Depressive Disorder, MajorNCT00617162
Deep Brain Stimulation for Major Depressive Disorder
A study testing Deep Brain Stimulation, Libra Deep Brain Stimulation System in people with Depressive Disorder, Major and Unipolar Depression, run by Abbott Medical Devices at 13 sites in 3 countries.
Trial summary
This study is designed as a prospective, multi-centered, double-blind, randomized, controlled 12-month pivotal study to evaluate the safety and efficacy of the ANS Libra® Deep Brain Stimulation System for patients with major depressive disorder who have failed at least 4 treatments in the current episode. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Depressive Disorder, Major, Unipolar Depression
- What is being tested?
- Deep Brain Stimulation, Libra Deep Brain Stimulation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 13 sitesin 3 countries
- Study dates
- Mar 2008to Jun 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women (non-pregnant) age is 21-70 years;
- Diagnosed with non-psychotic major depressive disorder, single or recurrent episode by DSM-IV-TR criteria derived from the MINI;
- 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;
- In Lifetime: Received a course of psychotherapy for depression;
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- Montgomery Asberg Depression Rating Scale (MADRS) of ≥ 22 at 3 separate baseline visits, rated by 2 separate psychiatrists, Baseline 2 and Baseline 3 MADRS scores cannot be separated by > 6 weeks and cannot improve ≥ 20%;
- Global Assessment of Function, score <50;
- Modified mini-mental state examination (MMSE) score ≥24;
- No change in current antidepressant medication regimen or medication free ≥4 weeks prior to study entry (with exception to sleep, cholesterol, blood pressure, sexual dysfunction, non-migraine headache medication, or medication for other medical reasons not related to depression, in which changes to dose or type will be allowed during course of study);
- Able to give informed consent in accordance with institutional policies;
- Able to comply with all testing and follow-up requirements as defined by the study protocol;
- Must be determined medically stable by surgeon, to undergo deep brain stimulation surgical procedure.
- Must have platelet count, PT and PTT within normal limits of the laboratory.
- During last 6 months in the current episode documented treatment under the care of a licensed psychiatrist/psychologist.
Who cannot join
- A diagnosis of a bipolar I or bipolar II disorder by DSM-IV-TR criteria, derived from the MINI;
- Meets criteria for borderline or antisocial personality disorder in the last 12 months by DSM-IV-TR criteria, derived from the Cluster B Personality Disorders Sections 301.7 - 301.83, and screened via SCID-II at Baseline visit;
- In the current depressive episode, has been diagnosed with General Anxiety Disorder (GAD) - as defined by the DSM-IV-TR, and GAD is the primary diagnosis;
- Has an intracranial Central Nervous System (CNS) disease that impairs motor, sensory or cognitive function or that requires intermittent or chronic medication (e.g., Parkinson's Disease, chronic migraine, stroke, Huntington's, head trauma, etc.) with exception to non-migraine headaches;
- Has been diagnosed with fibromyalgia or has a current condition which requires chronic pain narcotic usage (e.g. morphine, methadone);
- Has been currently diagnosed with chronic fatigue syndrome;
Show all 26Show fewer
- Substantial suicidal risk as defined by (1) MADRS item 10 score of 5 or 6, (2) a current plan and intent,(3) clinician judgment that there is a clear immediate intent for self-harm, (4) more than 3 suicide attempts within the last 12 months;
- Co-morbid obsessive compulsive disorder, posttraumatic stress disorder, panic disorder, bulimia or anorexia nervosa if previously present, must be in remission for 6 months as defined by DSM-IV-TR criteria, derived from the MINI;
- Alcohol, medication, or illegal substance dependence or abuse within last 12 months derived from the MINI;
- Diagnosis of sleep apnea confirmed by a sleep test that is not adequately treated;
- Advanced cardiovascular disease which renders anesthesia and surgery as unsafe as determined by neurosurgeon;
- Clinically relevant abnormality (e.g. tumor or growth) on study MRI;
- Has cardiac pacemaker/defibrillator or other implanted active stimulator;
- Has a medical condition requiring a repetitive MRI body scan;
- Requires chemotherapy for the treatment of malignancy or requiring chronic oral or intravenous (immunosuppressive or) steroid therapy;
- Is unable to comply with study visit schedule and timeline;
- Past ablative or relevant intracranial surgery;
- A female lactating or of child bearing potential, with a positive pregnancy test or not using adequate contraception;
- Lifetime psychotic disorders, schizophrenia, or schizoaffective disorder defined by DSM-IV-TR;
- Psychotic features in current depressive episode as diagnosed by DSM-IV-TR criteria;
- Other medical conditions likely to require hospitalization within the next year;
- Received ECT within 3 months prior to enrollment, or requires ECT for the duration of the study;
- Has a history of epilepsy or history of status epilepticus;
- Plans to use diathermy;
- Has any metallic implants such as aneurysm clips or cochlear implants;
- Currently participating in another investigational device, drug or surgical trial
Trial locations and contacts
13 sites in 3 countries.
