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This study will be an open-label 6-week (30 session) trial of active repetitive transcranial magnetic stimulation (rTMS) using a fixed frequency (10 Hz) but varying stimulation intensities using a 3+3 study design for safety and tolerability amongst adolescents. This means that we will only enroll 3 participants at a time and give them rTMS at the stimulation intensity energy of 80% of motor threshold (MT). If all three participants complete the 6 weeks of treatment with no major safety events (i.e. seizure), we will increase the energy for the next 3 participants by 20%. If 1 of the 3 participants has a major safety event, we will enroll 3 more patients at the SAME energy. We will proceed in this manner, increasing by 20% after 3 subjects safely complete treatment at that energy, to a maximum energy of 120% of motor threshold. If 2 participants in each intensity level cohort experience a major safety event, we will discontinue running subjects at that energy level. If this happens at our initial energy level of 80% of MT, we will stop the study. If we reach 2 events in any of the higher energy cohorts, we will return to the previous energy level and complete the remainder of the subjects at that energy level.
Adolescents with Treatment Resistant Depression (TRD) (n=30) will be recruited from the inpatient and outpatient adolescent mental health clinical services at UMN and surrounding area.
Adolescents and parents will undergo the consent process and initial clinical evaluation. This initial evaluation will be done using the Kiddie Schedule of Affective Disorders and Schizophrenia (K-SADS-PL 2009) and the Children's Depression Rating Scale-Revised (CDRS-R). Participants and their families will also be asked to complete the Antidepressant Treatment Report (ATR), Beck Depression Inventory (BDI-II), Columbia Suicide Severity Rating Scale (C-SSRS), Inventory of Depression and Anxiety Symptoms (IDAS), Temporal Experience of Pleasure Scale (TEPS), Snaith-Hamilton Pleasure Scale (SHAPS), Young Mania Rating Scale (YMRS), Edinburgh Handedness Scale, the Weschler Abbreviated Scale of Intelligence (WASI) and the Tanner Pubertal Staging Questionnaire. Participants will also be asked to complete the NIH Toolbox, Children's Auditory Verbal Learning Test (CAVLT), and the Delis-Kaplan Executive Function System (D-KEFS) Trail Making Test.
Adolescents with TRD who fit inclusion/exclusion criteria (presence of major depression with CDRS-R raw score > 40; a history of at least one failed treatment trial with an antidepressant [as defined by the Antidepressant Treatment Report]; no history of seizure disorder; no presence of MRI contraindications [e.g. claustrophobia or metallic implants]) will be scheduled for:
A. A baseline MRI (described below)
B. 6 weeks of the series of rTMS visits described below
C. A post-treatment MRI
D. A post-treatment clinical assessment (blinded to treatment assignment)
E. 6 monthly follow up visits
In the first rTMS visit, the study physician will fit the cap, determine the ideal location for stimulation, and measure MT and MEPa. Adolescents will receive 6 weeks of rTMS, 20 minutes/day, 5 days/week administered by a trained technician. Active treatment will be 43 trains of 10 Hz, stimulation intensity will vary as described above, inter-train interval 20 seconds, 1680 pulses/session. A member of research staff will meet weekly with patients to complete the CDRS-R, monitor treatment tolerance using the Side Effects Form for Children and Adolescents, and measure the MT and MEPa. Adolescents will also complete the BDI-II, C-SSRS-SLV, IDAS, TEPS, YMRS, and SHAPS weekly. At week four, the participants will be asked to repeat the NIH Toolbox, Children's Auditory Verbal Learning Test (CAVLT), and the Delis-Kaplan Executive Function System (D-KEFS) Trail Making Test.
Scanning will take place at the Center for Magnetic Resonance Research on a 3T Siemens Prisma scanner at baseline (after the clinical assessment, before the first treatment) and after the last rTMS treatment. Participants will complete MRI safety forms and provide a urine sample to rule out substance use (all participants) and pregnancy (females only). A high-resolution T1 image will be collected (voxel size=1mm isotropic; TR=2530ms; TE=3.65ms, T1=1100ms, flip angle=7°, 5 minutes). Functional data will be acquired using the Human Connectome Project (HCP)38 multiband echo planar imaging sequence (whole brain T2*-weighted functional volumes, 72 contiguous slices; TR=720ms; TE=34.2ms; flip angle=55o, FOV=212mm; voxel size=2mm isotropic; matrix=106x106; multiband factor=8; 12 minutes) during rest with eyes open while viewing a fixation cross.
Participants will be asked to complete a task fMRI in which they are presented with a series of visual stimuli, (human faces of varying emotion expressions with positive, negative or neutral words printed over the faces). During the task, participants will be asked to decide whether the words printed over the faces are positive or negative regardless of the emotion of the face shown. Each subject will complete four distinct blocks of the task.
After the completion of rTMS sessions, all participants will undergo a final assessment during which they will be asked to meet with evaluators again to complete the CDRS-R. They will also be asked to complete the BDI-II, C-SSRS, TEPS, SHAPS, IDAS and NIH Toolbox.
