Obsessive Compulsive DisorderNCT02601677
Deep Brain Stimulation of NAc/ALIC to Prevent Treatment-Refractory Obsessive Compulsive Disorder
A study testing Deep brain stimulation and Fluoxetine in people with Obsessive Compulsive Disorder, run by Tang-Du Hospital.
Trial summary
Nucleus accumbens/anterior limb of internal capsule play important roles in the process of treatment-refractory obsessive compulsive disorder, deep brain stimulation of nucleus accumbens/anterior limb of internal capsule will inhibit its activity and thus to effectively prevent the disorder. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obsessive Compulsive Disorder
- What is being tested?
- Deep brain stimulation and Fluoxetine
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Nov 2018
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Diagnosis of OCD following the diagnostic and statistical manual of mental disorders-fourth edition (DSM-IV) criteria for OCD;
- Duration of illness: min. 5 year;
- 18 years old <Age <60 years old;
- Severe form of OCD, as evidenced by: a score≥25 on the Y-BOCS, a score > 4 on the CGI scale, a score≤40 on the GAF ("global assessment of functioning).
- All patients were lack of response to drug therapy after adequate administration (defined as more than 12 weeks at the maximum tolerated dose) of at least four different medications, lack of response to CBT (Cognitive Behaviour Therapy)over the course of 1 year of therapy or after 20 sessions.
- Normal cognitive status and ability to understand and comply with instructions for multiple therapies.
- Good overall health.
Who cannot join
- Present or past history of psychotic symptoms.
- Severe personality disorders;
- Any clinically significant neurological disorder or medical illnesses affect ;
- brain function, other than motor tics or Gilles de la Tourette syndrome;
- Patient currently treated with anticoagulant or antiplatelet drug;
- Patient with contraindication for surgery or anesthesia;
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- Inability to undergo awaked operation;
- Infection, coagulopathy, significant cardiac or other medical risk factors for surgery;
- Patient with contraindication for MRI scanning (cardiac pacemaker, pregnancy, metal in body, severe claustrophobia), abnormal brain MRI or serious inter current disease
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Deep Brain Stimulation of Nucleus Accumbens/Anterior Limb of Internal Capsule to Prevent Treatment-Refractory Obsessive Compulsive Disorder
Nucleus accumbens/anterior limb of internal capsule play important roles in the process of treatment-refractory obsessive compulsive disorder, deep brain stimulation of nucleus accumbens/anterior limb of internal capsule will inhibit its activity and thus to effectively prevent the disorder.
Read the detailed description
Obsessive-compulsive disorder (OCD) is characterized by obsessions (persistent thoughts) and compulsions (repetitive ritualistic behaviour). Core symptoms of OCD cause remarkable distress and often perceived as inappropriate. The prevalence of OCD in the general population is estimated between 1% and 3%. It is a psychiatric illness that can lead to chronic functional impairment. Treatment options for OCD include cognitive behavioural therapy (CBT) and/or pharmacotherapy. Even when the best treatment options are used, approximately 10% of these patients remain severely affected and are considered therapy-refractory resulting in marked suffering and impairment in self-care, work and social life. More recently, deep brain stimulation (DBS) has been investigated as a therapy for refractory OCD, and the procedure was granted a limited humanitarian device exemption by the FDA in 2009. For these patients, deep brain stimulation (DBS), a neurosurgical treatment that involves stereotactic implantation of electrodes in specific deep-seated brain regions, has emerged as a new treatment option.
- Conditions
- Obsessive Compulsive Disorder
- Being tested
- Deep brain stimulation, Fluoxetine
- Keywords
- Obsessive Compulsive Disorder, Deep Brain Stimulation, 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
Deep brain stimulation of bilateral Nucleus accumbens/Anterior Limb of Internal Capsule
FluoxetineDrug
Fluoxetine is one of selective serotonin reuptake inhibitors(SSRIs).