13 sites in 3 countries
United States11 sites
Medical Univeristy of South Carolina (MUSC)
Charleston, South Carolina, 29425
Alexian Brothers Behavioral Health Hospital
Chicago, Illinois, 60169
UT Southwestern Medical Center
Dallas, Texas, 75390
The Zucker Hillside Hospital
Glen Oaks, New York, 11004
University of Minnesota Medical School
Minneapolis, Minnesota, 55455
Vanderbilt University
Nashville, Tennessee, 37212
Columbia University Medical Center
New York, New York, 10032
Virginia Commonwealth University
Richmond, Virginia, 23298
Swedish Neuroscience Institute
Seattle, Washington, 98122
Stanford University School of Medicine
Stanford, California, 94305
University of Massachusetts Medical School
Worcester, Massachusetts, 01605
Canada1 site
University of British Columbia
Vancouver, British Columbia, V6T 2A1
About this study
Official title: A Clinical Evaluation for the Management of Patients With Major Depressive Disorder, Single or Recurrent Episode, With Deep Brain Stimulation
This study is designed as a prospective, multi-centered, double-blind, randomized, controlled 12-month pivotal study to evaluate the safety and efficacy of the ANS Libra® Deep Brain Stimulation System for patients with major depressive disorder who have failed at least 4 treatments in the current episode. The primary outcome assessment will occur at 6 months: however, all patients will be followed for 1 year. A total of 201 patients will be randomized from up to 20 sites.
Each potential patient will be pre-screened according to the inclusion/exclusion criteria. A narrative of what study participation entails, will be used to educate potential participants on study requirements. Prior to on-site baseline evaluations, the patient will sign the informed consent. Patients will then undergo 3 baseline evaluations, with each of these evaluations to occur no less than 2 weeks apart from each other. The first 2 baseline visit evaluations will be performed by separate psychiatrists in order to confirm the patient's diagnosis. All patients will be scheduled for surgery, to occur no less than two weeks and no more than 1 month after final baseline evaluation, to implant the ANS Libra® Deep Brain Stimulation system. After device implantation, patients will be randomly assigned to 1 of 2 groups in a 2:1 ratio (Active Treatment Group \& Control Group).
After system implant (Week 0), the patient will return to clinic approximately 2 weeks after surgery for evaluation and treatment randomization into either Group 1 or Group 2 (Group 1 = Active Treatment Group; Group 2 = Control Group). Patient will then return to clinic for subsequent evaluations at 2 weeks, 4 weeks, 6 weeks, 8 weeks, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, and 1 year post system implantation.
- Conditions
- Depressive Disorder, Major, Unipolar Depression
- Being tested
- Deep Brain Stimulation, Libra Deep Brain Stimulation System
- Keywords
- C-07-01, BROADEN™, Deep Brain Stimulation, Major Depressive Disorder, Unipolar Depression
- Medical subject headings
- Depressive Disorder, Major, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain Stimulation, Libra Deep Brain Stimulation SystemDevice
Also called Libra Deep Brain Stimulation System
DBS Active Treatment Group - implanted with investigational device and activated for stimulation
Deep Brain Stimulation, Libra Deep Brain Stimulation SystemDevice
Also called Libra Deep brain Stimulation System
implanted with investigational device, but will not receive active stimulation for the first 6 months of the study
| Study group | Role | What they receive |
|---|---|---|
| DBS Active Treatment Group | Experimental | Deep Brain Stimulation, Libra Deep Brain Stimulation System: DBS Active Treatment Group - implanted with investigational device and activated for stimulation Receives: Device: Deep Brain Stimulation, Libra Deep Brain Stimulation System |
| DBS Control Group | Placebo comparator | Deep Brain Stimulation, Libra Deep Brain Stimulation System: implanted with investigational device, but will not receive active stimulation for the first 6 months of the study Receives: Device: Deep Brain Stimulation, Libra Deep Brain Stimulation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery and Asberg Depression Rating Scale (MADRS) Score at Baseline and the Average of Months 4, 5, and 6
The MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The lower a score the less symptom severity is seen.
Measured: Baseline to 6 months
Secondary outcomes (8)
Baseline MADRS to MADRS at 1 Year
The MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The lower a score the less symptom severity is seen.
Measured: Baseline to 1 year
Number of Participants With Adverse Events (i.e., Hospitalization Due to Worsening Depression, Suicidal Ideation or Behavior, Medical Treatment, and Device Related Events) That Occur Over Study Duration
Measured: 6 months-1 year
Global Assessment Scale (GAF) Score at Baseline and 1 Year
The Global Assessment Scale (GAF) is a hypothetical continuum of mental health illness that looks at psychological, social, and occupational functioning. It measures how much a person's symptoms affect their day to-day life on a scale of 0 to 100. A score of 100-91 indicates no symptoms, 90-81 indicates absent minimal symptoms, 80-71 indicates symptoms that are transient and reactions expectable to psychosocial stressors, 70-61 indicates mild symptoms, 60-51 indicates moderate symptoms, 50-41 indicates serious symptoms, 40-31 indicates some impairment in reality testing or communication OR major impairment in several areas, 30-21 indicates delusions or hallucinations, 20-11 indicates danger of hurting self or others OR occasionally fails to maintain personal hygiene, 10-1 indicates persistent danger of severely hurting self or others OR persistent inability to maintain minimal personal hygiene OR serious suicidal act with clear expectation of death and 0 indicates inadequate data.
Measured: 1 year
Hamilton Rating Scale for Depression - 17 Item (HRSD-17) Score at Baseline and 6 Months
The Hamilton Rating Scale for Depression - 17 item (HDRS-17) ranging from 0-52 used to assess potential changes in the severity of depressive symptoms (Hamilton 1960; Hamilton 1967). It is used to evaluate depressed mood, vegetative and cognitive symptoms of depression, and co-morbid anxiety symptoms. Scoring is based on the 17-itemscale and scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression; the maximum score being 52 on the17-point scale.
Measured: 6 months
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Score From Baseline to 1 Year
The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) is a self-report instrument designed to measure the degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning. There are 16 areas of functioning, each scored from 1 (very poor) to 5 (very good). The range of scores is 16-80, with lower scores representing lower functioning and satisfaction.
Measured: 1 year
Inventory of Depressive Symptomology (IDS-C30) Score From Baseline to 1 Year
The construction of the Inventory of Depressive Symptomology (IDS-C30) was intended to remedy deficits in the Hamilton Scale for Depression (HRSD-17) and Montgomery and Asberg (MADRS) depression rating scales by, among others, including all nine symptom domains needed to diagnose a DSM-IV major depressive episode in order to assess symptom remission, improve ability to detect milder levels of symptoms than the HRSD-17, and provide unconfined and more equivalent weighting among items. There are two versions of the IDS with identical items: a clinician rating (IDS-C30) and a self-report (IDS-SR30). Each of the 30 items is rated from 0 to 3, with increasing severity represented by a higher rating. (Rush et al. 1996). When complete, the IDS-C30 and IDS-SR30 are scored by summing responses to 28 of the 30 items to obtain a total score ranging from 0 to 84. Either appetite increase or decrease, but not both, are used to calculate the total score.
Measured: 1 year
Quick Inventory of Depressive Symptomatology (QIDS-SR) Scores From Baseline to 1 Year
The Quick Inventory of Depressive Symptomatology Self Report (QIDS- SR) is a 16-question shortened self-test, derived from the 30-item IDS. Questions in the QIDS - SR-116 correlate with the nine DSM-IV symptom criterion domains, including: Sleep disturbance (initial, middle, and late insomnia or hypersomnia) (Q 1 - 4), Sad mood (Q 5), Decrease/increase in appetite/weight (Q 6 - 9), Concentration (Q 10), Self-criticism (Q 11), Suicidal ideation (Q 12), Interest (Q 13), Energy/fatigue (Q 14), Psychomotor agitation/retardation (Q 15 - 16). The severity of depression can be judged based on the total score ranging from 1-27. A score of 1-5 indicates No depression, 6-10 indicates Mild depression,11-15 indicates Moderate depression, 16-20 indicates Severe depression and 21-27 indicates Very severe depression.