After the completion of all rTMS sessions, participants will be asked to return to see researchers every month for 6 months to assess length of treatment response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1: 80% of MT | Experimental | All participants who qualify will undergo 6 weeks of open-label rTMS with a stimulation intensity of 80% of MT |
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| Period 2: 100% of MT | Experimental | All participants who qualify will undergo 6 weeks of open-label rTMS with a stimulation intensity of 100% of MT |
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| Period 3: 120% of MT | Experimental | All participants who qualify will undergo 6 weeks of open-label rTMS with a stimulation intensity of 120% of MT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Repetitive Transcranial Magnetic Stimulation (rTMS): intensity 80% MT | Device | rTMS applies a pulsatile magnetic field to the scalp which painlessly induces electrical currents to the brain. Typically, rTMS is applied to the dorsolateral prefrontal cortex (DLPFC), a brain region that is hypoactive in depression. Whereas standard rTMS stimulates superficial (1cm depth) cortical areas, recent advances in rTMS coil technology support stimulation of deeper (5 cm depth) limbic structures that are also relevant to depression. Other Name: Brainsway rTMS |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Score on Child Depression Rating Scale - Revised (CDRS-R) | The Children's Depression Rating Scale-Revised (CDRS-R) is a measure of depression severity in adolescents and children of ages 6 to 12. The measure is completed by a clinician based on interviews with the child/adolescent and their parent. The scale includes 17 symptom areas, each rated on a likert scale ranging from 1 to 5 or 7. Depression severity is indiciated by the CDRS-R raw summary score computed by adding the item responses. The summary score ranges from 17 to 113, with a higher score indicating more severe depression and worse outcome. Change in score for each participant was calculated by subtracting their post-rTMS score from their baseline score, such that a positive value indicates a decrease in score from pre to post-treatment. | Baseline to post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Score Beck Depression Inventory (BDI-II) | The Beck Depression Inventory (BDI-II) is a 21-item self-report measure of depression severity in adolescents and adults. Each item is measured on a likert scale ranging from 0 to 3. A total score is calculated by adding item responses and can range from 0 to 63, with a higher score indicating more severe depression and worse outcome. Change in score for each participant was calculated by subtracting their post-rTMS score from their baseline score, such that a positive value indicates a decrease in score from pre to post-treatment. |
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Inclusion Criteria:
Exclusion Criteria:
(*) If the participant has an insufficient number of trials in the current episode, then the participant must also have failed ≥1 and ≤4 trials in a previous episode. Subjects who have been unable to complete an antidepressant trial of adequate dose and duration due to intolerance to antidepressant therapy may be included if they have demonstrated intolerance to ≥4 antidepressant medications within one discrete illness episode (current or previous episode as defined above)
(**) If there has been a recent discontinuation of a medication we will require varying lapses of time before study entry depending on medication type as follows: Antidepressant medications = 4 weeks, mood stabilizers (e.g. Lithium, Valproate) = 2 weeks, Antipsychotic medications = 2 weeks, Stimulant medications = 1 week
(***) If participants are being treated with stimulant medications as an adjunct strategy for their depression, we will require them to discontinue the stimulant prior to starting the study treatment and wait 1 week before they begin the study as listed above. If the participant is taking a stimulant medication to treat ADHD, they will be allowed to continue the stimulant medication, as long as the dosage is within FDA recommendations.
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| Name | Affiliation | Role |
|---|---|---|
| Kathryn R Cullen, MD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55454 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27447245 | Derived | Cullen KR, Jasberg S, Nelson B, Klimes-Dougan B, Lim KO, Croarkin PE. Seizure Induced by Deep Transcranial Magnetic Stimulation in an Adolescent with Depression. J Child Adolesc Psychopharmacol. 2016 Sep;26(7):637-41. doi: 10.1089/cap.2016.0070. Epub 2016 Jul 22. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Period 1: 80% of MT | All participants who qualify will undergo 6 weeks of open-label rTMS with a stimulation intensity of 80% of MT |
| FG001 | Period 2: 100% of MT | All participants who qualify will undergo 6 weeks of open-label rTMS with a stimulation intensity of 100% of MT |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 17, 2021 |
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| Device: Active Repetitive Transcranial Magnetic Stimulation (rTMS); Stimulation intesity: 100% of MT | Device | rTMS applies a pulsatile magnetic field to the scalp which painlessly induces electrical currents to the brain. Typically, rTMS is applied to the dorsolateral prefrontal cortex (DLPFC), a brain region that is hypoactive in depression. Whereas standard rTMS stimulates superficial (1cm depth) cortical areas, recent advances in rTMS coil technology support stimulation of deeper (5 cm depth) limbic structures that are also relevant to depression. Other Name: Brainsway rTMS |
|
| Device: Active Repetitive Transcranial Magnetic Stimulation (rTMS); Stimulation intesity: 120% of MT | Device | rTMS applies a pulsatile magnetic field to the scalp which painlessly induces electrical currents to the brain. Typically, rTMS is applied to the dorsolateral prefrontal cortex (DLPFC), a brain region that is hypoactive in depression. Whereas standard rTMS stimulates superficial (1cm depth) cortical areas, recent advances in rTMS coil technology support stimulation of deeper (5 cm depth) limbic structures that are also relevant to depression. Other Name: Brainsway rTMS |
