N/A
N=9
European Deep Brain Stimulation (DBS) Depression Study
Depressive Disorder, Major
Bottom Line
View on ClinicalTrials.gov: NCT01331330 ↗Enrolled (actual)
9
Serious AEs
11.1%
Results posted
Nov 2024
Primary outcome: Primary: Mean Percent Change From Baseline in MADRS Score — -7.7; -7.4; -8.8; -6.2 percentage change from baseline
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Deep Brain Stimulation (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Percent Change From Baseline in MADRS Score |
-7.7; -7.4; -8.8; -6.2; -42.9; -22.7 | — |
| SECONDARY Mean Percent Change From Baseline in Hamilton Rating Scale for Depression (HDRS) Score |
-6.1; -28.1; -3.0; -12.9; -46.8; -16.5 | — |
| SECONDARY Responder Rate (40% Reduction in MADRS) |
0; 0; 0; 0; 3; 0 | — |
| SECONDARY Mean Percent Change From Baseline in Hamilton Anxiety Rating Scale (HAMA-A) Score |
-8.3; -9.5; -5.6; -5.9; -26.2; -21.9 | — |
| SECONDARY Mean Percent Change From Baseline in GAF Score |
17.2; 11.1; 20.7; 18.5; 34.4; 18.8 | — |
| SECONDARY Mean Percent Change From Baseline in Quick Inventory of Depressive Symptoms - Self Report (QIDS-SR) Score |
-0.6; -2.8; -10.4; -2.3; -41.1; -21.0 | — |
| SECONDARY Mean Percent Change From Baseline in Clinical Global Impression of Severity and Improvement (CGI) Severity of Illness |
-3.5; -6.7; -12.6; -12.7; -33.6; -8.7 | — |
| SECONDARY Mean Total CGI for Global Improvement Score |
4.0; 4.0; 3.6; 3.3; 2.3; 3.0 | — |
| SECONDARY Mean Percent Change From Baseline in Patient Global Impression Index (PGI) Severity of Illness |
11.7; -4.8; 12.0; 20.0; -26.1; 26.2 | — |
| SECONDARY Mean Total PGI for Global Improvement Score |
4.2; 4.3; 4.0; 4.0; 2.3; 4.0 | — |
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.
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 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;
Data sourced from ClinicalTrials.gov (NCT01331330). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.