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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group B | Active Comparator | Low Programming |
|
| Group A | Experimental | Normal Programming |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep Brain Stimulation | Device | Normal DBS Programming |
| |
| Deep Brain Stimulation |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicole Harbert | Abbott Medical Devices | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Pasteur | Nice | 06002 | France | |||
| Hôpital La Pitié Salpêtrière |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 : High Frequency Group | Group 1 : DBS High Frequency (HF) Group Device Programming (130 Hz) Implanted with investigational device and activated for stimulation. |
| FG001 | Group 2 : Low Frequency Group | Group 2 : DBS Low Frequency (LF) Group Device Programming (20 Hz) Implanted with investigational device and activated for stimulation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 : High Frequency Group | Group 1 : DBS High Frequency (HF) Group Device Programming (130 Hz) Implanted with investigational device and activated for stimulation. |
| BG001 | Group 2 : Low Frequency Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The number of participants analyzed includes subjects who were available at that time of analysis. | Posted | Mean | Standard Deviation | percentage change from baseline | 4, 7, 10 and 13 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 : High Frequency Group | Group 1 : DBS High Frequency (HF) Group Device Programming (130 Hz) Implanted with investigational device and activated for stimulation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Overdose of Diathipin and Valium | Psychiatric disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal upset and tremors | Gastrointestinal disorders | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Devyani Nanduri | Abbott Medical Devices | +1 510-561-4328 | devyani.nanduri@abbott.com |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003866 | Depressive Disorder |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D046690 | Deep Brain Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| Device |
Low Programming |
|
| 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 |
| Paris |
| 75651 |
| France |
| Hadassah-Hebrew University Medical Center | Jerusalem | 91120 | Israel |
| King's College London | London | SE5 9RS | United Kingdom |
| National Hospital for Neurology and Neurosurgery - UCL | London | WC1N 3 | United Kingdom |
Group 2 : DBS Low Frequency (LF) Group Device Programming (20 Hz) Implanted with investigational device and activated for stimulation.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Group 2 : DBS Low Frequency (LF) Group Device Programming (20 Hz) Implanted with investigational device and activated for stimulation.
|
|
| Secondary | 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. | The number of participants analyzed includes subjects who were available at that time of analysis. | Posted | Mean | Standard Deviation | percent change from baseline | 4, 7, 10 and 13 month |
|
|
|
| Secondary | Responder Rate (40% Reduction in MADRS) | The number of participants analyzed includes subjects who were available at that time of analysis. | Posted | Count of Participants | Participants | 4, 7, 10 and 13 months |
|
|
|
| Secondary | 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. | The number of participants analyzed includes subjects who were available at that time of analysis. | Posted | Mean | Standard Deviation | percentage change from baseline | 4, 7, 10 and 13 months |
|
|
|
| Secondary | 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. | The number of participants analyzed includes subjects who were available at that time of analysis. | Posted | Mean | Standard Deviation | percentage change from baseline | 4, 7, 10 and 13 months |
|
|
|
| Secondary | 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. | The number of participants analyzed includes subjects who were available at that time of analysis. | Posted | Mean | Standard Deviation | percentage change from baseline | 4, 7, 10 and 13 months |
|
|
|
| Secondary | 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. | The number of participants analyzed includes subjects who were available at that time of analysis. | Posted | Mean | Standard Deviation | percentage change from baseline | 4, 7, 10 and 13 months |
|
|
|
| Secondary | 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. | The number of participants analyzed includes subjects who were available at that time of analysis. | Posted | Mean | Standard Deviation | scores on a scale | 4, 7, 10 and 13 months |
|
|
|
| Secondary | 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. | The number of participants analyzed includes subjects who were available at that time of analysis. | Posted | Mean | Standard Deviation | percentage change from baseline | 4, 7, 10 and 13 months |
|
|
|
| Secondary | 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. | The number of participants analyzed includes subjects who were available at that time of analysis. | Posted | Mean | Standard Deviation | scores on a scale | 4, 7, 10 and 13 months |
|
|
|
| 0 |
| 5 |
| 1 |
| 5 |
| 4 |
| 5 |
| EG001 | Group 2 : Low Frequency Group | Group 2 : DBS Low Frequency (LF) Group Device Programming (, 20 Hz)) Implanted with investigational device and activated for stimulation. | 0 | 4 | 0 | 4 | 4 | 4 |
| Abdominal upset, hyperacidity and diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea and vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Dental abscess (lower jaw on the left side) | General disorders | Systematic Assessment |
|
| Dizziness and losing balance (otitis media) | General disorders | Systematic Assessment |
|
| Episode of anxiety | General disorders | Systematic Assessment |
|
| Facial pain | General disorders | Systematic Assessment |
|
| First of 2 falls | General disorders | Systematic Assessment |
|
| Frontal headache on the left side | General disorders | Systematic Assessment |
|
| Itching at the front hairline | General disorders | Systematic Assessment |
|
| Itching of the scalp, when the head bandage was on | General disorders | Systematic Assessment |
|
| Itchy scalp | General disorders | Systematic Assessment |
|
| Losing balance | General disorders | Systematic Assessment |
|
| Poor memory to recent events | General disorders | Systematic Assessment |
|
| Scalp itching under the head bandage | General disorders | Systematic Assessment |
|
| Second of 2 falls | General disorders | Systematic Assessment |
|
| Sensation (tingling) in different parts of the face on touching the scalp | General disorders | Systematic Assessment |
|
| Sore throat, fever, lethargy, drowsiness | General disorders | Systematic Assessment |
|
| Tightness in the neck | General disorders | Systematic Assessment |
|
| Blood oozing (bleeding) from the incision on the left side of the scalp | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Burning sensation over the chest scar | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Itching and pain at the site of the surgical incision in the chest on moving the left arm | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Mild headache at the site of the incisions in the scalp | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Mild pain and tenderness at left upper side of the chest (battery site) | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Pain (neuralgia) over the left tempromadipular joint and extended to left scalp | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Pain and tenderness at the site of the chest incision | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Post operative headache | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Post surgical headache (mainly in the forehead, throbbing in nature) | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Redness and mild swelling at the site of the left scalp incision and chest incision | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Redness and swelling at the site of the chest incision | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Stabbing pain at the site of the chest surgical incision | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Tenderness at the left side of the scalp when the patient lies down on that side | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Throbbing sensation at the site of the right scalp incision | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Aching pain over the middle 3 fingers and palm of the right hand | Nervous system disorders | Systematic Assessment |
|
| Vibration at the top left end of the ipg | Product Issues | Systematic Assessment |
|
| Pollakiury | Renal and urinary disorders | Systematic Assessment |
|
| Esophageal irritation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Sore throat (upper respiratory tract infection) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| 7 months |
|
|
| 10 months |
|
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| 13 months |
|
|
| 7 months |
|
|
| 10 months |
|
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| 13 months |
|
|
| 10 months |
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| 13 months |
|
| 10 months |
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| 13 months |
|
| 10 months |
|
| 13 months |
|
| 10 months |
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| 13 months |
|
| 10 months |
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| 13 months |
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| 10 months |
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| 13 months |
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| 10 months |
|
| 13 months |
|