|
| Baseline to post-treatment |
| Change is Score Columbia Suicide Severity Rating Scale (C-SSRS) | Columbia Suicide Severity Rating Scale (C-SSRS- recent version) is a 10-item measure of suicidal ideation and behavior. Participants were assigned a score between 0 and 8, with higher scores indicating the endorsement of more severe suicidal ideation or behavior (a worse outcome) and a score of "0" indicating no suicidal ideation or behavior (better outcome). Change in score for each participant was calculated by subtracting their post-rTMS score from their baseline score, such that a positive value indicates a decrease in score from pre to post-treatment. | Baseline to post-treatment |
| Change in Score Temporal Experience of Pleasure Scale (TEPS) | The Temporal Experience of Pleasure Scale (TEPS) is an 18-item self-report measure of the tendency to anticipate and experience pleasure. Each item is rated on a likert scale ranging from 1 (very false for me) to 6 (very true for me). A total score is calculated by adding item responses and ranges from 18 to 108, such that higher scores indicate greater anticipation and experience of pleasure and better outcome. Change in score for each participant was calculated by subtracting their post-rTMS score from their baseline score, such that a positive value indicates a decrease in score from pre to post-treatment. | Baseline to post-treatment |
| Change in Score Inventory of Depression and Anxiety Symptoms (IDAS) Subscale: General Depression | 64-item measure of mood and anxiety disorder symptoms. Each item is rated on a likert scale ranging from 1 (not at all) to 5 (extremely). The measure includes 2 broad subscales of general depresson (20 items; score range: 20-100) and dysphoria (10 items; score range: 10-50) as well as 10 specific symptom scales: Lassitude (6 items; score range: 6-30), Insomnia (6 items; score range: 6-30), Suicidality (6 items; score range: 6-30), Well-Being (8 items; score range: 8-40), Social Anxiety (5 items; score range: 5-25), Appetite Loss (3 items; score range: 3-15), Appetite Gain (3 items; score range: 3-15), Ill Temper (5 items; score range: 5-25), Panic (8 items; score range: 8-40), and Traumatic Intrusions (4 items; score range: 4-20). Subscale scores are calculated by adding responses for items corresponding to the subscale, with higher scores on each subscale except the well-being subscale indicating poorer outcomes. Higher scores on well-being subscale indicates better outcome. | Baseline to post-treatment |
| Change in Score Young Mania Rating Scale | The Young Mania Rating Scale is a 11-item measure of manic symptoms. Some items are rated on a likert scale ranging from 0 to 4 and some items are rated on a scale ranging from 0 to 8. Total scores range from 0 to 60, with a higher score indiciating higher levels of mania and worse outcome. Change in score for each participant was calculated by subtracting their post-rTMS score from their baseline score, such that a positive value indicates a decrease in score from pre to post-treatment. | Baseline to post-treatment |
| Change in Score Inventory of Depression and Anxiety Symptoms (IDAS) Subscale: Dysphoria | The Inventory of Depression and Anxiety Symptoms (IDAS) is a 64-item measure of mood and anxiety disorder symptoms. Each item is rated on a likert scale ranging from 1 (not at all) to 5 (extremely). The measure includes 2 broad subscales of general depresson (20 items; score range: 20-100) and dysphoria (10 items; score range: 10-50) as well as 10 specific symptom scales: Lassitude (6 items; score range: 6-30), Insomnia (6 items; score range: 6-30), Suicidality (6 items; score range: 6-30), Well-Being (8 items; score range: 8-40), Social Anxiety (5 items; score range: 5-25), Appetite Loss (3 items; score range: 3-15), Appetite Gain (3 items; score range: 3-15), Ill Temper (5 items; score range: 5-25), Panic (8 items; score range: 8-40), and Traumatic Intrusions (4 items; score range: 4-20). Higher scores on each subscale except the well-being subscale indicating poorer outcomes. Higher scores on well-being subscale indicates better outcome. | Baseline to post-rTMS |
| Change in Score Inventory of Depression and Anxiety Symptoms (IDAS) Subscale: Lassitude | The Inventory of Depression and Anxiety Symptoms (IDAS) is a 64-item measure of mood and anxiety disorder symptoms. Each item is rated on a likert scale ranging from 1 (not at all) to 5 (extremely). The measure includes 2 broad subscales of general depresson (20 items; score range: 20-100) and dysphoria (10 items; score range: 10-50) as well as 10 specific symptom scales: Lassitude (6 items; score range: 6-30), Insomnia (6 items; score range: 6-30), Suicidality (6 items; score range: 6-30), Well-Being (8 items; score range: 8-40), Social Anxiety (5 items; score range: 5-25), Appetite Loss (3 items; score range: 3-15), Appetite Gain (3 items; score range: 3-15), Ill Temper (5 items; score range: 5-25), Panic (8 items; score range: 8-40), and Traumatic Intrusions (4 items; score range: 4-20). Higher scores on each subscale except the well-being subscale indicating poorer outcomes. Higher scores on well-being subscale indicates better outcome. | Baseline to post-rTMS |
| Change in Score Inventory of Depression and Anxiety Symptoms (IDAS) Subscale: Insomnia | The Inventory of Depression and Anxiety Symptoms (IDAS) is a 64-item measure of mood and anxiety disorder symptoms. Each item is rated on a likert scale ranging from 1 (not at all) to 5 (extremely). The measure includes 2 broad subscales of general depresson (20 items; score range: 20-100) and dysphoria (10 items; score range: 10-50) as well as 10 specific symptom scales: Lassitude (6 items; score range: 6-30), Insomnia (6 items; score range: 6-30), Suicidality (6 items; score range: 6-30), Well-Being (8 items; score range: 8-40), Social Anxiety (5 items; score range: 5-25), Appetite Loss (3 items; score range: 3-15), Appetite Gain (3 items; score range: 3-15), Ill Temper (5 items; score range: 5-25), Panic (8 items; score range: 8-40), and Traumatic Intrusions (4 items; score range: 4-20). Higher scores on each subscale except the well-being subscale indicating poorer outcomes. Higher scores on well-being subscale indicates better outcome. | Baseline to post-rTMS |
