European Deep Brain Stimulation (DBS) Depression Study
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ClinicalTrials.gov Identifier: NCT01331330 |
Recruitment Status
:
Completed
First Posted
: April 8, 2011
Last Update Posted
: May 19, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Depressive Disorder, Major | Device: Deep Brain Stimulation | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 9 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | May 2011 |
Actual Primary Completion Date : | December 2014 |
Actual Study Completion Date : | January 2015 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Group B
Low Programming
|
Device: Deep Brain Stimulation
Low Programming
Other Name: Libra Deep Brain Stimulation System(St. Jude Medical Neuromodulation Division)
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Experimental: Group A
Normal Programming
|
Device: Deep Brain Stimulation
Normal DBS Programming
Other Name: Libra Deep Brain Stimulation System (St. Jude Medical Neuromodulation Division)
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- Percentage of change from mean baseline values in MADRS score [ Time Frame: 6 Months ]
- Percentage of change from baseline value of HDRS [ Time Frame: 3, 6, 9, and 12 months ]

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Ages Eligible for Study: | 21 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 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;
- MADRS score ≥22 at 2 separate baseline visits, rated by 2 separate psychiatrists;
- 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;
Exclusion Criteria:
- 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 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;

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01331330
France | |
CHU Pasteur | |
Nice, France, 06002 | |
Hôpital La Pitié Salpêtrière | |
Paris, France, 75651 | |
Israel | |
Hadassah-Hebrew University Medical Center | |
Jerusalem, Israel, 91120 | |
United Kingdom | |
King's College London | |
London, United Kingdom, SE5 9RS | |
National Hospital for Neurology and Neurosurgery - UCL | |
London, United Kingdom, WC1N 3 |
Study Director: | DeLea Peichel | St. Jude Medical |
Responsible Party: | St. Jude Medical |
ClinicalTrials.gov Identifier: | NCT01331330 History of Changes |
Other Study ID Numbers: |
NM-09-035-EU-DB |
First Posted: | April 8, 2011 Key Record Dates |
Last Update Posted: | May 19, 2015 |
Last Verified: | May 2015 |
Keywords provided by St. Jude Medical:
Depressive Disorder Unipolar Implantable Stimulation Electrodes |
Additional relevant MeSH terms:
Depressive Disorder Depression Depressive Disorder, Major |
Mood Disorders Mental Disorders Behavioral Symptoms |