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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-01691 | Registry Identifier | NCI Clinical Trials Reporting Program (CTRP) |
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| Name | Class |
|---|---|
| Neuronetics | OTHER |
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Cancer is a leading cause of mortality and morbidity worldwide. In addition, cancer is associated with high rates of depression and anxiety among its sufferers, and cancer patients with depression usually have worse treatment outcomes and long-term survival. Surprisingly, many cancer patients with depression do not receive treatment for their depression, perhaps because treatments for cancer-related depression are usually adapted from those used in non-cancer populations and may not be suitable for cancer patients. Moreover, cancer patients with depression are more likely to have a long latency of anti-depressant drug action, negative drug-drug interactions with cancer chemotherapies and an increased susceptibility for systemic side effects. Repetitive transcranial magnetic stimulation (rTMS) is a new treatment modality for depression that affects the brain directly with no systemic side effects and poses no potential for drug-drug interactions. rTMS therapy was recently cleared by the FDA as an antidepressant treatment for treatment-resistant Major Depressive Disorder, and now is being evaluated for a wide array of additional psychiatric indications. This randomized, open label, two-arm, pilot study will investigate the safety, tolerability, feasibility and the efficacy of two forms of rTMS (i.e., left (fast) and right (slow) sided rTMS) in cancer-related depression. The study hypotheses are that rTMS will significantly reduce symptoms of depression and that right-sided slow rTMS will be more effective than left-sided fast rTMS for the treatment of severe anxiety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Right-Sided Low-Frequency rTMS | Experimental | Participants will have rTMS administered at 1Hz to the right dorsolateral Prefrontal Cortex (dlPFC) once a day for 40 minutes, 5 days a week, for a total of six weeks. |
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| Left-Sided High-Frequency rTMS | Experimental | Participants will have rTMS administered at 10Hz to the left dorsolateral Prefrontal Cortex (dlPFC) once a day for 40 minutes, 5 days a week, for a total of six weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (rTMS) | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Change in Depression Severity (HDRS-17) at Weeks 2, 4, and 6 | This measure reports the overall change in depression severity(HDRS-17) from baseline (Week 0) at each follow-up assessment. Overall Change is defined as the score at each subsequent time point minus the score at Baseline. Scale Information: Name: Hamilton Depression Rating Scale (HDRS-17). Construct: The HDRS-17 is a clinician-administered assessment of depressive symptom severity. Total Score Calculation: The total score is calculated by summing the individual scores of all 17 items. Range: Total scores range from 0 to 52. Directionality: Higher values represent a worse outcome (more severe depression), while lower values represent a better outcome. Calculation Logic: The values reported are the absolute difference of outcomes for each treatment arm. For each participant, the relative change is calculated as: Score at Visit - Baseline Score. Negative numbers indicates a reduction in symptom severity (improvement) and a positive number indicates worsening in symptom severity | Baseline (Week 0), Week 2, Week 4 and Week 6. |
| Relative Change in Depression Severity (HDRS-17) at Weeks 2, 4, and 6 | Measure Description: This measure reports the relative (percentage) change in depression severity from baseline (Week 0) at each follow-up assessment. Scale Information: Name: Hamilton Depression Rating Scale (HDRS-17). Construct: The HDRS-17 is a clinician-administered assessment of depressive symptom severity. Total Score Calculation: The total score is calculated by summing the individual scores of all 17 items. Range: Total scores range from 0 to 52. Directionality: Higher values represent a worse outcome (more severe depression), while lower values represent a better outcome. Calculation Logic: The values reported are the mean percentage changes for each treatment arm. For each participant, the relative change is calculated as: ((Score at Visit - Baseline Score) / Baseline Score) * 100. A negative percentage indicates a reduction in symptom severity (improvement). | Baseline (Week 0), Week 2, Week 4 and Week 6 |
