Depressive Disorder, Major Clinical Trial
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
Verified date | May 2015 |
Source | St. Jude Medical |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 TR-MDD, single or recurrent episode on mood as measured by the MADRS.
Status | Completed |
Enrollment | 9 |
Est. completion date | January 2015 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 70 Years |
Eligibility |
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; |
Country | Name | City | State |
---|---|---|---|
France | CHU Pasteur | Nice | |
France | Hôpital La Pitié Salpêtrière | Paris | |
Israel | Hadassah-Hebrew University Medical Center | Jerusalem | |
United Kingdom | King's College London | London | |
United Kingdom | National Hospital for Neurology and Neurosurgery - UCL | London |
Lead Sponsor | Collaborator |
---|---|
St. Jude Medical |
France, Israel, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of change from mean baseline values in MADRS score | 6 Months | ||
Secondary | Percentage of change from baseline value of HDRS | 3, 6, 9, and 12 months |
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