European Deep Brain Stimulation (DBS) Depression Study

NCT01331330 | Completed Results

• 1 other identifier: NM-09-035-EU-DB
• Study Type: interventional
• Target: 9
• Locations: 3 countries
• Sites: 5

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.

Conditions

Depressive Disorder, Major

Keywords

Depressive Disorder; Unipolar; Implantable Stimulation Electrodes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Mean Percent Change From Baseline in Hamilton Rating Scale for Depression (HDRS) Score

  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

  4, 7, 10 and 13 months

• Mean Percent Change From Baseline in GAF Score

  4, 7, 10 and 13 months

• Mean Percent Change From Baseline in Quick Inventory of Depressive Symptoms - Self Report (QIDS-SR) Score

  4, 7, 10 and 13 months

Study Arms (2)

Group B

ACTIVE COMPARATOR

Low Programming

Device: Deep Brain Stimulation

Group A

EXPERIMENTAL

Normal Programming

Device: Deep Brain Stimulation

Interventions

Deep Brain Stimulation DEVICE

Normal DBS Programming

Group A

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (5)

CHU Pasteur

Nice, 06002, France

Location

Hôpital La Pitié Salpêtrière

Paris, 75651, France

Location

Hadassah-Hebrew University Medical Center

Jerusalem, 91120, Israel

Location

King's College London

London, SE5 9RS, United Kingdom

Location

National Hospital for Neurology and Neurosurgery - UCL

London, WC1N 3, United Kingdom

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depressive Disorder

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Limitations and Caveats

The original study planned to enroll 60 subjects from a minimum of 8 sites. The study enrolled 9 patients from 3 sites. Recruitment was prematurely stopped due to slow enrollment.

Results Point of Contact

• Title: Devyani Nanduri
• Organization: Abbott Medical Devices

devyani.nanduri@abbott.com

+1 510-561-4328

Study Officials

• Nicole Harbert

  Abbott Medical Devices

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2011
• First Posted: April 8, 2011
• Study Start: May 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: January 1, 2015
• Last Updated: November 14, 2024
• Results First Posted: November 14, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2); IL (1); GB (2)