Clinical trial NCT01331330: European Deep Brain Stimulation (DBS) Depression 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Disorder, Major
Keywords: Depressive Disorder
Unipolar
Implantable Stimulation Electrodes
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2011-04-08
Enrollment: 9
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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.

Eligibility 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 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;
* 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;

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 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;

Primary outcomes:
measure: Mean Percent Change From Baseline in MADRS Score
timeFrame: 4, 7, 10 and 13 months
Secondary outcomes:
measure: Mean Percent Change From Baseline in Hamilton Rating Scale for Depression (HDRS) Score
timeFrame: 4, 7, 10 and 13 month
measure: Responder Rate (40% Reduction in MADRS)
timeFrame: 4, 7, 10 and 13 months
measure: Mean Percent Change From Baseline in Hamilton Anxiety Rating Scale (HAMA-A) Score
timeFrame: 4, 7, 10 and 13 months
measure: Mean Percent Change From Baseline in GAF Score
timeFrame: 4, 7, 10 and 13 months
measure: Mean Percent Change From Baseline in Quick Inventory of Depressive Symptoms - Self Report (QIDS-SR) Score
timeFrame: 4, 7, 10 and 13 months
measure: Mean Percent Change From Baseline in Clinical Global Impression of Severity and Improvement (CGI) Severity of Illness
timeFrame: 4, 7, 10 and 13 months
measure: Mean Total CGI for Global Improvement Score
timeFrame: 4, 7, 10 and 13 months
measure: Mean Percent Change From Baseline in Patient Global Impression Index (PGI) Severity of Illness
timeFrame: 4, 7, 10 and 13 months
measure: Mean Total PGI for Global Improvement Score
timeFrame: 4, 7, 10 and 13 months
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU Pasteur
city: Paris
country: France
facility: Hôpital La Pitié Salpêtrière
city: Jerusalem
country: Israel
facility: Hadassah-Hebrew University Medical Center
city: London
country: United Kingdom
facility: King's College London
city: London
country: United Kingdom
facility: National Hospital for Neurology and Neurosurgery - UCL
Study officials:
affiliation: Abbott Medical Devices
name: Nicole Harbert
role: STUDY_DIRECTOR
References: