Treatment Resistant Depressive DisorderNCT03667872
Efficacy and Safety of DBS in Patients With Treatment-Resistant Depression
A study testing Bilateral implantation of DBS system to Habeluna in people with Treatment Resistant Depressive Disorder, run by Beijing Pins Medical Co., Ltd at 1 site in China.
Trial summary
The habenula (Hb) is an ancient structure, located at the center of the dorsal diencephalic conduction system, a pathway involved in linking forebrain to midbrain regions. An increasing number of studies indicated that the lateral habeluna (LHb) is overactivity during depressive behaviors in rats, where it could drive… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Treatment Resistant Depressive Disorder
- What is being tested?
- Bilateral implantation of DBS system to Habeluna
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2019to 18 Jun 2022
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 years old;
- DSM-IV diagnosis of Major depression disorder of psychiatrists;
- More than 3 year's history of depression and failure to respond to a minimum of three different antidepressant treatments;
- Failure or intolerance or unwilling of an adequate course of electroconvulsive therapy (ECT) during any episode;
- HAMD-17≥20;
- GAF≤50；
- Capacity to provide informed consent (understanding of the study purpose and methods);
Who cannot join
- Obvious medical and psychiatric comorbidities;
- Alcohol or substance abuse/dependence within 12 months;
- Antisocial personality disorder, dementia, current tic disorder;
- Subject has a history of 2 or more suicide attempts < 12 months prior to the screening testing;
- Pregnancy and/or lactation;
- There are contraindications for DBS surgery and chronic stimulation.
Trial locations and contacts
1 site in 1 country.
China1 site
Habenula DBS
Shenzhen, Shenzhen
Xiaodong Cai, 0755-83366388
Yingli Zhang, 0755-25533524
About this study
Official title: Efficacy and Safety of MRI Compatible and Long-term LFP Recordable Deep Brain Stimulation in Patients With Treatment-Resistant Depression
The habenula (Hb) is an ancient structure, located at the center of the dorsal diencephalic conduction system, a pathway involved in linking forebrain to midbrain regions. An increasing number of studies indicated that the lateral habeluna (LHb) is overactivity during depressive behaviors in rats, where it could drive the changes in midbrain monoamine neurotransmitter linked to depression. However, the efficiency and mechanism of deep brain stimulation (DBS) of the LHb and/or its major afferent bundle (i.e., stria medullaris thalami) could treat treatment-resistant major depression (TRD) is still unclear. This research will investigate the effectiveness and mechanism of bilateral MRI Compatible and Long-term LFP Recordable DBS to habenula and/or its major afferent bundle for treatment TRD patients.
- Conditions
- Treatment Resistant Depressive Disorder
- Being tested
- Bilateral implantation of DBS system to Habeluna
- Keywords
- Deep Brain Stimulation, Habenula, Functional magnetic resonance imaging
- Medical subject headings
- Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral implantation of DBS system to HabelunaProcedure or surgery
Bilateral implantation of MRI compatible and LFP recordable DBS system to Habeluna
| Study group | Role | What they receive |
|---|---|---|
| Device | Experimental | MRI compatible and LFP recordable implantable stimulator Receives: Procedure: Bilateral implantation of DBS system to Habeluna |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Hamilton Anxiety Scale
Change in the Hamilton Anxiety Scale after the DBS on
Measured: Baseline（preoperative）,3 months, 6 months, 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start15 Jan 2019 (estimated)
- Primary completion18 Jun 2020 (estimated)
- Study completion18 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment Resistant Depressive DisorderStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Pins Medical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03667872
- Sponsor's protocol ID
- PINS-029
- Status last verified
- Dec 2018
- First submitted
- 10 Sep 2018
- Last updated
- 27 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of MRI Compatible and Long-term LFP Recordable Deep Brain Stimulation in Patients With Treatment-Resistant Depression
- ClinicalTrials.gov ID
- NCT03667872
- Acronym / sponsor ID
- PINS-029
- Conditions
- Treatment Resistant Depressive Disorder
- Keywords
- Deep Brain Stimulation, Habenula, Functional magnetic resonance imaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Beijing Pins Medical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2019 (estimated)
- Primary completion
- 18 Jun 2020 (estimated)
- Study completion
- 18 Jun 2022 (estimated)
- First posted
- 12 Sep 2018 (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 habenula (Hb) is an ancient structure, located at the center of the dorsal diencephalic conduction system, a pathway involved in linking forebrain to midbrain regions. An increasing number of studies indicated that the lateral habeluna (LHb) is overactivity during depressive behaviors in rats, where it could drive the changes in midbrain monoamine neurotransmitter linked to depression. However, the efficiency and mechanism of deep brain stimulation (DBS) of the LHb and/or its major afferent bundle (i.e., stria medullaris thalami) could treat treatment-resistant major depression (TRD) is still unclear. This research will investigate the effectiveness and mechanism of bilateral MRI Compatible and Long-term LFP Recordable DBS to habenula and/or its major afferent bundle for treatment TRD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device | Experimental | Procedure: Bilateral implantation of DBS system to HabelunaMRI compatible and LFP recordable implantable stimulator |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18-70 years old;
- DSM-IV diagnosis of Major depression disorder of psychiatrists;
- More than 3 year's history of depression and failure to respond to a minimum of three different antidepressant treatments;
- Failure or intolerance or unwilling of an adequate course of electroconvulsive therapy (ECT) during any episode;
- HAMD-17≥20;
Key exclusion criteria (6 listed)
- Obvious medical and psychiatric comorbidities;
- Alcohol or substance abuse/dependence within 12 months;
- Antisocial personality disorder, dementia, current tic disorder;
- Subject has a history of 2 or more suicide attempts < 12 months prior to the screening testing;
- Pregnancy and/or lactation;
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 |
|---|---|---|
| Bilateral implantation of DBS system to HabelunaBilateral implantation of MRI compatible and LFP recordable DBS system to Habeluna | Procedure or surgery | Device |
Primary outcome
Change in the Hamilton Anxiety Scale
Time frame: Baseline（preoperative）,3 months, 6 months, 12months
Change in the Hamilton Anxiety Scale after the DBS on
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral implantation of DBS system to Habeluna in people with Treatment Resistant Depressive Disorder, run by Beijing Pins Medical Co., Ltd at 1 site in China.
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 6 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 27 Dec 2018. 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 China. 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.
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 Zhiyan Wang (010-60736388, wzyann@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Hamilton Anxiety Scale (time frame: Baseline（preoperative）,3 months, 6 months, 12months). 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 27 Dec 2018.