Depressive Disorder, MajorNCT01331330
European Deep Brain Stimulation (DBS) Depression Study
A study testing Deep Brain Stimulation in people with Depressive Disorder, Major, run by Abbott Medical Devices at 5 sites in 3 countries.
Trial summary
To evaluate the effects of two different programming settings of deep brain stimulation (DBS) in the subgenual white matter (Brodmann Area 25 WM) as an adjunctive treatment for treatment resistant Major Depressive Disorder (TR-MDD), single or recurrent episode on mood as measured by the MADRS. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- Deep Brain Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 5 sitesin 3 countries
- Study dates
- May 2011to Jan 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 Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition, Text Revision, 2000 (DSM-IV-TR) criteria derived from the Mini International Neuropsychiatric Interview (MINI);
- First episode onset before age 45;
- Current episode > 12 month duration;
- In the current episode: Documented resistance to a minimum of 4 adequate depression treatments from at least 3 different categories;
- In adult lifetime (>21 year of age) have experience a period of wellness as defined by DSM IV criteria;
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- MADRS score ≥22 at 2 separate baseline visits, rated by 2 separate psychiatrists;
- Global Assessment of Functioning (GAF) score <50;
- Mini-mental state examination (MMSE) score >24;
- No change in current antidepressant medication regimen or medication free for at least 4 weeks prior to study entry;
- Able to give informed consent in accordance with institutional policies;
Who cannot join
- A diagnosis of 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, preferably screened via Structured Clinical Interview for DSM-IV Personality Disorders (SCID-II) at Baseline visit (optional);
- 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;
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
United Kingdom2 sites
King's College London
London, SE5 9RS
National Hospital for Neurology and Neurosurgery - UCL
London, WC1N 3
About this study
Official title: A Clinical Evaluation of Different Device Parameters for the Management of Patients With Treatment Resistant Major Depressive Disorder, Single or Recurrent Episode, With Deep Brain Stimulation
To evaluate the effects of two different programming settings of deep brain stimulation (DBS) in the subgenual white matter (Brodmann Area 25 WM) as an adjunctive treatment for treatment resistant Major Depressive Disorder (TR-MDD), single or recurrent episode on mood as measured by the MADRS.
Read the detailed description
The European Study was a prospective, multicenter, double-blind, randomized study comparing high frequency stimulation (130 Hz) to low frequency stimulation (20 Hz). Subjects underwent 2 baseline evaluations by 2 separate psychiatrists and were implanted with the Libra DBS system. Subjects were randomized to receive either high or low frequency stimulation. The primary endpoint was evaluated after 6 months of stimulation.
- Conditions
- Depressive Disorder, Major
- Being tested
- Deep Brain Stimulation
- Keywords
- Depressive Disorder, Unipolar, Implantable Stimulation Electrodes
- 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 StimulationDevice
Normal DBS Programming
Deep Brain StimulationDevice
Low Programming
| Study group | Role | What they receive |
|---|---|---|
| Group B | Active comparator | Low Programming Receives: Device: Deep Brain Stimulation |
| Group A | Experimental | Normal Programming Receives: Device: Deep Brain Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percent Change From Baseline in MADRS Score
The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item scale that measures depressive symptom severity. Scores range from 9 to 60, with a higher score indicating more severe depression.
Measured: 4, 7, 10 and 13 months
Secondary outcomes (9)
Mean Percent Change From Baseline in Hamilton Rating Scale for Depression (HDRS) Score
The Hamilton Depression Rating Scale is a 17-item scale that measures depressive symptom severity. Scores range from 0 to 52, with a higher score indicating more severe depression.
Measured: 4, 7, 10 and 13 month
Responder Rate (40% Reduction in MADRS)
Measured: 4, 7, 10 and 13 months
Mean Percent Change From Baseline in Hamilton Anxiety Rating Scale (HAMA-A) Score
Developed by M. Hamilton, this widely-used interview scale measures the severity of a patient's anxiety, based on 14 parameters, including anxious mood, tension, fears, insomnia, somatic complaints and behavior at the interview. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Measured: 4, 7, 10 and 13 months
Mean Percent Change From Baseline in GAF Score
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: 4, 7, 10 and 13 months
Mean Percent Change From Baseline in Quick Inventory of Depressive Symptoms - Self Report (QIDS-SR) Score
The Quick Inventory of Depressive Symptomatology Self Report (QIDS- SR) is a 16-question shortened self-test, derived from the 30-item Inventory of Depressive Symptomatology (IDS). Questions in the QIDS - SR-116 correlate with the nine Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (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. 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: 4, 7, 10 and 13 months
Mean Percent Change From Baseline in Clinical Global Impression of Severity and Improvement (CGI) Severity of Illness
The CGI severity of illness scale is a simple validated, single-item, 7-point self-reported categorical scale ranging from 0-7 where 0 indicates not assessed; 1 indicates normal, not at all ill; 2 indicates borderline mentally ill; 3 indicates mildly ill; 4 indicates moderately ill; 5 indicates markedly ill; 6 indicates severely ill; and 7 indicates among the most severely ill patients.
Measured: 4, 7, 10 and 13 months
Mean Total CGI for Global Improvement Score
The CGI global improvement score ranges from 0-7 where 0 indicates not assessed; 1 indicates very much improved; 2 indicates much improved; 3 indicates minimally improved; 4 indicates no change; 5 indicates minimally worse; 6 indicates much worse; and 7 indicates very much worse.
