European Deep Brain Stimulation (DBS) Depression Study

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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.

Condition or disease	Intervention/treatment	Phase
Depressive Disorder, Major	Device: Deep Brain Stimulation	Not Applicable

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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)
Experimental: Group A; Normal Programming	Device: Deep Brain Stimulation; Normal DBS Programming; Other Name: Libra Deep Brain Stimulation System (St. Jude Medical Neuromodulation Division)

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Percentage of change from mean baseline values in MADRS score [ Time Frame: 6 Months ]

Secondary Outcome Measures :

1. Percentage of change from baseline value of HDRS [ Time Frame: 3, 6, 9, and 12 months ]

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	21 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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;

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

St. Jude Medical

Investigators

Study Director:	DeLea Peichel	St. Jude Medical

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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