Depressive Disorder, MajorNCT05716555
Deep Brain Stimulation for Treatment Resistant Depression
A study testing Deep brain stimulation in people with Depressive Disorder, Major, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This study will investigate the safety and efficacy of deep brain stimulation (DBS) in lateral habenula (LH) for patients with treatment-resistant depression. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- Deep brain stimulation
- Type of treatment
- Medical device
- How many people
- 2 participants
- Where
- 1 siteChina
- Study dates
- 14 Mar 2021to 13 Mar 2024
- 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, regardless of gender;
- Diagnostic And Statistical Manual Of Mental Disorders 5th Ed (DSM-V), for Psychiatrists' Examination of Severe Depressive Disorders;
- Same diagnostic conclusions based on DSM-V made by two independent psychiatrists;
- A minimum of 24 months of depressive history, over 2 or more adequate antidepressant trials with Hamilton Depression Rating Scale (HAMD) reduction rate ≤20% (including MECT) ;
- HAMD-17 scores ⩾ 20 at screening;
- Functional General Assessment Table (GAF) rating ≤50;
- Able to comply with the operational and administrative requirements of participation in the study, and able to give written informed consent.
Who cannot join
- Patients with severe or unstable mental, liver, kidney, endocrine, hematological diseases, or those with psychotic co-morbidities, including personality disorders;
- History of substance abuse in the past 12 months; history of epilepsy, or febrile seizure in childhood;
- Patients who have attempted suicide within the past 6 months, or have had a secondary suicide attempt within the past 2 years;
- Women who are breastfeeding, pregnant, or intend to be pregnant during the clinical study;
- Any surgical contraindications to undergoing deep brain stimulation (DBS);
- Patients who cannot give full informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang University School of Medicine Second Affiliated Hospital
Hangzhou, Zhejiang, 310009
Hemmings Wu, MD, PhD, +86-571-87784716, hemmings@zju.edu.cn
About this study
Official title: Safety and Efficacy of Deep Brain Stimulation for Treatment Resistant Depression
This study will investigate the safety and efficacy of deep brain stimulation (DBS) in lateral habenula (LH) for patients with treatment-resistant depression.
- Conditions
- Depressive Disorder, Major
- Being tested
- Deep brain stimulation
- Keywords
- deep brain stimulation, lateral habenula
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep brain stimulationDevice
Electrical stimulation of lateral habenula
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale
Change in Hamilton Depression Rating Scale score from baseline to 52 weeks after surgery
Measured: 52 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start14 Mar 2021
- Primary completion13 Mar 2023 (estimated)
- Study completion13 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, MajorStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hemmings Wu, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05716555
- Sponsor's protocol ID
- IR2021001074
- Status last verified
- Feb 2023
- First submitted
- 19 Dec 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Deep Brain Stimulation for Treatment Resistant Depression
- ClinicalTrials.gov ID
- NCT05716555
- Acronym / sponsor ID
- IR2021001074
- Conditions
- Depressive Disorder, Major
- Keywords
- deep brain stimulation, lateral habenula
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 14 Mar 2021 (actual)
- Primary completion
- 13 Mar 2023 (estimated)
- Study completion
- 13 Mar 2024 (estimated)
- First posted
- 8 Feb 2023 (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.
This study will investigate the safety and efficacy of deep brain stimulation (DBS) in lateral habenula (LH) for patients with treatment-resistant depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
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, regardless of gender;
- Diagnostic And Statistical Manual Of Mental Disorders 5th Ed (DSM-V), for Psychiatrists' Examination of Severe Depressive Disorders;
- Same diagnostic conclusions based on DSM-V made by two independent psychiatrists;
- A minimum of 24 months of depressive history, over 2 or more adequate antidepressant trials with Hamilton Depression Rating Scale (HAMD) reduction rate ≤20% (including MECT) ;
- HAMD-17 scores ⩾ 20 at screening;
Key exclusion criteria (6 listed)
- Patients with severe or unstable mental, liver, kidney, endocrine, hematological diseases, or those with psychotic co-morbidities, including personality disorders;
- History of substance abuse in the past 12 months; history of epilepsy, or febrile seizure in childhood;
- Patients who have attempted suicide within the past 6 months, or have had a secondary suicide attempt within the past 2 years;
- Women who are breastfeeding, pregnant, or intend to be pregnant during the clinical study;
- Any surgical contraindications to undergoing deep brain stimulation (DBS);
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 stimulationElectrical stimulation of lateral habenula | Device | – |
Primary outcome
Hamilton Depression Rating Scale
Time frame: 52 weeks after surgery
Change in Hamilton Depression Rating Scale score from baseline to 52 weeks after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: Yes
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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 Deep brain stimulation in people with Depressive Disorder, Major, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 8 Feb 2023. 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 Hemmings Wu, MD, PhD (+86-571-87784716, hemmings@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depression Rating Scale (time frame: 52 weeks after surgery). 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 8 Feb 2023.