Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| G080033 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Medtronic, Inc. sponsored an investigational study of the Reclaimâ„¢ Deep Brain Stimulation (DBS) System in people that have treatment-resistant depression. Depression is a mood disorder and a serious medical condition that affects millions of Americans. Depressive symptoms may include loss of interest in things typically enjoyed; decreased energy levels; difficulty concentrating or making decisions; restlessness; and feelings of pessimism, hopelessness, and worthlessness. Treatment-resistant depression is a chronic and severe form of depression characterized by failure to respond to traditional forms of treatment, such as antidepressant medications and electroconvulsive therapy. Treatment-resistant depression significantly impacts quality of life, productivity, and is a major contributor of disability world-wide.
This randomized, double-blind, sham stimulation-controlled, multi-center, prospective, parallel design study used deep brain stimulation technology to test whether active bilateral stimulation can safely and effectively improve depressive symptoms in patients with treatment-resistant depression compared to sham stimulation.
Participants meeting criteria for the study were implanted with the Reclaim DBS System. Participants in the active group, who received active stimulation, were compared to the control group, who received sham stimulation, during the 16-week blinded-treatment phase. All participants were monitored for changes in depressive symptoms. After the blinded-treatment phase, all participants received active stimulation.
Candidates for the trial were adults who had major depressive disorder and had not responded to several treatments for depression. Participants in the study continued to receive their current antidepressant medications while participating in the trial.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Group - Active Stimulation | Active Comparator | Receive active stimulation with Reclaimâ„¢ DBS System |
|
| Control Group - Sham Stimulation | Sham Comparator | Receive sham stimulation with Reclaimâ„¢ DBS System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reclaimâ„¢ DBS System | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Responders | Montgomery-Ã…sberg Depression Rating Scale (MADRS); total score can range from 0 (no symptoms) to 60 (severe depression). Response is defined as at least a 50% improvement (decline) in MADRS score. Responder rate is the proportion of participants who experience response. | Baseline to 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Depression Change | Montgomery-Ã…sberg Depression Rating Scale (MADRS); total score can range from 0 (no symptoms) to 60 (severe depression). Improvement is measured by the groups' mean percent change in MADRS score. An improvement is represented by a decline in MADRS (a negative percent change). | Baseline to 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term Open-label Responders | This measure is for long-term, open-label stimulation. Response is defined as at least a 50% improvement (decline) in MADRS score. Responder rate is the proportion of participants who experience response. All enrolled participants are included in the analysis, even if they withdrew early. Participants that withdrew early are counted as non-responders. | at the 24-month visit |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Charlestown | Massachusetts | 02129 | United States | ||
| Cleveland Clinic Foundation |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25726497 | Result | Dougherty DD, Rezai AR, Carpenter LL, Howland RH, Bhati MT, O'Reardon JP, Eskandar EN, Baltuch GH, Machado AD, Kondziolka D, Cusin C, Evans KC, Price LH, Jacobs K, Pandya M, Denko T, Tyrka AR, Brelje T, Deckersbach T, Kubu C, Malone DA Jr. A Randomized Sham-Controlled Trial of Deep Brain Stimulation of the Ventral Capsule/Ventral Striatum for Chronic Treatment-Resistant Depression. Biol Psychiatry. 2015 Aug 15;78(4):240-8. doi: 10.1016/j.biopsych.2014.11.023. Epub 2014 Dec 13. | |
| 34670028 |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Active Group-Active Stimulation | Receive active stimulation during the first 16 weeks after device implant. |
| FG001 | Control Group-Sham Stimulation | Receive sham stimulation during the first 16 weeks after device implant. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Blinded-treatment Phase |
|
| ||||||||||||||||||
| Long-term Follow-up Phase - Open Label |
|
All enrolled participants are included.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Active Group-Active Stimulation | Receive active stimulation during the first 16 weeks after device implant. |
| BG001 | Control Group-Sham Stimulation | Receive sham stimulation during the first 16 weeks after device implant. |
| 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 | Responders | Montgomery-Ã…sberg Depression Rating Scale (MADRS); total score can range from 0 (no symptoms) to 60 (severe depression). Response is defined as at least a 50% improvement (decline) in MADRS score. Responder rate is the proportion of participants who experience response. | 29 of the 30 subjects are included in this analysis. One active group subject did not receive the allocated treatment, and is not included in the primary and secondary efficacy outcome analyses. | Posted | Number | participants | Baseline to 16 weeks |
|
16 weeks