Measured: 1 year
Work and Social Adjustment Scale (WSAS) Score From Baseline to 1 Year
The WSAS is a modification of a scale introduced by Hafner and Marks (1976), consisting of 0-8 point ratings of the extent to which symptoms interfere with five areas of daily functioning: work, home management, private leisure, social leisure, and family relationships. It is a well-validated, widely used self-report measure. Additional time points include weeks 4, 8, 12, 16, and 40. A total score calculated as a sum of all items (possible range 0-40) was used in the analyses with higher scores indicating more impairment.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study startMar 2008
- Primary completionJun 2014
- Study completionJun 2015
Why it stopped: Business reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- DeLea Peichel, Study director, Abbott Medical Devices
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00617162
- Sponsor's protocol ID
- C-07-01
- Status last verified
- Apr 2024
- First submitted
- 26 Dec 2007
- Last updated
- 8 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Holtzheimer PE, Husain MM, Lisanby SH, Taylor SF, Whitworth LA, McClintock S, Slavin KV, Berman J, McKhann GM, Patil PG, Rittberg BR, Abosch A, Pandurangi AK, Holloway KL, Lam RW, Honey CR, Neimat JS, Henderson JM, DeBattista C, Rothschild AJ, Pilitsis JG, Espinoza RT, Petrides G, Mogilner AY, Matthews K, Peichel D, Gross RE, Hamani C, Lozano AM, Mayberg HS. Subcallosal cingulate deep brain stimulation for treatment-resistant depression: a multisite, randomised, sham-controlled trial. Lancet Psychiatry. 2017 Nov;4(11):839-849. doi: 10.1016/S2215-0366(17)30371-1. Epub 2017 Oct 4.
PubMed 28988904
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Evaluation for the Management of Patients With Major Depressive Disorder, Single or Recurrent Episode, With Deep Brain Stimulation
- ClinicalTrials.gov ID
- NCT00617162
- Acronym / sponsor ID
- C-07-01
- Conditions
- Depressive Disorder, Major, Unipolar Depression
- Keywords
- C-07-01, BROADEN™, Deep Brain Stimulation, Major Depressive Disorder, Unipolar Depression
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business reasons
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 15 Feb 2008 (estimated)
- Results
- Posted 8 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed as a prospective, multi-centered, double-blind, randomized, controlled 12-month pivotal study to evaluate the safety and efficacy of the ANS Libra® Deep Brain Stimulation System for patients with major depressive disorder who have failed at least 4 treatments in the current episode. The primary outcome assessment will occur at 6 months: however, all patients will be followed for 1 year. A total of 201 patients will be randomized from up to 20 sites.
Each potential patient will be pre-screened according to the inclusion/exclusion criteria. A narrative of what study participation entails, will be used to educate potential participants on study requirements. Prior to on-site baseline evaluations, the patient will sign the informed consent. Patients will then undergo 3 baseline evaluations, with each of these evaluations to occur no less than 2 weeks apart from each other. The first 2 baseline visit evaluations will be performed by separate psychiatrists in order to confirm the patient's diagnosis. All patients will be scheduled for surgery, to occur no less than two weeks and no more than 1 month after final baseline evaluation, to implant the ANS Libra® Deep Brain Stimulation system. After device implantation, patients will be randomly assigned to 1 of 2 groups in a 2:1 ratio (Active Treatment Group \& Control Group).