| Change in Score Inventory of Depression and Anxiety Symptoms (IDAS) Subscale: Suicidality | The Inventory of Depression and Anxiety Symptoms (IDAS) is a 64-item measure of mood and anxiety disorder symptoms. Each item is rated on a likert scale ranging from 1 (not at all) to 5 (extremely). The measure includes 2 broad subscales of general depresson (20 items; score range: 20-100) and dysphoria (10 items; score range: 10-50) as well as 10 specific symptom scales: Lassitude (6 items; score range: 6-30), Insomnia (6 items; score range: 6-30), Suicidality (6 items; score range: 6-30), Well-Being (8 items; score range: 8-40), Social Anxiety (5 items; score range: 5-25), Appetite Loss (3 items; score range: 3-15), Appetite Gain (3 items; score range: 3-15), Ill Temper (5 items; score range: 5-25), Panic (8 items; score range: 8-40), and Traumatic Intrusions (4 items; score range: 4-20). Higher scores on each subscale except the well-being subscale indicating poorer outcomes. Higher scores on well-being subscale indicates better outcome. | Baseline to post-rTMS |
| Change in Score Inventory of Depression and Anxiety Symptoms (IDAS) Subscale: Appetite Loss | The Inventory of Depression and Anxiety Symptoms (IDAS) is a 64-item measure of mood and anxiety disorder symptoms. Each item is rated on a likert scale ranging from 1 (not at all) to 5 (extremely). The measure includes 2 broad subscales of general depresson (20 items; score range: 20-100) and dysphoria (10 items; score range: 10-50) as well as 10 specific symptom scales: Lassitude (6 items; score range: 6-30), Insomnia (6 items; score range: 6-30), Suicidality (6 items; score range: 6-30), Well-Being (8 items; score range: 8-40), Social Anxiety (5 items; score range: 5-25), Appetite Loss (3 items; score range: 3-15), Appetite Gain (3 items; score range: 3-15), Ill Temper (5 items; score range: 5-25), Panic (8 items; score range: 8-40), and Traumatic Intrusions (4 items; score range: 4-20). Higher scores on each subscale except the well-being subscale indicating poorer outcomes. Higher scores on well-being subscale indicates better outcome. | Baseline to post-rTMS |
| Change in Score Inventory of Depression and Anxiety Symptoms (IDAS) Subscale: Appetite Gain | The Inventory of Depression and Anxiety Symptoms (IDAS) is a 64-item measure of mood and anxiety disorder symptoms. Each item is rated on a likert scale ranging from 1 (not at all) to 5 (extremely). The measure includes 2 broad subscales of general depresson (20 items; score range: 20-100) and dysphoria (10 items; score range: 10-50) as well as 10 specific symptom scales: Lassitude (6 items; score range: 6-30), Insomnia (6 items; score range: 6-30), Suicidality (6 items; score range: 6-30), Well-Being (8 items; score range: 8-40), Social Anxiety (5 items; score range: 5-25), Appetite Loss (3 items; score range: 3-15), Appetite Gain (3 items; score range: 3-15), Ill Temper (5 items; score range: 5-25), Panic (8 items; score range: 8-40), and Traumatic Intrusions (4 items; score range: 4-20). Higher scores on each subscale except the well-being subscale indicating poorer outcomes. Higher scores on well-being subscale indicates better outcome. | Baseline to post-rTMS |
| Change in Score Inventory of Depression and Anxiety Symptoms (IDAS) Subscale: Ill Temper | The Inventory of Depression and Anxiety Symptoms (IDAS) is a 64-item measure of mood and anxiety disorder symptoms. Each item is rated on a likert scale ranging from 1 (not at all) to 5 (extremely). The measure includes 2 broad subscales of general depresson (20 items; score range: 20-100) and dysphoria (10 items; score range: 10-50) as well as 10 specific symptom scales: Lassitude (6 items; score range: 6-30), Insomnia (6 items; score range: 6-30), Suicidality (6 items; score range: 6-30), Well-Being (8 items; score range: 8-40), Social Anxiety (5 items; score range: 5-25), Appetite Loss (3 items; score range: 3-15), Appetite Gain (3 items; score range: 3-15), Ill Temper (5 items; score range: 5-25), Panic (8 items; score range: 8-40), and Traumatic Intrusions (4 items; score range: 4-20). Higher scores on each subscale except the well-being subscale indicating poorer outcomes. Higher scores on well-being subscale indicates better outcome. | Baseline to post-rTMS |
| Change in Score Inventory of Depression and Anxiety Symptoms (IDAS) Subscale: Well Being | The Inventory of Depression and Anxiety Symptoms (IDAS) is a 64-item measure of mood and anxiety disorder symptoms. Each item is rated on a likert scale ranging from 1 (not at all) to 5 (extremely). The measure includes 2 broad subscales of general depresson (20 items; score range: 20-100) and dysphoria (10 items; score range: 10-50) as well as 10 specific symptom scales: Lassitude (6 items; score range: 6-30), Insomnia (6 items; score range: 6-30), Suicidality (6 items; score range: 6-30), Well-Being (8 items; score range: 8-40), Social Anxiety (5 items; score range: 5-25), Appetite Loss (3 items; score range: 3-15), Appetite Gain (3 items; score range: 3-15), Ill Temper (5 items; score range: 5-25), Panic (8 items; score range: 8-40), and Traumatic Intrusions (4 items; score range: 4-20). Higher scores on each subscale except the well-being subscale indicating poorer outcomes. Higher scores on well-being subscale indicates better outcome. | Baseline to post-rTMS |
| Change in Score Inventory of Depression and Anxiety Symptoms (IDAS) Subscale: Social Anxiety | The Inventory of Depression and Anxiety Symptoms (IDAS) is a 64-item measure of mood and anxiety disorder symptoms. Each item is rated on a likert scale ranging from 1 (not at all) to 5 (extremely). The measure includes 2 broad subscales of general depresson (20 items; score range: 20-100) and dysphoria (10 items; score range: 10-50) as well as 10 specific symptom scales: Lassitude (6 items; score range: 6-30), Insomnia (6 items; score range: 6-30), Suicidality (6 items; score range: 6-30), Well-Being (8 items; score range: 8-40), Social Anxiety (5 items; score range: 5-25), Appetite Loss (3 items; score range: 3-15), Appetite Gain (3 items; score range: 3-15), Ill Temper (5 items; score range: 5-25), Panic (8 items; score range: 8-40), and Traumatic Intrusions (4 items; score range: 4-20). Higher scores on each subscale except the well-being subscale indicating poorer outcomes. Higher scores on well-being subscale indicates better outcome. | Baseline to post-rTMS |