Adverse event results for the blinded-treatment phase only. All randomized subjects were included in adverse event summaries.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Group-Active Stimulation | Receive active stimulation during the first 16 weeks after device implant. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depression | Psychiatric disorders | MedDRA (8.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Implant site pain | General disorders | MedDRA (8.0) | Systematic Assessment |
With this 30-subject cohort, and only 29 subjects completing the blinded-treatment phase per protocol, the comparisons of response rates and improvements were not adequately powered.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eric Williamson, Clinical Evidence Specialist | Medtronic Neuromodulation | 763-526-7982 | medtronicneurotrials@medtronic.com |
Not provided
| ID | Term |
|---|---|
| D003863 | Depression |
| D061218 | Depressive Disorder, Treatment-Resistant |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Quality of Life Change |
Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF); total score can range from 0 to 100 with higher scores indicating a better quality of life. Improvement is measured by the groups' mean change in Q-LES-Q-SF score. An improvement is represented by an increase in Q-LES-Q-SF (a positive change). |
| Baseline to 16 weeks |
| Therapy-related Adverse Events | Adverse events related to the device, implant procedure, and/or stimulation are reported. Events with a prevalence of greater than 5% of subjects are reported. This measure describes the experience of all study participants (both Active and Control Groups combined), and includes the operative, blinded-treatment,and the long-term open-label follow-up phases combined. Active Group participants began therapy after randomization, while Control Group participants began therapy after 16 weeks of sham stimulation. | from enrollment to study closure (average follow-up of 36 months) |
| Cleveland |
| Ohio |
| 44195 |
| United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Butler Hospital | Providence | Rhode Island | 02906 | United States |
| Derived |
| Giacomo ED, Placenti V, Colmegna F, Clerici M. Obsessive-Compulsive Disorder in Pregnancy and Postpartum: The Possible Etiologic Role and Implications of Obsessive-Compulsive Personality Disorder. J Clin Psychiatry. 2021 Oct 19;82(6):21lr14069. doi: 10.4088/JCP.21lr14069. No abstract available. |
| 34670027 | Derived | Fairbrother N, Collardeau F. High Prevalence of Perinatal-Occurring Obsessive-Compulsive Disorder: Reply to Di Giacomo et al. J Clin Psychiatry. 2021 Oct 19;82(6):21lr14069a. doi: 10.4088/JCP.21lr14069a. No abstract available. |
| 34670026 | Derived | Hitti FL, Cristancho MA, Yang AI, O'Reardon JP, Bhati MT, Baltuch GH. Deep Brain Stimulation of the Ventral Capsule/Ventral Striatum for Treatment-Resistant Depression: A Decade of Clinical Follow-Up. J Clin Psychiatry. 2021 Oct 19;82(6):21m13973. doi: 10.4088/JCP.21m13973. |
| 27659923 | Derived | Kubu CS, Brelje T, Butters MA, Deckersbach T, Malloy P, Moberg P, Troster AI, Williamson E, Baltuch GH, Bhati MT, Carpenter LL, Dougherty DD, Howland RH, Rezai AR, Malone DA Jr. Cognitive outcome after ventral capsule/ventral striatum stimulation for treatment-resistant major depression. J Neurol Neurosurg Psychiatry. 2017 Mar;88(3):262-265. doi: 10.1136/jnnp-2016-313803. Epub 2016 Sep 22. |
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Baseline depression score | Montgomery-Ã…sberg Depression Rating Scale (MADRS); total score can range from 0 (no symptoms) to 60 (severe depression) | Mean | Standard Deviation | units on a scale |
|
Receive sham stimulation during the first 16 weeks after device implant. |
|
|
|
| Secondary | Depression Change | Montgomery-Ã…sberg Depression Rating Scale (MADRS); total score can range from 0 (no symptoms) to 60 (severe depression). Improvement is measured by the groups' mean percent change in MADRS score. An improvement is represented by a decline in MADRS (a negative percent change). | One active group subject did not receive the allocated treatment, and is not included in the primary and secondary efficacy outcome analyses. | Posted | Mean | Standard Deviation | percentage change from baseline | Baseline to 16 weeks |
|
|
|
| Secondary | Quality of Life Change | Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF); total score can range from 0 to 100 with higher scores indicating a better quality of life. Improvement is measured by the groups' mean change in Q-LES-Q-SF score. An improvement is represented by an increase in Q-LES-Q-SF (a positive change). | One active group subject did not receive the allocated treatment, and is not included in the primary and secondary efficacy outcome analyses. | Posted | Mean | Standard Deviation | change from baseline score | Baseline to 16 weeks |
|
|
|
| Other Pre-specified | Long-term Open-label Responders | This measure is for long-term, open-label stimulation. Response is defined as at least a 50% improvement (decline) in MADRS score. Responder rate is the proportion of participants who experience response. All enrolled participants are included in the analysis, even if they withdrew early. Participants that withdrew early are counted as non-responders. | 29 participants started the the Long-Term Follow-up Phase and 24 completed the phase, but all 30 enrolled participants are included in the analysis. Participants that withdrew early are counted as non-responders. | Posted | Number | participants | at the 24-month visit |
|
|
|
