Obsessive-Compulsive DisorderPhase 3PRESTOC2NCT01807403
Comparison of DBS Targets in Obsessive-compulsive Disorder
A Phase 3 study testing Deep brain stimulation in people with Obsessive-Compulsive Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Deep brain stimulation (DBS) has been proposed for severe and resistant obsessive-compulsive disorder. This electrical stimulation has been tested on, and shown to be effective at, different targets (subthalamic nucleus, caudate nucleus \& nucleus accumbens). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Deep brain stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2010to Feb 2016
- Phase
- Phase 3
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 - 60
- OCD according to DSM IV, at least 5 years since diagnosis
- Severe OCD responsible for a clinically significant and objective alteration of psychosocial functioning and suffering: YBOCS score>25, CGI score >= 4 and EGF score <= 40
- Resistance of OCD to at least 3 antidepressants from the serotonin reuptake inhibitors category, including clomipramine, given for at least 12 weeks with doses of at least 80mg/d for fluoxetine, 300mg/d for fluvoxamine, 200mg/d for sertraline, 60mg/d for paroxetine and citalopram, 250mg/d for clomipramine). Plus resistance to each of these 3 antidepressant associated first to risperidone or pimozide for a month then to Lithium carbonate, clonazepam, buspirone or pindolol for a month
- Resistance to at least 2 behavioural and cognitive therapies conducted by as many different specialists, following validated protocols (e.g. exposition and prevention of response)
- Oral and written knowledge of French
- Social security coverage
- Written consent of the patient after clear description of the study
Who cannot join
- cognitive alteration with PM38 score < IQ85
- Other axis 1 disorder according to DSM IV, excepted, global anxiety disorder, social phobia, nicotine dependance, and antecedent of major depressive episodes
- suicidal risk >=2 on item 10 of MADRS (Montgomery Asberg Depression Rating Scale)
- Personality disorder (axis 2 of DSM IV assessed using the SCID II)
- Contra indication to MRI, abnormal brain MRI, other severe intercurrent disease
- Fertile woman without adequate contraception
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- Pregnancy
- Forced psychiatric hospitalisation
- Any kind of legal protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Efficacy of Subthalamic Nucleus, Caudate Nucleus and Nucleus Accumbens Electric Stimulation in Severe and Resistant Obsessive-compulsive Disorder.
Deep brain stimulation (DBS) has been proposed for severe and resistant obsessive-compulsive disorder. This electrical stimulation has been tested on, and shown to be effective at, different targets (subthalamic nucleus, caudate nucleus \& nucleus accumbens). However, the efficacies of each target have never been compared directly.
This protocol aims to do so, with the hypothesis that subthalamic (STN) stimulation will be more efficacious.
Read the detailed description
Deep brain stimulation has been proposed for severe and resistant obsessive-compulsive disorder (OCD). This electrical stimulation has been tested on, and shown to be effective at, different targets (subthalamic nucleus, caudate nucleus \& nucleus accumbens). However, the efficacies of each target have never been compared directly.
Therefore, bilateral subthalamic and caudate electrodes will be implanted in severe OCD patients. Efficacy of stimulation at the different targets will be assessed using a double-blind randomised crossover design.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Deep brain stimulation
- Keywords
- Obsessive-Compulsive Disorder, Deep brain stimulation, Subthalamic nucleus, Caudate nucleus, Nucleus accumbens
- 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 stimulationProcedure or surgery
Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.
| Study group | Role | What they receive |
|---|---|---|
| Deep brain stimulation of subthalamic nucleus | Experimental | Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.Stimulation of subthalamic nucleus Receives: Procedure: Deep brain stimulation |
| Deep brain stimulation of caudate nucleus | Experimental | Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker. Caudate nucleus stimulation Receives: Procedure: Deep brain stimulation |
| Deep brain stimulation of nucleus accumbens | Experimental | Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.Nucleus accumbens stimulation. Receives: Procedure: Deep brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of symptoms after each phase
Severity as measured by the Yale-Brown Obsession and Compulsion scale
Measured: 3 months
Secondary outcomes (4)
Severity of symptoms after each phase
Severity as measured by the Yale-Brown Obsession and Compulsion scale
Measured: month 0
Severity of symptoms after each phase
Severity as measured by the Yale-Brown Obsession and Compulsion scale
Measured: 6 months
Severity of symptoms after each phase
Severity as measured by the Yale-Brown Obsession and Compulsion scale
Measured: 10 months
Severity of symptoms after each phase
Severity as measured by the Yale-Brown Obsession and Compulsion scale
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2013 (estimated)
- Study startOct 2010
- Primary completionFeb 2016
- Study completionFeb 2016
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 Assistance Publique - Hôpitaux de ParisThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luc Mallet, MD, PhD, Principal investigator, Assitance Publique - Hopitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01807403
- Sponsor's protocol ID
- P081203
- Acronym
- PRESTOC2
- Status last verified
- Apr 2015
- First submitted
- 25 Jan 2013
- Last updated
- 18 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Subthalamic Nucleus, Caudate Nucleus and Nucleus Accumbens Electric Stimulation in Severe and Resistant Obsessive-compulsive Disorder.
