European Deep Brain Stimulation (DBS) Depression Study

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01331330
• Other study ID #: NM-09-035-EU-DB
• Status: Completed
• Phase: N/A
• First received: April 4, 2011
• Last updated: May 18, 2015
• Start date: May 2011
• Est. completion date: January 2015

Study information

• Verified date: May 2015
• Source: St. Jude Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 TR-MDD, single or recurrent episode on mood as measured by the MADRS.

Recruitment information / eligibility

• 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;

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

Device:
• Deep Brain Stimulation
Normal DBS Programming
• Deep Brain Stimulation
Low Programming

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
St. Jude Medical

Countries where clinical trial is conducted

France,  Israel,  United Kingdom, 

Outcome

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