Measured: 4, 7, 10 and 13 months
Mean Percent Change From Baseline in Patient Global Impression Index (PGI) Severity of Illness
The CGI severity of illness scale is a simple validated, single-item, 7-point self-reported categorical scale ranging from 0-7 where 0 indicates not assessed; 1 indicates normal, not at all ill; 2 indicates borderline mentally ill; 3 indicates mildly ill; 4 indicates moderately ill; 5 indicates markedly ill; 6 indicates severely ill; and 7 indicates among the most severely ill patients.
Measured: 4, 7, 10 and 13 months
Mean Total PGI for Global Improvement Score
The CGI global improvement score ranges from 0-7 where 0 indicates not assessed; 1 indicates very much improved; 2 indicates much improved; 3 indicates minimally improved; 4 indicates no change; 5 indicates minimally worse; 6 indicates much worse; and 7 indicates very much worse.
Measured: 4, 7, 10 and 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2011 (estimated)
- Study startMay 2011
- Primary completionDec 2014
- Study completionJan 2015
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.
- 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicole Harbert, Study director, Abbott Medical Devices
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01331330
- Sponsor's protocol ID
- NM-09-035-EU-DB
- Status last verified
- Sep 2024
- First submitted
- 4 Apr 2011
- Last updated
- 14 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Evaluation of Different Device Parameters for the Management of Patients With Treatment Resistant Major Depressive Disorder, Single or Recurrent Episode, With Deep Brain Stimulation
- ClinicalTrials.gov ID
- NCT01331330
- Acronym / sponsor ID
- NM-09-035-EU-DB
- Conditions
- Depressive Disorder, Major
- Keywords
- Depressive Disorder, Unipolar, Implantable Stimulation Electrodes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 8 Apr 2011 (estimated)
- Results
- Posted 14 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the effects of two different programming settings of deep brain stimulation (DBS) in the subgenual white matter (Brodmann Area 25 WM) as an adjunctive treatment for treatment resistant Major Depressive Disorder (TR-MDD), single or recurrent episode on mood as measured by the MADRS.
Detailed description
The European Study was a prospective, multicenter, double-blind, randomized study comparing high frequency stimulation (130 Hz) to low frequency stimulation (20 Hz). Subjects underwent 2 baseline evaluations by 2 separate psychiatrists and were implanted with the Libra DBS system. Subjects were randomized to receive either high or low frequency stimulation. The primary endpoint was evaluated after 6 months of stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group B | Active comparator | Device: Deep Brain StimulationLow Programming |
| Group A | Experimental | Device: Deep Brain StimulationNormal Programming |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Men and women (non-pregnant) age is 21-70 years;
- Diagnosed with non-psychotic major depressive disorder, single or recurrent episode by Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition, Text Revision, 2000 (DSM-IV-TR) criteria derived from the Mini International Neuropsychiatric Interview (MINI);
- First episode onset before age 45;
- Current episode > 12 month duration;
- In the current episode: Documented resistance to a minimum of 4 adequate depression treatments from at least 3 different categories;
Key exclusion criteria (3 listed)
- A diagnosis of 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, preferably screened via Structured Clinical Interview for DSM-IV Personality Disorders (SCID-II) at Baseline visit (optional);
- 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;
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 StimulationNormal DBS Programming | Device | Group A |
| Deep Brain StimulationLow Programming | Device | Group B |
Primary outcome
Mean Percent Change From Baseline in MADRS Score
Time frame: 4, 7, 10 and 13 months
The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item scale that measures depressive symptom severity. Scores range from 9 to 60, with a higher score indicating more severe depression.
9 secondary outcomes
Mean Percent Change From Baseline in Hamilton Rating Scale for Depression (HDRS) Score
Time frame: 4, 7, 10 and 13 month
Responder Rate (40% Reduction in MADRS)
Time frame: 4, 7, 10 and 13 months
Mean Percent Change From Baseline in Hamilton Anxiety Rating Scale (HAMA-A) Score
Time frame: 4, 7, 10 and 13 months
Mean Percent Change From Baseline in GAF Score
Time frame: 4, 7, 10 and 13 months
Mean Percent Change From Baseline in Quick Inventory of Depressive Symptoms - Self Report (QIDS-SR) Score
Time frame: 4, 7, 10 and 13 months
Mean Percent Change From Baseline in Clinical Global Impression of Severity and Improvement (CGI) Severity of Illness
Time frame: 4, 7, 10 and 13 months
Mean Total CGI for Global Improvement Score
Time frame: 4, 7, 10 and 13 months
Mean Percent Change From Baseline in Patient Global Impression Index (PGI) Severity of Illness
Time frame: 4, 7, 10 and 13 months
Mean Total PGI for Global Improvement Score
Time frame: 4, 7, 10 and 13 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Nicole Harbert study director
Abbott Medical Devices
5 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 in people with Depressive Disorder, Major, run by Abbott Medical Devices at 5 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 11 inclusion and 3 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: finished, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France, United Kingdom, Israel. 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?
Yes. Results are posted in the registry (first posted 14 Nov 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?
Mean Percent Change From Baseline in MADRS Score (time frame: 4, 7, 10 and 13 months). 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 Nov 2024.