- ClinicalTrials.gov ID
- NCT01807403
- Acronym / sponsor ID
- PRESTOC2 / P081203
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Obsessive-Compulsive Disorder, Deep brain stimulation, Subthalamic nucleus, Caudate nucleus, Nucleus accumbens
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 8 Mar 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.
Deep brain stimulation (DBS) has been proposed for severe and resistant obsessive-compulsive disorder. This electrical stimulation has been tested on, and shown to be effective at, different targets (subthalamic nucleus, caudate nucleus \& nucleus accumbens). However, the efficacies of each target have never been compared directly.
This protocol aims to do so, with the hypothesis that subthalamic (STN) stimulation will be more efficacious.
Detailed description
Deep brain stimulation has been proposed for severe and resistant obsessive-compulsive disorder (OCD). This electrical stimulation has been tested on, and shown to be effective at, different targets (subthalamic nucleus, caudate nucleus \& nucleus accumbens). However, the efficacies of each target have never been compared directly.
Therefore, bilateral subthalamic and caudate electrodes will be implanted in severe OCD patients. Efficacy of stimulation at the different targets will be assessed using a double-blind randomised crossover design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Deep brain stimulation of subthalamic nucleus | Experimental | Procedure: Deep brain stimulationPose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.Stimulation of subthalamic nucleus |
| Deep brain stimulation of caudate nucleus | Experimental | Procedure: Deep brain stimulationPose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker. Caudate nucleus stimulation |
| Deep brain stimulation of nucleus accumbens | Experimental | Procedure: Deep brain stimulationPose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.Nucleus accumbens stimulation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age 18 - 60
- OCD according to DSM IV, at least 5 years since diagnosis
- Severe OCD responsible for a clinically significant and objective alteration of psychosocial functioning and suffering: YBOCS score>25, CGI score >= 4 and EGF score <= 40
- Resistance of OCD to at least 3 antidepressants from the serotonin reuptake inhibitors category, including clomipramine, given for at least 12 weeks with doses of at least 80mg/d for fluoxetine, 300mg/d for fluvoxamine, 200mg/d for sertraline, 60mg/d for paroxetine and citalopram, 250mg/d for clomipramine). Plus resistance to each of these 3 antidepressant associated first to risperidone or pimozide for a month then to Lithium carbonate, clonazepam, buspirone or pindolol for a month
- Resistance to at least 2 behavioural and cognitive therapies conducted by as many different specialists, following validated protocols (e.g. exposition and prevention of response)
Key exclusion criteria (9 listed)
- cognitive alteration with PM38 score < IQ85
- Other axis 1 disorder according to DSM IV, excepted, global anxiety disorder, social phobia, nicotine dependance, and antecedent of major depressive episodes
- suicidal risk >=2 on item 10 of MADRS (Montgomery Asberg Depression Rating Scale)
- Personality disorder (axis 2 of DSM IV assessed using the SCID II)
- Contra indication to MRI, abnormal brain MRI, other severe intercurrent disease
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 stimulationPose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker. | Procedure or surgery | Deep brain stimulation of caudate nucleus, Deep brain stimulation of nucleus accumbens, Deep brain stimulation of subthalamic nucleus |
Primary outcome
Severity of symptoms after each phase
Time frame: 3 months
Severity as measured by the Yale-Brown Obsession and Compulsion scale
4 secondary outcomes
Severity of symptoms after each phase
Time frame: month 0
Severity of symptoms after each phase
Time frame: 6 months
Severity of symptoms after each phase
Time frame: 10 months
Severity of symptoms after each phase
Time frame: 14 months
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 18 May 2016.
- 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. This study is not recruiting at the moment.
Luc Mallet, MD, PhD principal investigator
Assitance Publique - Hopitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Deep brain stimulation in people with Obsessive-Compulsive Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 8 inclusion and 9 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 18 May 2016. 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 France. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Severity of symptoms after each phase (time frame: 3 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 18 May 2016.