After system implant (Week 0), the patient will return to clinic approximately 2 weeks after surgery for evaluation and treatment randomization into either Group 1 or Group 2 (Group 1 = Active Treatment Group; Group 2 = Control Group). Patient will then return to clinic for subsequent evaluations at 2 weeks, 4 weeks, 6 weeks, 8 weeks, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, and 1 year post system implantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DBS Active Treatment Group | Experimental | Device: Deep Brain Stimulation, Libra Deep Brain Stimulation SystemDeep Brain Stimulation, Libra Deep Brain Stimulation System: DBS Active Treatment Group - implanted with investigational device and activated for stimulation |
| DBS Control Group | Placebo comparator | Device: Deep Brain Stimulation, Libra Deep Brain Stimulation SystemDeep Brain Stimulation, Libra Deep Brain Stimulation System: implanted with investigational device, but will not receive active stimulation for the first 6 months of the study |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Men and women (non-pregnant) age is 21-70 years;
- Diagnosed with non-psychotic major depressive disorder, single or recurrent episode by DSM-IV-TR criteria derived from the MINI;
- 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;
Key exclusion criteria (26 listed)
- A diagnosis of a bipolar I or bipolar II disorder by DSM-IV-TR criteria, derived from the MINI;
- Meets criteria for borderline or antisocial personality disorder in the last 12 months by DSM-IV-TR criteria, derived from the Cluster B Personality Disorders Sections 301.7 - 301.83, and screened via SCID-II at Baseline visit;
- In the current depressive episode, has been diagnosed with General Anxiety Disorder (GAD) - as defined by the DSM-IV-TR, and GAD is the primary diagnosis;
- Has an intracranial Central Nervous System (CNS) disease that impairs motor, sensory or cognitive function or that requires intermittent or chronic medication (e.g., Parkinson's Disease, chronic migraine, stroke, Huntington's, head trauma, etc.) with exception to non-migraine headaches;
- Has been diagnosed with fibromyalgia or has a current condition which requires chronic pain narcotic usage (e.g. morphine, methadone);
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 Stimulation, Libra Deep Brain Stimulation SystemAlso: Libra Deep Brain Stimulation SystemDBS Active Treatment Group - implanted with investigational device and activated for stimulation | Device | DBS Active Treatment Group |
| Deep Brain Stimulation, Libra Deep Brain Stimulation SystemAlso: Libra Deep brain Stimulation Systemimplanted with investigational device, but will not receive active stimulation for the first 6 months of the study | Device | DBS Control Group |
Primary outcome
Montgomery and Asberg Depression Rating Scale (MADRS) Score at Baseline and the Average of Months 4, 5, and 6
Time frame: Baseline to 6 months
The MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The lower a score the less symptom severity is seen.
8 secondary outcomes
Baseline MADRS to MADRS at 1 Year
Time frame: Baseline to 1 year
Number of Participants With Adverse Events (i.e., Hospitalization Due to Worsening Depression, Suicidal Ideation or Behavior, Medical Treatment, and Device Related Events) That Occur Over Study Duration
Time frame: 6 months-1 year
Global Assessment Scale (GAF) Score at Baseline and 1 Year
Time frame: 1 year
Hamilton Rating Scale for Depression - 17 Item (HRSD-17) Score at Baseline and 6 Months
Time frame: 6 months
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Score From Baseline to 1 Year
Time frame: 1 year
Inventory of Depressive Symptomology (IDS-C30) Score From Baseline to 1 Year
Time frame: 1 year
Quick Inventory of Depressive Symptomatology (QIDS-SR) Scores From Baseline to 1 Year
Time frame: 1 year
Work and Social Adjustment Scale (WSAS) Score From Baseline to 1 Year
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28988904Holtzheimer PE, Husain MM, Lisanby SH, Taylor SF, Whitworth LA, McClintock S, Slavin KV, Berman J, McKhann GM, Patil PG, Rittberg BR, Abosch A, Pandurangi AK, Holloway KL, Lam RW, Honey CR, Neimat JS, Henderson JM, DeBattista C, Rothschild AJ, Pilitsis JG, Espinoza RT, Petrides G, Mogilner AY, Matthews K, Peichel D, Gross RE, Hamani C, Lozano AM, Mayberg HS. Subcallosal cingulate deep brain stimulation for treatment-resistant depression: a multisite, randomised, sham-controlled trial. Lancet Psychiatry. 2017 Nov;4(11):839-849. doi: 10.1016/S2215-0366(17)30371-1. Epub 2017 Oct 4.
- Individual participant dataSharing planned: No
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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.
DeLea Peichel study director
Abbott Medical Devices
13 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Brain Stimulation, Libra Deep Brain Stimulation System in people with Depressive Disorder, Major and Unipolar Depression, run by Abbott Medical Devices at 13 sites in 3 countries.
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 15 inclusion and 26 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: stopped early, as of the sponsor's last update on 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Canada, United Kingdom. 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. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montgomery and Asberg Depression Rating Scale (MADRS) Score at Baseline and the Average of Months 4, 5, and 6 (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00617162, which also lists 1 linked publication.
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 Apr 2024.