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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
9
Normal DBS Programming
Low Programming
CHU Pasteur
Nice, France
Hôpital La Pitié Salpêtrière
Paris, France
Hadassah-Hebrew University Medical Center
Jerusalem, Israel
King's College London
London, United Kingdom
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.
Time frame: 4, 7, 10 and 13 months
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.
Time frame: 4, 7, 10 and 13 month
Responder Rate (40% Reduction in MADRS)
Time frame: 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.
Time frame: 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.
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National Hospital for Neurology and Neurosurgery - UCL
London, United Kingdom
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 4, 7, 10 and 13 months