| Other Pre-specified | Therapy-related Adverse Events | Adverse events related to the device, implant procedure, and/or stimulation are reported. Events with a prevalence of greater than 5% of subjects are reported. This measure describes the experience of all study participants (both Active and Control Groups combined), and includes the operative, blinded-treatment,and the long-term open-label follow-up phases combined. Active Group participants began therapy after randomization, while Control Group participants began therapy after 16 weeks of sham stimulation. | All enrolled participants are included in the analysis. | Posted | Number | participants | from enrollment to study closure (average follow-up of 36 months) |
|
|
|
| 4 |
| 16 |
| 15 |
| 16 |
| EG001 | Control Group-Sham Stimulation | Receive sham stimulation during the first 16 weeks after device implant. | 4 | 14 | 14 | 14 |
| Suicidal ideation | Psychiatric disorders | MedDRA (8.0) | Systematic Assessment |
|
| Disinhibition | Psychiatric disorders | MedDRA (8.0) | Systematic Assessment |
|
| Femoral arterial stenosis | Vascular disorders | MedDRA (8.0) | Systematic Assessment |
|
| Wound infection staphylococcal | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
|
| Neurostimulator protrusion | Injury, poisoning and procedural complications | MedDRA (8.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (8.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (8.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (8.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (8.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (8.0) | Systematic Assessment |
|
| Irritability | Psychiatric disorders | MedDRA (8.0) | Systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA (8.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (8.0) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
|
| Disinhibition | Psychiatric disorders | MedDRA (8.0) | Systematic Assessment |
|
| Hypomania | Psychiatric disorders | MedDRA (8.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
|
| Drug withdrawal syndrome | General disorders | MedDRA (8.0) | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA (8.0) | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA (8.0) | Systematic Assessment |
|
| Localised infection | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
|
| Adnexa uteri mass | Reproductive system and breast disorders | MedDRA (8.0) | Systematic Assessment |
|
| Bunion | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | Systematic Assessment |
|
| Cognitive disorder | Nervous system disorders | MedDRA (8.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
|
| Energy increased | General disorders | MedDRA (8.0) | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA (8.0) | Systematic Assessment |
|
| Hypersomnia | Nervous system disorders | MedDRA (8.0) | Systematic Assessment |
|
| Hyporeflexia | Nervous system disorders | MedDRA (8.0) | Systematic Assessment |
|
| Mania | Psychiatric disorders | MedDRA (8.0) | Systematic Assessment |
|
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.0) | Systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA (8.0) | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (8.0) | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA (8.0) | Systematic Assessment |
|
| Allodynia | General disorders | MedDRA (8.0) | Systematic Assessment |
|
| Animal bite | Injury, poisoning and procedural complications | MedDRA (8.0) | Systematic Assessment |
|
| Back injury | Injury, poisoning and procedural complications | MedDRA (8.0) | Systematic Assessment |
|
| Balance disorder | Nervous system disorders | MedDRA (8.0) | Systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
|
| Early morning awakening | Psychiatric disorders | MedDRA (8.0) | Systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
|
| Menstruation irregular | Reproductive system and breast disorders | MedDRA (8.0) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (8.0) | Systematic Assessment |
|
| Purging | Psychiatric disorders | MedDRA (8.0) | Systematic Assessment |
|
| Restless legs syndrome | Nervous system disorders | MedDRA (8.0) | Systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA (8.0) | Systematic Assessment |
|
| Upper respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Systematic Assessment |
|
The disclosure restrictions on the PI allow for the sponsor to review results communications prior to public release and to embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to sponsor for review. The sponsor is also allowed to require changes for technical correctness and to protect confidential information, copyrightable or patentable material; and when reasonably requested, extend the embargo up to an additional 90 days.
| D001523 |
| Mental Disorders |
| Title | Measurements |
|---|---|
|
| Procedure - Implant site infection |
|
| Procedure - Dermatitis contact |
|
| Procedure - Face oedema |
|
| Procedure - Headache |
|
| Procedure - Hypersensitivity |
|
| Stimulation - Insomnia |
|
| Stimulation - Depression |
|
| Stimulation - Hypomania |
|
| Stimulation - Irritability |
|
| Stimulation - Anxiety |
|
| Stimulation - Fatigue |
|
| Stimulation - Headache |
|
| Stimulation - Agitation |
|
| Stimulation - Sleep disorder |
|
| Stimulation - Disturbance in attention |
|
| Stimulation - Suicidal ideation |
|
| Stimulation - Disinhibition |
|
| Stimulation - Memory impairment |
|
| Stimulation - Paraesthesia |
|
| Stimulation - Energy increased |
|
| Stimulation - Impulsive behaviour |
|
| Stimulation - Nausea |
|
| Stimulation - Thinking abnormal |
|
| Stimulation - Weight increased |
|