| Change in Score Inventory of Depression and Anxiety Symptoms (IDAS) Subscale: Panic | The Inventory of Depression and Anxiety Symptoms (IDAS) is a 64-item measure of mood and anxiety disorder symptoms. Each item is rated on a likert scale ranging from 1 (not at all) to 5 (extremely). The measure includes 2 broad subscales of general depresson (20 items; score range: 20-100) and dysphoria (10 items; score range: 10-50) as well as 10 specific symptom scales: Lassitude (6 items; score range: 6-30), Insomnia (6 items; score range: 6-30), Suicidality (6 items; score range: 6-30), Well-Being (8 items; score range: 8-40), Social Anxiety (5 items; score range: 5-25), Appetite Loss (3 items; score range: 3-15), Appetite Gain (3 items; score range: 3-15), Ill Temper (5 items; score range: 5-25), Panic (8 items; score range: 8-40), and Traumatic Intrusions (4 items; score range: 4-20). Higher scores on each subscale except the well-being subscale indicating poorer outcomes. Higher scores on well-being subscale indicates better outcome. | Baseline to post-rTMS |
| Change in Score Inventory of Depression and Anxiety Symptoms (IDAS) Subscale: Traumatic Intrusions | The Inventory of Depression and Anxiety Symptoms (IDAS) is a 64-item measure of mood and anxiety disorder symptoms. Each item is rated on a likert scale ranging from 1 (not at all) to 5 (extremely). The measure includes 2 broad subscales of general depresson (20 items; score range: 20-100) and dysphoria (10 items; score range: 10-50) as well as 10 specific symptom scales: Lassitude (6 items; score range: 6-30), Insomnia (6 items; score range: 6-30), Suicidality (6 items; score range: 6-30), Well-Being (8 items; score range: 8-40), Social Anxiety (5 items; score range: 5-25), Appetite Loss (3 items; score range: 3-15), Appetite Gain (3 items; score range: 3-15), Ill Temper (5 items; score range: 5-25), Panic (8 items; score range: 8-40), and Traumatic Intrusions (4 items; score range: 4-20). Higher scores on each subscale except the well-being subscale indicating poorer outcomes. Higher scores on well-being subscale indicates better outcome. | Baseline to post-rTMS |
| FG002 | Period 3: 120% of MT | All participants who qualify will undergo 6 weeks of open-label rTMS with a stimulation intensity of 120% of MT |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Period 1: 80% of MT | All participants who qualify will undergo 6 weeks of open-label rTMS with a stimulation intensity of 80% of MT |
| BG001 | Period 2: 100% of MT | All participants who qualify will undergo 6 weeks of open-label rTMS with a stimulation intensity of 100% of MT |
| BG002 | Period 3: 120% of MT | All participants who qualify will undergo 6 weeks of open-label rTMS with a stimulation intensity of 120% of MT |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 Score on Child Depression Rating Scale - Revised (CDRS-R) | The Children's Depression Rating Scale-Revised (CDRS-R) is a measure of depression severity in adolescents and children of ages 6 to 12. The measure is completed by a clinician based on interviews with the child/adolescent and their parent. The scale includes 17 symptom areas, each rated on a likert scale ranging from 1 to 5 or 7. Depression severity is indiciated by the CDRS-R raw summary score computed by adding the item responses. The summary score ranges from 17 to 113, with a higher score indicating more severe depression and worse outcome. Change in score for each participant was calculated by subtracting their post-rTMS score from their baseline score, such that a positive value indicates a decrease in score from pre to post-treatment. | Posted | Mean | Standard Deviation | score on a scale | Baseline to post-treatment |
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| Secondary | Change in Score Beck Depression Inventory (BDI-II) | The Beck Depression Inventory (BDI-II) is a 21-item self-report measure of depression severity in adolescents and adults. Each item is measured on a likert scale ranging from 0 to 3. A total score is calculated by adding item responses and can range from 0 to 63, with a higher score indicating more severe depression and worse outcome. Change in score for each participant was calculated by subtracting their post-rTMS score from their baseline score, such that a positive value indicates a decrease in score from pre to post-treatment. | Posted | Mean | Standard Deviation | units on a scale | Baseline to post-treatment |
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| Secondary | Change is Score Columbia Suicide Severity Rating Scale (C-SSRS) | Columbia Suicide Severity Rating Scale (C-SSRS- recent version) is a 10-item measure of suicidal ideation and behavior. Participants were assigned a score between 0 and 8, with higher scores indicating the endorsement of more severe suicidal ideation or behavior (a worse outcome) and a score of "0" indicating no suicidal ideation or behavior (better outcome). Change in score for each participant was calculated by subtracting their post-rTMS score from their baseline score, such that a positive value indicates a decrease in score from pre to post-treatment. | Posted | Mean | Standard Deviation | units on a scale | Baseline to post-treatment |
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| Secondary | Change in Score Temporal Experience of Pleasure Scale (TEPS) | The Temporal Experience of Pleasure Scale (TEPS) is an 18-item self-report measure of the tendency to anticipate and experience pleasure. Each item is rated on a likert scale ranging from 1 (very false for me) to 6 (very true for me). A total score is calculated by adding item responses and ranges from 18 to 108, such that higher scores indicate greater anticipation and experience of pleasure and better outcome. Change in score for each participant was calculated by subtracting their post-rTMS score from their baseline score, such that a positive value indicates a decrease in score from pre to post-treatment. | Posted | Mean | Standard Deviation | units on a scale | Baseline to post-treatment |
