European Deep Brain Stimulation (DBS) Depression Study

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

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.

Study Overview

• Status: Completed
• Conditions: Depressive Disorder, Major
• Intervention / Treatment: Device: Deep Brain Stimulation; Device: Deep Brain Stimulation

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nice, France, 06002
    • CHU Pasteur
  • Paris, France, 75651
    • Hôpital La Pitié Salpêtrière
• Israel
  • Jerusalem, Israel, 91120
    • Hadassah-Hebrew University Medical Center
• United Kingdom
  • London, United Kingdom, SE5 9RS
    • King's College London
  • London, United Kingdom, WC1N 3
    • National Hospital for Neurology and Neurosurgery - UCL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group B; Low Programming	Device: Deep Brain Stimulation; Normal DBS Programming; Other Names: Libra Deep Brain Stimulation System (St. Jude Medical Neuromodulation Division); Device: Deep Brain Stimulation; Low Programming; Other Names: Libra Deep Brain Stimulation System(St. Jude Medical Neuromodulation Division)
Experimental: Group A; Normal Programming	Device: Deep Brain Stimulation; Normal DBS Programming; Other Names: Libra Deep Brain Stimulation System (St. Jude Medical Neuromodulation Division); Device: Deep Brain Stimulation; Low Programming; Other Names: Libra Deep Brain Stimulation System(St. Jude Medical Neuromodulation Division)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Percent Change From Baseline in MADRS Score	The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item scale that measures depressive symptom severity. Scores range from 9 to 60, with a higher score indicating more severe depression.	4, 7, 10 and 13 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Percent Change From Baseline in Hamilton Rating Scale for Depression (HDRS) Score	The Hamilton Depression Rating Scale is a 17-item scale that measures depressive symptom severity. Scores range from 0 to 52, with a higher score indicating more severe depression.	4, 7, 10 and 13 month
Responder Rate (40% Reduction in MADRS)		4, 7, 10 and 13 months
Mean Percent Change From Baseline in Hamilton Anxiety Rating Scale (HAMA-A) Score	Developed by M. Hamilton, this widely-used interview scale measures the severity of a patient's anxiety, based on 14 parameters, including anxious mood, tension, fears, insomnia, somatic complaints and behavior at the interview. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.	4, 7, 10 and 13 months
Mean Percent Change From Baseline in GAF Score	The Global Assessment Scale (GAF) is a hypothetical continuum of mental health illness that looks at psychological, social, and occupational functioning. It measures how much a person's symptoms affect their day-to-day life on a scale of 0 to 100. A score of 100-91 indicates no symptoms, 90-81 indicates absent minimal symptoms, 80-71 indicates symptoms that are transient and reactions expectable to psychosocial stressors, 70-61 indicates mild symptoms, 60-51 indicates moderate symptoms, 50-41 indicates serious symptoms, 40-31 indicates some impairment in reality testing or communication OR major impairment in several areas, 30-21 indicates delusions or hallucinations, 20-11 indicates danger of hurting self or others OR occasionally fails to maintain personal hygiene, 10-1 indicates persistent danger of severely hurting self or others OR persistent inability to maintain minimal personal hygiene OR serious suicidal act with clear expectation of death and 0 indicates inadequate data.	4, 7, 10 and 13 months
Mean Percent Change From Baseline in Quick Inventory of Depressive Symptoms - Self Report (QIDS-SR) Score	The Quick Inventory of Depressive Symptomatology Self Report (QIDS- SR) is a 16-question shortened self-test, derived from the 30-item Inventory of Depressive Symptomatology (IDS). Questions in the QIDS - SR-116 correlate with the nine Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) symptom criterion domains, Including: Sleep disturbance (initial, middle, and late insomnia or hypersomnia) (Q 1 - 4), Sad mood (Q 5), Decrease/increase in appetite/weight (Q 6 - 9), Concentration (Q 10), Self-criticism (Q 11), Suicidal ideation (Q 12), Interest (Q 13), Energy/fatigue (Q 14), Psychomotor agitation/retardation (Q 15 - 16). The severity of depression can be judged based on the total score. A score of 1-5 indicates No depression, 6-10 indicates Mild depression, 11-15 indicates Moderate depression, 16-20 indicates Severe depression and 21-27 indicates Very severe depression.	4, 7, 10 and 13 months
Mean Percent Change From Baseline in Clinical Global Impression of Severity and Improvement (CGI) Severity of Illness	The CGI severity of illness scale is a simple validated, single-item, 7-point self-reported categorical scale ranging from 0-7 where 0 indicates not assessed; 1 indicates normal, not at all ill; 2 indicates borderline mentally ill; 3 indicates mildly ill; 4 indicates moderately ill; 5 indicates markedly ill; 6 indicates severely ill; and 7 indicates among the most severely ill patients.	4, 7, 10 and 13 months
Mean Total CGI for Global Improvement Score	The CGI global improvement score ranges from 0-7 where 0 indicates not assessed; 1 indicates very much improved; 2 indicates much improved; 3 indicates minimally improved; 4 indicates no change; 5 indicates minimally worse; 6 indicates much worse; and 7 indicates very much worse.	4, 7, 10 and 13 months
Mean Percent Change From Baseline in Patient Global Impression Index (PGI) Severity of Illness	The CGI severity of illness scale is a simple validated, single-item, 7-point self-reported categorical scale ranging from 0-7 where 0 indicates not assessed; 1 indicates normal, not at all ill; 2 indicates borderline mentally ill; 3 indicates mildly ill; 4 indicates moderately ill; 5 indicates markedly ill; 6 indicates severely ill; and 7 indicates among the most severely ill patients.	4, 7, 10 and 13 months
Mean Total PGI for Global Improvement Score	The CGI global improvement score ranges from 0-7 where 0 indicates not assessed; 1 indicates very much improved; 2 indicates much improved; 3 indicates minimally improved; 4 indicates no change; 5 indicates minimally worse; 6 indicates much worse; and 7 indicates very much worse.	4, 7, 10 and 13 months

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Director: Nicole Harbert, Abbott Medical Devices

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: April 4, 2011
• First Submitted That Met QC Criteria: April 6, 2011
• First Posted (Estimated): April 8, 2011

Study Record Updates

• Last Update Posted (Actual): November 14, 2024
• Last Update Submitted That Met QC Criteria: September 5, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Depressive Disorder; Unipolar; Implantable Stimulation Electrodes
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: NM-09-035-EU-DB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO