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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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The objective of this investigation is to examine the safety and feasibility of a series of repetitive transcranial magnetic stimulation (rTMS) treatments (10 Hertz [Hz]; Left Dorsolateral Prefrontal Cortex), with a Neuronetics Model 2100 Therapy System as adjuvant treatment for depression in adolescent subjects.
High frequency rTMS applied to the left dorsolateral prefrontal cortex (L-DLPFC) has been shown to have an antidepressant effect. Initial studies comparing electroconvulsive therapy (ECT) and rTMS suggest that rTMS has been as effective as ECT in treating non-psychotic depression. Given the high degree of ongoing dysfunction in depressed adolescents despite optimization of treatment with antidepressant medications, new concerns regarding suicidal thoughts and behaviors in adolescents treated with antidepressant medications, and the more interventional nature of ECT, the use of rTMS as adjuvant therapy may be of significant clinical benefit. Thus far, research using rTMS to treat depression in adolescents has been limited. The primary aim of this study is to examine the safety and feasibility of using 10 Hz rTMS applied to the left dorsolateral prefrontal cortex (L-DLPFC) as adjuvant treatment for depression in adolescents.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rTMS Treatment | Experimental | All subjects will have active rTMS treatment (10Hz, L-DLPFC - 3,000 Stimulations/treatment) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rTMS Treatment | Device | Active rTMS treatment. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cognitive Status as Measured by the Children's Auditory Verbal Learning Test 2 (CAVLT-2) | The Children's Auditory Verbal Learning Test 2 (CAVLT-2) is a neuropsychological test that measures auditory verbal learning and memory. This test is designed for ages 6.6-17.11 years. Scores are reported as normalized standard scores. The minimum standard score is 60 and the maximum 140; a higher score indicates a better performance. | Pre-treatment (baseline visit) and post treatment (approximately 6-8 weeks after baseline visit) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Level of Depression at Visit 30, as Measured by the Children's Depression Rating Scale, Revised (CDRS-R) | The Children's Depression Rating Scale, Revised (CDRS-R) is a validated, 17-item, clinician rating tool to assess severity of depression. Parents provide input into 14 of the items. Scores range from 0 to 60, with the following scale: not depressed (<20), borderline depressive symptoms (20-29), mild depression (30-39), moderate depression (40-59), severe depression (>/=60). |
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Inclusion Criteria:
Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnosis of unipolar major depression without psychosis.
Current or past history of lack of response to at least two adequate antidepressant trials selective serotonin re-uptake inhibitors (SSRI) operationally defined using the Antidepressant Treatment History Form (ATHF)
Children's Depression Rating Scale-Revised (CDRS-R) score of 40 or higher at baseline
At least six weeks of ongoing SSRI therapy at a stable dose.
SSRI Medications will include:
Age 13-18 years.
Outpatient, inpatient, or partial hospitalization patients.
Capable of providing informed assent/consent (in addition to parent/guardian consent).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shirlene M. Sampson, M.D. | Mayo Clinic | Principal Investigator |
| Christopher A. Wall, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University | Chicago | Illinois | 60612 | United States | ||
| Mayo Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21951987 | Result | Wall CA, Croarkin PE, Sim LA, Husain MM, Janicak PG, Kozel FA, Emslie GJ, Dowd SM, Sampson SM. Adjunctive use of repetitive transcranial magnetic stimulation in depressed adolescents: a prospective, open pilot study. J Clin Psychiatry. 2011 Sep;72(9):1263-9. doi: 10.4088/JCP.11m07003. | |
| 31634515 | Derived | Sonmez AI, Kucuker MU, Lewis CP, Kolla BP, Doruk Camsari D, Vande Voort JL, Schak KM, Kung S, Croarkin PE. Improvement in hypersomnia with high frequency repetitive transcranial magnetic stimulation in depressed adolescents: Preliminary evidence from an open-label study. Prog Neuropsychopharmacol Biol Psychiatry. 2020 Mar 8;97:109763. doi: 10.1016/j.pnpbp.2019.109763. Epub 2019 Oct 18. |
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Subjects were recruited from clinical and community referrals at 3 participating sites. The study took place from May 2007 to October 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Treatment | All subjects will have active rTMS treatment (10Hz, L-DLPFC - 3,000 Stimulations/treatment) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Treatment | All subjects will have active rTMS treatment (10Hz, L-DLPFC - 3,000 Stimulations/treatment) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Change in Cognitive Status as Measured by the Children's Auditory Verbal Learning Test 2 (CAVLT-2) | The Children's Auditory Verbal Learning Test 2 (CAVLT-2) is a neuropsychological test that measures auditory verbal learning and memory. This test is designed for ages 6.6-17.11 years. Scores are reported as normalized standard scores. The minimum standard score is 60 and the maximum 140; a higher score indicates a better performance. | Posted | Mean | Standard Deviation | units on a scale | Pre-treatment (baseline visit) and post treatment (approximately 6-8 weeks after baseline visit) |
|
Subjects were assessed for safety over the 6-8 weeks of treatment and at the 6- month follow-up assessment.
Subjects were monitored for the possibility of headaches and scalp discomfort with a visual analog scale after each treatment.
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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 | Active Treatment | All subjects will have active rTMS treatment (10Hz, L-DLPFC - 3,000 Stimulations/treatment) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Scalp Discomfort | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Scalp discomfort is an anticipated adverse event associated with rTMS treatment. |
Limitations of the study include its open design, and small number of total participants.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christopher Wall | Mayo Clinic | 5072843352 | wall.chris@mayo.edu |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| At study visit 30 |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| University of Texas Southwestern | Dallas | Texas | 75390 | United States |
| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units |
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| Counts |
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| Participants |
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| Secondary | Mean Level of Depression at Visit 30, as Measured by the Children's Depression Rating Scale, Revised (CDRS-R) | The Children's Depression Rating Scale, Revised (CDRS-R) is a validated, 17-item, clinician rating tool to assess severity of depression. Parents provide input into 14 of the items. Scores range from 0 to 60, with the following scale: not depressed (<20), borderline depressive symptoms (20-29), mild depression (30-39), moderate depression (40-59), severe depression (>/=60). | Posted | Mean | Standard Deviation | units on a scale | At study visit 30 |
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| 0 |
| 8 |
| 3 |
| 8 |
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