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| Secondary | Change in Score Inventory of Depression and Anxiety Symptoms (IDAS) Subscale: General Depression | 64-item measure of mood and anxiety disorder symptoms. Each item is rated on a likert scale ranging from 1 (not at all) to 5 (extremely). The measure includes 2 broad subscales of general depresson (20 items; score range: 20-100) and dysphoria (10 items; score range: 10-50) as well as 10 specific symptom scales: Lassitude (6 items; score range: 6-30), Insomnia (6 items; score range: 6-30), Suicidality (6 items; score range: 6-30), Well-Being (8 items; score range: 8-40), Social Anxiety (5 items; score range: 5-25), Appetite Loss (3 items; score range: 3-15), Appetite Gain (3 items; score range: 3-15), Ill Temper (5 items; score range: 5-25), Panic (8 items; score range: 8-40), and Traumatic Intrusions (4 items; score range: 4-20). Subscale scores are calculated by adding responses for items corresponding to the subscale, with higher scores on each subscale except the well-being subscale indicating poorer outcomes. Higher scores on well-being subscale indicates better outcome. | Posted | Mean | Standard Deviation | units on a scale | Baseline to post-treatment |
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| Secondary | Change in Score Young Mania Rating Scale | The Young Mania Rating Scale is a 11-item measure of manic symptoms. Some items are rated on a likert scale ranging from 0 to 4 and some items are rated on a scale ranging from 0 to 8. Total scores range from 0 to 60, with a higher score indiciating higher levels of mania and worse outcome. Change in score for each participant was calculated by subtracting their post-rTMS score from their baseline score, such that a positive value indicates a decrease in score from pre to post-treatment. | Posted | Mean | Standard Deviation | units on a scale | Baseline to post-treatment |
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| Secondary | Change in Score Inventory of Depression and Anxiety Symptoms (IDAS) Subscale: Dysphoria | The Inventory of Depression and Anxiety Symptoms (IDAS) is a 64-item measure of mood and anxiety disorder symptoms. Each item is rated on a likert scale ranging from 1 (not at all) to 5 (extremely). The measure includes 2 broad subscales of general depresson (20 items; score range: 20-100) and dysphoria (10 items; score range: 10-50) as well as 10 specific symptom scales: Lassitude (6 items; score range: 6-30), Insomnia (6 items; score range: 6-30), Suicidality (6 items; score range: 6-30), Well-Being (8 items; score range: 8-40), Social Anxiety (5 items; score range: 5-25), Appetite Loss (3 items; score range: 3-15), Appetite Gain (3 items; score range: 3-15), Ill Temper (5 items; score range: 5-25), Panic (8 items; score range: 8-40), and Traumatic Intrusions (4 items; score range: 4-20). Higher scores on each subscale except the well-being subscale indicating poorer outcomes. Higher scores on well-being subscale indicates better outcome. | Posted | Mean | Standard Deviation | units on a scale | Baseline to post-rTMS |
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| Secondary | Change in Score Inventory of Depression and Anxiety Symptoms (IDAS) Subscale: Lassitude | The Inventory of Depression and Anxiety Symptoms (IDAS) is a 64-item measure of mood and anxiety disorder symptoms. Each item is rated on a likert scale ranging from 1 (not at all) to 5 (extremely). The measure includes 2 broad subscales of general depresson (20 items; score range: 20-100) and dysphoria (10 items; score range: 10-50) as well as 10 specific symptom scales: Lassitude (6 items; score range: 6-30), Insomnia (6 items; score range: 6-30), Suicidality (6 items; score range: 6-30), Well-Being (8 items; score range: 8-40), Social Anxiety (5 items; score range: 5-25), Appetite Loss (3 items; score range: 3-15), Appetite Gain (3 items; score range: 3-15), Ill Temper (5 items; score range: 5-25), Panic (8 items; score range: 8-40), and Traumatic Intrusions (4 items; score range: 4-20). Higher scores on each subscale except the well-being subscale indicating poorer outcomes. Higher scores on well-being subscale indicates better outcome. | Posted | Mean | Standard Deviation | units on a scale | Baseline to post-rTMS |
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| Secondary | Change in Score Inventory of Depression and Anxiety Symptoms (IDAS) Subscale: Insomnia | The Inventory of Depression and Anxiety Symptoms (IDAS) is a 64-item measure of mood and anxiety disorder symptoms. Each item is rated on a likert scale ranging from 1 (not at all) to 5 (extremely). The measure includes 2 broad subscales of general depresson (20 items; score range: 20-100) and dysphoria (10 items; score range: 10-50) as well as 10 specific symptom scales: Lassitude (6 items; score range: 6-30), Insomnia (6 items; score range: 6-30), Suicidality (6 items; score range: 6-30), Well-Being (8 items; score range: 8-40), Social Anxiety (5 items; score range: 5-25), Appetite Loss (3 items; score range: 3-15), Appetite Gain (3 items; score range: 3-15), Ill Temper (5 items; score range: 5-25), Panic (8 items; score range: 8-40), and Traumatic Intrusions (4 items; score range: 4-20). Higher scores on each subscale except the well-being subscale indicating poorer outcomes. Higher scores on well-being subscale indicates better outcome. | Posted | Mean | Standard Deviation | units on a scale | Baseline to post-rTMS |
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| Secondary | Change in Score Inventory of Depression and Anxiety Symptoms (IDAS) Subscale: Suicidality | The Inventory of Depression and Anxiety Symptoms (IDAS) is a 64-item measure of mood and anxiety disorder symptoms. Each item is rated on a likert scale ranging from 1 (not at all) to 5 (extremely). The measure includes 2 broad subscales of general depresson (20 items; score range: 20-100) and dysphoria (10 items; score range: 10-50) as well as 10 specific symptom scales: Lassitude (6 items; score range: 6-30), Insomnia (6 items; score range: 6-30), Suicidality (6 items; score range: 6-30), Well-Being (8 items; score range: 8-40), Social Anxiety (5 items; score range: 5-25), Appetite Loss (3 items; score range: 3-15), Appetite Gain (3 items; score range: 3-15), Ill Temper (5 items; score range: 5-25), Panic (8 items; score range: 8-40), and Traumatic Intrusions (4 items; score range: 4-20). Higher scores on each subscale except the well-being subscale indicating poorer outcomes. Higher scores on well-being subscale indicates better outcome. | Posted | Mean | Standard Deviation | units on a scale | Baseline to post-rTMS |
