frame: From enrollment to the end of treatment after 6 months.
Hamilton Depression scale, HAMD
Time frame: From enrollment to the end of treatment after 6 months.
Montgomery Asberg Depression Rating Scale, MADRS
Time frame: From enrollment to the end of treatment after 6 months.
Global Assessment of Functioning, GAF
Time frame: From enrollment to the end of treatment after 6 months.
Clinical Global Impression rating scale, CGI
Time frame: From enrollment to the end of treatment after 6 months.
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 17 Oct 2024.
- Individual participant dataSharing planned: No. We will not share IPD until the study is finished and results are published.
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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.
Patric Blomstedt, Professor study chair
Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep brain stimulation in people with Obsessive-Compulsive Disorder, run by Umeå University at 1 site in Sweden.
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 6 inclusion and 3 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 17 Oct 2024. 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 Sweden. 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.
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 Viktoria Johansson, PhD (+46-90-786 50 00, viktoria.johansson@umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Yale-Brown Obsessive Compulsive Scale, Y-BOCS (time frame: From enrollment to the end of treatment after 6 months.). 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 17 Oct 2024.