| Study group | Role | What they receive |
|---|---|---|
| Deep Brain Stimulation | Experimental | Continuous deep brain stimulation of bilateral nucleus accumbens Receives: Procedure: Deep brain stimulation |
| Standard Control | Active comparator | Fluoxetine Receives: Drug: Fluoxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Measured: 6 month
Secondary outcomes (8)
Clinical Global Impression (CGI)
Measured: 6 month
Global assessment of functioning (GAF)
Measured: 6 month
The Hamilton Anxiety Scale (HAM-A)
Measured: 6 month
The Hamilton Rating Scale for Depression (HAM-D)
Measured: 6 month
Sheehan Disability Scale (SDS)
Measured: 6 month
Event related potentials(ERPs)
Measured: Baseline,3 month,6 month and 12 month
local field potential(LFP)
Measured: in surgery,7 days after surgery
Change in two static positron emission tomography(PET) images study
Measured: Baseline and 6month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionNov 2018 (estimated)
- Study completionNov 2018 (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 Tang-Du HospitalThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guodong Gao, Tang-Du Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02601677
- Sponsor's protocol ID
- OCD-DBS
- Status last verified
- Nov 2015
- First submitted
- 8 Nov 2015
- Last updated
- 10 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Brain Stimulation of Nucleus Accumbens/Anterior Limb of Internal Capsule to Prevent Treatment-Refractory Obsessive Compulsive Disorder
- ClinicalTrials.gov ID
- NCT02601677
- Acronym / sponsor ID
- OCD-DBS
- Conditions
- Obsessive Compulsive Disorder
- Keywords
- Obsessive Compulsive Disorder, Deep Brain Stimulation, Nucleus accumbens
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 10 Nov 2015 (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.
Nucleus accumbens/anterior limb of internal capsule play important roles in the process of treatment-refractory obsessive compulsive disorder, deep brain stimulation of nucleus accumbens/anterior limb of internal capsule will inhibit its activity and thus to effectively prevent the disorder.
Detailed description
Obsessive-compulsive disorder (OCD) is characterized by obsessions (persistent thoughts) and compulsions (repetitive ritualistic behaviour). Core symptoms of OCD cause remarkable distress and often perceived as inappropriate. The prevalence of OCD in the general population is estimated between 1% and 3%. It is a psychiatric illness that can lead to chronic functional impairment. Treatment options for OCD include cognitive behavioural therapy (CBT) and/or pharmacotherapy. Even when the best treatment options are used, approximately 10% of these patients remain severely affected and are considered therapy-refractory resulting in marked suffering and impairment in self-care, work and social life. More recently, deep brain stimulation (DBS) has been investigated as a therapy for refractory OCD, and the procedure was granted a limited humanitarian device exemption by the FDA in 2009. For these patients, deep brain stimulation (DBS), a neurosurgical treatment that involves stereotactic implantation of electrodes in specific deep-seated brain regions, has emerged as a new treatment option.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deep Brain Stimulation | Experimental | Procedure: Deep brain stimulationContinuous deep brain stimulation of bilateral nucleus accumbens |
| Standard Control | Active comparator | Drug: FluoxetineFluoxetine |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Diagnosis of OCD following the diagnostic and statistical manual of mental disorders-fourth edition (DSM-IV) criteria for OCD;
- Duration of illness: min. 5 year;
- 18 years old <Age <60 years old;
- Severe form of OCD, as evidenced by: a score≥25 on the Y-BOCS, a score > 4 on the CGI scale, a score≤40 on the GAF ("global assessment of functioning).
- All patients were lack of response to drug therapy after adequate administration (defined as more than 12 weeks at the maximum tolerated dose) of at least four different medications, lack of response to CBT (Cognitive Behaviour Therapy)over the course of 1 year of therapy or after 20 sessions.
Key exclusion criteria (9 listed)
- Present or past history of psychotic symptoms.
- Severe personality disorders;
- Any clinically significant neurological disorder or medical illnesses affect ;
- brain function, other than motor tics or Gilles de la Tourette syndrome;
- Patient currently treated with anticoagulant or antiplatelet drug;
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 stimulationDeep brain stimulation of bilateral Nucleus accumbens/Anterior Limb of Internal Capsule | Procedure or surgery | Deep Brain Stimulation |
| FluoxetineFluoxetine is one of selective serotonin reuptake inhibitors(SSRIs). | Drug | Standard Control |
Primary outcome
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Time frame: 6 month
8 secondary outcomes
Clinical Global Impression (CGI)
Time frame: 6 month
Global assessment of functioning (GAF)
Time frame: 6 month
The Hamilton Anxiety Scale (HAM-A)
Time frame: 6 month
The Hamilton Rating Scale for Depression (HAM-D)
Time frame: 6 month
Sheehan Disability Scale (SDS)
Time frame: 6 month
Event related potentials(ERPs)
Time frame: Baseline,3 month,6 month and 12 month
local field potential(LFP)
Time frame: in surgery,7 days after surgery
Change in two static positron emission tomography(PET) images study
Time frame: Baseline and 6month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2015.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Deep brain stimulation and Fluoxetine in people with Obsessive Compulsive Disorder, run by Tang-Du Hospital.
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 7 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: status not confirmed, as of the sponsor's last update on 10 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guo-dong Gao, M.D. (+86 29 84777435, gguodong@fmmu.edu.cn), 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: 6 month). 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 10 Nov 2015.