- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03360942
Long Term Follow-up of Deep Brain Stimulation for Treatment-Resistant Depression
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The U.S. lifetime prevalence of major depressive disorder (MDD) is 17%. A number of treatments are available for depression including medications, psychotherapy and various somatic treatments. Unfortunately, up to two-thirds of patients remain symptomatic following first-line treatment and a third fail to achieve remission (defined as full resolution of depressive symptoms) after four established treatments; approximately 10%-20% of depressed patients may show virtually no improvement despite multiple, often aggressive treatments. Thus, a conservative estimate places the U.S. prevalence of treatment-resistant depression (TRD) at 1%-3%. TRD has a high risk of suicide, is a major cause of disability and is responsible for doubling of overall health care costs.
For patients with TRD there are limited evidence-based treatment options. Transcranial magnetic stimulation (TMS) may have efficacy for patients that have failed no more than one antidepressant medication 10-12, but response and remission rates are relatively low (under 30% and 20% respectively). Vagus nerve stimulation (VNS) may have efficacy in patients that have failed 4-6 antidepressant treatments but long-term response and remission rates are again low (about 20% and 10% respectively). Electroconvulsive therapy(ECT) can be effective in TRD patients with remission rates of 50%-60%. However, more than 70% of TRD patients will relapse within 6 months following a successful acute treatment course. For patients that have failed ECT, there are no evidence-based treatment options. Therefore, there is great need for novel treatment approaches for TRD.
Prior clinical trials have shown that SCC DBS has the potential to be a valuable treatment option for patients with TRD. Further developing this treatment will involve confirming its effectiveness and identifying ways to optimize its use. In this study the investigators intend to test the safety and efficacy of chronic SCC DBS as a treatment for TRD and compare the safety and efficacy of left-sided versus right-sided stimulation using a double-blind, randomized, cross-over design.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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New Hampshire
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Lebanon, New Hampshire, United States, 03766
- Dartmouth-Hitchcock Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Have received DBS for TRD
- Ability to provide written informed consent
- Willing to comply with all necessary study visits
Exclusion Criteria:
- Significant cerebrovascular risk factors or a previous stroke, documented major head trauma or neurodegenerative disorder.
- Other currently active clinically significant Axis I psychiatric diagnosis including schizophrenia, panic disorder, obsessive-compulsive disorder, generalized anxiety disorder or post-traumatic stress disorder. Patients with severe Axis II personality disorders will also be excluded if the personality disorder is likely to interfere with cooperation and adherence to the study protocol.
- Current psychotic symptoms.
- Evidence of global cognitive impairment.
- Substance abuse or dependence not in full sustained remission (i.e., not active for at least one year).
- Active suicidal ideation with intent; suicide attempt within the last six months; more than three suicide attempts within the last two years.
- Pregnancy or plan to become pregnant during the study period.
- General contraindications for DBS surgery (cardiac pacemaker/defibrillator or other implanted devices).
- Inability or unwillingness to comply with long-term follow-up.
- History of intolerance to neural stimulation of any area of the body.
- Participation in another drug, device or biologics trial within the preceding 30 days.
- Conditions requiring repeated MRI scans.
- Conditions requiring diathermy.
- Conditions requiring anticoagulant medication.
- Terminal illness associated with expected survival of <12 months.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
DBS Long Term Follow Up
5 participants who were in a prior study to receive DBS are enrolled to have their progress and DBS devices monitored for a period of 12 years.
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Deep Brain Stimulator
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physician assessment of current status
Time Frame: Every 12 months
|
During this phase, patients will be evaluated every 12 months by the study psychiatrist (via in-person, phone or video call visit) to assess device functioning, adverse events and current status of depression.
Collectively, this information will be used to evaluate each patient's current status.
No formal instruments will be used to collect these data.
This information will be documented in a note to file.
|
Every 12 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D12131
- 23442 (Other Identifier: Dartmouth Committee for the Protection of Human Subjects)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Treatment Resistant Depression
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Changping LaboratoryBeijing HuiLongGuan HospitalRecruitingTreatment-Resistant DepressionChina
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Central Institute of Mental Health, MannheimCharite University, Berlin, Germany; German Federal Ministry of Education and... and other collaboratorsActive, not recruitingTreatment-resistant DepressionGermany
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Janssen Research & Development, LLCCompletedTreatment-resistant DepressionUnited States, Australia, France, United Kingdom, Belgium, Germany, Taiwan, Spain, Argentina, Mexico, Poland, Bulgaria, Malaysia, South Africa, Turkey, Finland, Korea, Republic of, Brazil, Austria, Sweden, Lithuania
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Janssen Research & Development, LLCCompletedTreatment-resistant DepressionUnited States, France, Belgium, Mexico, Canada, Brazil, Estonia, Hungary, Slovakia
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University of OttawaCanadian Institutes of Health Research (CIHR)Completed
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GH Research Ireland LimitedRecruitingTreatment-resistant DepressionIreland, Czechia
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First Affiliated Hospital of Zhejiang UniversityRecruitingTreatment-resistant DepressionChina
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University Hospital FreiburgBoston Scientific CorporationRecruitingTreatment-resistant DepressionGermany, France
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Janssen Research & Development, LLCCompletedTreatment-resistant DepressionUnited States, Poland, Germany, Spain, Czechia
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Millennium Pharmaceuticals, Inc.WithdrawnTreatment-Resistant Depression
Clinical Trials on SCC DBS
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Paul HoltzheimerCompletedTreatment Resistant Depression | Depressive Disorder, Treatment-Resistant | Depression, BipolarUnited States
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University of ZurichLeiden University Medical CenterActive, not recruitingSquamous Cell CarcinomaNetherlands, Switzerland
-
Public Health Foundation of IndiaUBS Optimus Foundation; The Children's Investment Fund FoundationCompleted
-
Second Affiliated Hospital of Wenzhou Medical UniversityCompletedMagnetic Resonance Imaging ExaminationChina
-
Asociación Mexicana de Salud PrimalNot yet recruitingMother-Child Relations | Breastfeeding, Exclusive | Kangaroo-mother Care
-
RANDEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedSafer Conception Intervention TrialUganda
-
Deep Brain Innovations LLCTerminatedParkinson DiseaseUnited States
-
Chinese PLA General HospitalNot yet recruitingCervical DystoniaChina
-
University Medical Center GroningenUnknown
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Temple UniversityUnknownSedentary Lifestyle | Cigarette SmokingUnited States