Treatment-Resistant DepressionEarly Phase 1NCT02253355
PINS Stimulator System for Patients With Treatment Resistant Depression
A Early Phase 1 study testing Deep Brain Stimulation in people with Treatment-Resistant Depression, run by Beijing Pins Medical Co., Ltd.
Trial summary
Evaluate the effects and safety of Deep Brain Stimulation (DBS) to treat on patients with Treatment-Resistant Depression (TRD) and using functional magnetic resonance imaging (fMRI)to evaluate the influence of acupuncture on patients, which will be afford objective evidence for the mechanism of Acupuncture on… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Treatment-Resistant Depression
- What is being tested?
- Deep Brain Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Dec 2018
- Phase
- Early Phase 1
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is aged ages 20-70 years
- Diagnosed with non-psychotic major depressive disorder, single or recurrent episode by DSM-IV-TR criteria
- First episode onset before age 45
- Current episode > 12 months duration
- In the current episode: Documented resistance (i.e. persistence of the major depressive episode) to a minimum of 4 adequate depression treatments from at least 3 different treatment categories (e.g. SSRI's)
- SNRI's, TCA's, MAO-inhibitors, Mirtazipine, Nefazodone, Trazodone, Bupropion, lithium augmentation, thyroid augmentation, ECT); Adequacy of treatments as defined by a score of at least 3 according to the amended Antidepressant Treatment History Form (ATHF) criteria
- Hamilton Depression Rating Scale (HDRS) of > 20 at 3 separate baseline visits, rated by 2 separate psychiatrists, Baseline 2 and Baseline 3 HDRS scores cannot improve ≥ 25%
Who cannot join
- Patients with hearing impairment
- Failures of important organs and in severe conditions
- Be reluctant or disabled to receive neuropsychological assessments;
- Participate in other clinical trial
- Has a life expectancy of < 1 year
- The investigator and/or enrollment review committee, would preclude participation in the study
Trial locations and contacts
No sites are listed yet.
About this study
Evaluate the effects and safety of Deep Brain Stimulation (DBS) to treat on patients with Treatment-Resistant Depression (TRD) and using functional magnetic resonance imaging (fMRI)to evaluate the influence of acupuncture on patients, which will be afford objective evidence for the mechanism of Acupuncture on depression.
- Conditions
- Treatment-Resistant Depression
- Being tested
- Deep Brain Stimulation
- 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.
Deep Brain StimulationDevice
Also called PINS Stimulator System
| Study group | Role | What they receive |
|---|---|---|
| Deep Brain Stimulation | Experimental | Stimulation is on Receives: Device: Deep Brain Stimulation |
| Placebo | Sham comparator | Stimulation is off Receives: Device: Deep Brain Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the Hamilton Depression Rating Scale-17
Measured: 1, 3, 6 and 12 months of stimulation
Secondary outcomes (1)
The incidence of all adverse events
Measured: 1, 3, 6 and 12 months of stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study startDec 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment-Resistant DepressionStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Pins Medical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Tiantan Hospital
- Responsible party
- Sponsor
- Investigators
- Li Luming, PhD, Study chair, Tsinghua University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02253355
- Sponsor's protocol ID
- PINS-006
- Status last verified
- Aug 2016
- First submitted
- 27 Sep 2014
- Last updated
- 14 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PINS Stimulator System for Patients With Treatment Resistant Depression
- ClinicalTrials.gov ID
- NCT02253355
- Acronym / sponsor ID
- PINS-006
- Conditions
- Treatment-Resistant Depression
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Beijing Pins Medical Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Beijing Tiantan Hospital
- Study start
- Dec 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 1 Oct 2014 (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.
Evaluate the effects and safety of Deep Brain Stimulation (DBS) to treat on patients with Treatment-Resistant Depression (TRD) and using functional magnetic resonance imaging (fMRI)to evaluate the influence of acupuncture on patients, which will be afford objective evidence for the mechanism of Acupuncture on depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deep Brain Stimulation | Experimental | Device: Deep Brain StimulationStimulation is on |
| Placebo | Sham comparator | Device: Deep Brain StimulationStimulation is off |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject is aged ages 20-70 years
- Diagnosed with non-psychotic major depressive disorder, single or recurrent episode by DSM-IV-TR criteria
- First episode onset before age 45
- Current episode > 12 months duration
- In the current episode: Documented resistance (i.e. persistence of the major depressive episode) to a minimum of 4 adequate depression treatments from at least 3 different treatment categories (e.g. SSRI's)
Key exclusion criteria (6 listed)
- Patients with hearing impairment
- Failures of important organs and in severe conditions
- Be reluctant or disabled to receive neuropsychological assessments;
- Participate in other clinical trial
- Has a life expectancy of < 1 year
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 StimulationAlso: PINS Stimulator System | Device | Deep Brain Stimulation, Placebo |
Primary outcome
Changes in the Hamilton Depression Rating Scale-17
Time frame: 1, 3, 6 and 12 months of stimulation
1 secondary outcome
The incidence of all adverse events
Time frame: 1, 3, 6 and 12 months of stimulation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2016.
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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.
Li Luming, PhD study chair
Tsinghua University
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Deep Brain Stimulation in people with Treatment-Resistant Depression, run by Beijing Pins Medical Co., Ltd.
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 14 Oct 2016. 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jia Fumin, PhD (+86 010-59361265, pins_medical@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the Hamilton Depression Rating Scale-17 (time frame: 1, 3, 6 and 12 months of stimulation). 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 14 Oct 2016.