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| Secondary | Change in Score Inventory of Depression and Anxiety Symptoms (IDAS) Subscale: Appetite Loss | The Inventory of Depression and Anxiety Symptoms (IDAS) is a 64-item measure of mood and anxiety disorder symptoms. Each item is rated on a likert scale ranging from 1 (not at all) to 5 (extremely). The measure includes 2 broad subscales of general depresson (20 items; score range: 20-100) and dysphoria (10 items; score range: 10-50) as well as 10 specific symptom scales: Lassitude (6 items; score range: 6-30), Insomnia (6 items; score range: 6-30), Suicidality (6 items; score range: 6-30), Well-Being (8 items; score range: 8-40), Social Anxiety (5 items; score range: 5-25), Appetite Loss (3 items; score range: 3-15), Appetite Gain (3 items; score range: 3-15), Ill Temper (5 items; score range: 5-25), Panic (8 items; score range: 8-40), and Traumatic Intrusions (4 items; score range: 4-20). Higher scores on each subscale except the well-being subscale indicating poorer outcomes. Higher scores on well-being subscale indicates better outcome. | Posted | Mean | Standard Deviation | units on a scale | Baseline to post-rTMS |
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| Secondary | Change in Score Inventory of Depression and Anxiety Symptoms (IDAS) Subscale: Appetite Gain | The Inventory of Depression and Anxiety Symptoms (IDAS) is a 64-item measure of mood and anxiety disorder symptoms. Each item is rated on a likert scale ranging from 1 (not at all) to 5 (extremely). The measure includes 2 broad subscales of general depresson (20 items; score range: 20-100) and dysphoria (10 items; score range: 10-50) as well as 10 specific symptom scales: Lassitude (6 items; score range: 6-30), Insomnia (6 items; score range: 6-30), Suicidality (6 items; score range: 6-30), Well-Being (8 items; score range: 8-40), Social Anxiety (5 items; score range: 5-25), Appetite Loss (3 items; score range: 3-15), Appetite Gain (3 items; score range: 3-15), Ill Temper (5 items; score range: 5-25), Panic (8 items; score range: 8-40), and Traumatic Intrusions (4 items; score range: 4-20). Higher scores on each subscale except the well-being subscale indicating poorer outcomes. Higher scores on well-being subscale indicates better outcome. | Posted | Mean | Standard Deviation | units on a scale | Baseline to post-rTMS |
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| Secondary | Change in Score Inventory of Depression and Anxiety Symptoms (IDAS) Subscale: Ill Temper | The Inventory of Depression and Anxiety Symptoms (IDAS) is a 64-item measure of mood and anxiety disorder symptoms. Each item is rated on a likert scale ranging from 1 (not at all) to 5 (extremely). The measure includes 2 broad subscales of general depresson (20 items; score range: 20-100) and dysphoria (10 items; score range: 10-50) as well as 10 specific symptom scales: Lassitude (6 items; score range: 6-30), Insomnia (6 items; score range: 6-30), Suicidality (6 items; score range: 6-30), Well-Being (8 items; score range: 8-40), Social Anxiety (5 items; score range: 5-25), Appetite Loss (3 items; score range: 3-15), Appetite Gain (3 items; score range: 3-15), Ill Temper (5 items; score range: 5-25), Panic (8 items; score range: 8-40), and Traumatic Intrusions (4 items; score range: 4-20). Higher scores on each subscale except the well-being subscale indicating poorer outcomes. Higher scores on well-being subscale indicates better outcome. | Posted | Mean | Standard Deviation | units on a scale | Baseline to post-rTMS |
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| Secondary | Change in Score Inventory of Depression and Anxiety Symptoms (IDAS) Subscale: Well Being | The Inventory of Depression and Anxiety Symptoms (IDAS) is a 64-item measure of mood and anxiety disorder symptoms. Each item is rated on a likert scale ranging from 1 (not at all) to 5 (extremely). The measure includes 2 broad subscales of general depresson (20 items; score range: 20-100) and dysphoria (10 items; score range: 10-50) as well as 10 specific symptom scales: Lassitude (6 items; score range: 6-30), Insomnia (6 items; score range: 6-30), Suicidality (6 items; score range: 6-30), Well-Being (8 items; score range: 8-40), Social Anxiety (5 items; score range: 5-25), Appetite Loss (3 items; score range: 3-15), Appetite Gain (3 items; score range: 3-15), Ill Temper (5 items; score range: 5-25), Panic (8 items; score range: 8-40), and Traumatic Intrusions (4 items; score range: 4-20). Higher scores on each subscale except the well-being subscale indicating poorer outcomes. Higher scores on well-being subscale indicates better outcome. | Posted | Mean | Standard Deviation | units on a scale | Baseline to post-rTMS |
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| Secondary | Change in Score Inventory of Depression and Anxiety Symptoms (IDAS) Subscale: Social Anxiety | The Inventory of Depression and Anxiety Symptoms (IDAS) is a 64-item measure of mood and anxiety disorder symptoms. Each item is rated on a likert scale ranging from 1 (not at all) to 5 (extremely). The measure includes 2 broad subscales of general depresson (20 items; score range: 20-100) and dysphoria (10 items; score range: 10-50) as well as 10 specific symptom scales: Lassitude (6 items; score range: 6-30), Insomnia (6 items; score range: 6-30), Suicidality (6 items; score range: 6-30), Well-Being (8 items; score range: 8-40), Social Anxiety (5 items; score range: 5-25), Appetite Loss (3 items; score range: 3-15), Appetite Gain (3 items; score range: 3-15), Ill Temper (5 items; score range: 5-25), Panic (8 items; score range: 8-40), and Traumatic Intrusions (4 items; score range: 4-20). Higher scores on each subscale except the well-being subscale indicating poorer outcomes. Higher scores on well-being subscale indicates better outcome. | Posted | Mean | Standard Deviation | units on a scale | Baseline to post-rTMS |
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| Secondary | Change in Score Inventory of Depression and Anxiety Symptoms (IDAS) Subscale: Panic | The Inventory of Depression and Anxiety Symptoms (IDAS) is a 64-item measure of mood and anxiety disorder symptoms. Each item is rated on a likert scale ranging from 1 (not at all) to 5 (extremely). The measure includes 2 broad subscales of general depresson (20 items; score range: 20-100) and dysphoria (10 items; score range: 10-50) as well as 10 specific symptom scales: Lassitude (6 items; score range: 6-30), Insomnia (6 items; score range: 6-30), Suicidality (6 items; score range: 6-30), Well-Being (8 items; score range: 8-40), Social Anxiety (5 items; score range: 5-25), Appetite Loss (3 items; score range: 3-15), Appetite Gain (3 items; score range: 3-15), Ill Temper (5 items; score range: 5-25), Panic (8 items; score range: 8-40), and Traumatic Intrusions (4 items; score range: 4-20). Higher scores on each subscale except the well-being subscale indicating poorer outcomes. Higher scores on well-being subscale indicates better outcome. | Posted | Mean | Standard Deviation | units on a scale | Baseline to post-rTMS |
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| Secondary | Change in Score Inventory of Depression and Anxiety Symptoms (IDAS) Subscale: Traumatic Intrusions | The Inventory of Depression and Anxiety Symptoms (IDAS) is a 64-item measure of mood and anxiety disorder symptoms. Each item is rated on a likert scale ranging from 1 (not at all) to 5 (extremely). The measure includes 2 broad subscales of general depresson (20 items; score range: 20-100) and dysphoria (10 items; score range: 10-50) as well as 10 specific symptom scales: Lassitude (6 items; score range: 6-30), Insomnia (6 items; score range: 6-30), Suicidality (6 items; score range: 6-30), Well-Being (8 items; score range: 8-40), Social Anxiety (5 items; score range: 5-25), Appetite Loss (3 items; score range: 3-15), Appetite Gain (3 items; score range: 3-15), Ill Temper (5 items; score range: 5-25), Panic (8 items; score range: 8-40), and Traumatic Intrusions (4 items; score range: 4-20). Higher scores on each subscale except the well-being subscale indicating poorer outcomes. Higher scores on well-being subscale indicates better outcome. | Posted | Mean | Standard Deviation | units on a scale | Baseline to post-rTMS |
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Baseline to follow-up visit 6, 6 months
Not provided
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 | Open Label rTMS | All participants who qualify will undergo 6 weeks of open-label rTMS. Active Repetitive Transcranial Magnetic Stimulation (rTMS): rTMS applies a pulsatile magnetic field to the scalp which painlessly induces electrical currents to the brain. Typically, rTMS is applied to the dorsolateral prefrontal cortex (DLPFC), a brain region that is hypoactive in depression. Whereas standard rTMS stimulates superficial (1cm depth) cortical areas, recent advances in rTMS coil technology support stimulation of deeper (5 cm depth) limbic structures that are also relevant to depression. | 0 | 14 | 2 | 14 | 14 | 14 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicide ideation | Psychiatric disorders | Non-systematic Assessment |
| ||
| Suicide intent | Psychiatric disorders | Non-systematic Assessment |
| ||
| suicide attempt | Psychiatric disorders | Non-systematic Assessment |
| ||
| seizure | Nervous system disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Head and Jaw | General disorders | Non-systematic Assessment |
| ||
| Gastro-intestinal & genito-Urinary | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Nervous system | Nervous system disorders | Non-systematic Assessment |
| ||
| Psychiatric | Psychiatric disorders | Non-systematic Assessment |
| ||
| skin and subcutaneous tissue | General disorders | Non-systematic Assessment |
| ||
| Cardiovascular | Cardiac disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathryn Cullen | University of Minnesota | 612-625-3403 | rega0026@umn.edu |
| Dec 12, 2022 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 9, 2020 | Aug 11, 2021 | ICF_000.pdf |
| ID | Term |
|---|---|
| D061218 | Depressive Disorder, Treatment-Resistant |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| OG002 | Period 3: 120% of MT | All participants who qualify will undergo 6 weeks of open-label rTMS with a stimulation intensity of 120% of MT |
|
|
| Units | Counts |
|---|
| Participants |
|
|
| OG002 |
| Period 3: 120% of MT |
All participants who qualify will undergo 6 weeks of open-label rTMS with a stimulation intensity of 120% of MT |
|
|
| OG002 |
| Period 3: 120% of MT |
All participants who qualify will undergo 6 weeks of open-label rTMS with a stimulation intensity of 120% of MT |
|
|
| OG002 |
| Period 3: 120% of MT |
All participants who qualify will undergo 6 weeks of open-label rTMS with a stimulation intensity of 120% of MT |
|
|
| OG002 |
| Period 3: 120% of MT |
All participants who qualify will undergo 6 weeks of open-label rTMS with a stimulation intensity of 120% of MT |
|
|
| OG002 |
| Period 3: 120% of MT |
All participants who qualify will undergo 6 weeks of open-label rTMS with a stimulation intensity of 120% of MT |
|
|
| OG002 |
| Period 3: 120% of MT |
All participants who qualify will undergo 6 weeks of open-label rTMS with a stimulation intensity of 120% of MT |
|
|
| OG002 |
| Period 3: 120% of MT |
All participants who qualify will undergo 6 weeks of open-label rTMS with a stimulation intensity of 120% of MT |
|
|
| OG002 |
| Period 3: 120% of MT |
All participants who qualify will undergo 6 weeks of open-label rTMS with a stimulation intensity of 120% of MT |
|
|
| OG002 |
| Period 3: 120% of MT |
All participants who qualify will undergo 6 weeks of open-label rTMS with a stimulation intensity of 120% of MT |
|
|
| OG002 |
| Period 3: 120% of MT |
All participants who qualify will undergo 6 weeks of open-label rTMS with a stimulation intensity of 120% of MT |
|
|
| OG002 |
| Period 3: 120% of MT |
All participants who qualify will undergo 6 weeks of open-label rTMS with a stimulation intensity of 120% of MT |
|
|