| Number of Participants With Treatment-Emergent Side Effects (UKU) | Side effects assessed at Weeks 2, 4, 6 via Udvalg for Kliniske Undersøgelser (UKU) scale (48 items, 0=none to 3=severe; higher=worse). 'Treatment-emergent' worsening is a score increase ≥1 from baseline (Tx #1) on any item with possible/probable relation to intervention. Data reported is the count of participants meeting criteria for any of the clusters. Psychic Cluster: concentration, asthenia, sedation, memory, depression, unrest, sleep/dream changes, emotional indifference. Neurological Cluster: dystonia, rigidity, hypokinesia, hyperkinesia, tremor, akathisia, seizures, paresthesia, headache. Autonomic Cluster: accommodation, salivation, nausea/vomiting, diarrhea, constipation, micturition, polyuria, dizziness, tachycardia, sweating. Other Cluster: rash, pruritus, photosensitivity, weight change, menses changes, galactorrhea, gynecomastia, libido changes, erectile dysfunction. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Change in Anxiety Severity (HAM-A) at Weeks 1, 2, 3, 4, 5, and 6 | Measure Description: The overall change in anxiety severity is assessed using the total score of the Hamilton Anxiety Rating Scale (HAM-A) at each protocol-specified follow-up visit compared to the baseline score at baseline(Week 0) Scale Information: Hamilton Anxiety Rating Scale (HAM-A) Construct: A clinician-rated scale used to measure the severity of a patient's anxiety symptoms, including both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints). Total Score Calculation: The total score is calculated by summing the individual scores of all 14 items. Range: Total scores range from 0 to 56. Directionality: Higher values represent a worse outcome (greater anxiety severity), while lower values represent a better outcome. Calculation Logic: The values reported represent the absolute difference in scores for each treatment arm at every assessment interval minus the score at baseline. |
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Inclusion Criteria:
1. Adults aged 22-80; 2. Have a previous diagnosis of cancer (any type or stage) as confirmed by official medical records; 3. Have a Diagnostic and Statistical Manual (DSM-IV) diagnosis of Major Depressive Disorder; 4. Have a Hamilton Depression Rating (HAM-D) 24-item score of more than 20; 5. Failed to receive satisfactory improvement from one prior antidepressant medication at or above the minimal effective dose and duration in the current depressive episode; 6. All participants must have given signed, informed consent prior to registration in study.
Exclusion Criteria:
1. Participant with any type of brain tumor; 2. Participant with cancer with brain metastases; 3. Evidence of the disease at the time of entry into the trial; 4. Presence or recent history of other concurrent cancers, with the following exceptions: a. Participants with completely treated basal or squamous skin cancers could be included in the study if their physicians deem that they are medically stable, b. Participants with completely treated in situ carcinoma of the breast or cervix could be included in the study if they have not had chemotherapy within the past month and their physicians deem that they are medically stable, c. Participants with pre-cancerous lesions in the colon could be included in the study if they have not had chemotherapy within the past month and their physicians deem that they are medically stable; 5. Participant had recent surgery within two weeks of screening; 6. Participants undergoing chemotherapy; 7. Participant pregnant or nursing; 8. Participant with any metallic object in or around their head; 9. Participant with a pacemaker; 10. Participants with unstable suicidal ideation as determined by the patient's treating psychiatrist; 11. Participants with a substance use disorder within the prior six months; 12. Significant history of head injury/trauma as defined by loss of consciousness for more than one hour; 13. Recurring seizures resulting from the head injury; 14. Clear cognitive sequelae from the head injury and cognitive rehabilitation following the injury; 15. Any disorder that would predispose the participant to seizures; 16. Use of concomitant medications that substantially increase seizure risk.; Such drugs could include neuroleptics (ex. haloperidol, droperidol), clozapine, tricyclic antidepressants (ex. amoxapine, clomipramine), bupropion (particularly the immediate release (IR) formulation), donepezil, psychostimulants (ex. methylphenidate), theophylline and/or other drugs that reduce the seizure threshold. For individuals on any of these medicines, a study clinician evaluated the drugs and doses to determine the risks and benefits. These were then discussed with the individual's Primary Care Physician to determine if the individual could be included in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Mehmet Dokucu, MD, PhD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15695497 | Background | Burgess C, Cornelius V, Love S, Graham J, Richards M, Ramirez A. Depression and anxiety in women with early breast cancer: five year observational cohort study. BMJ. 2005 Mar 26;330(7493):702. doi: 10.1136/bmj.38343.670868.D3. Epub 2005 Feb 4. | |
| 20439832 | Background | George MS, Lisanby SH, Avery D, McDonald WM, Durkalski V, Pavlicova M, Anderson B, Nahas Z, Bulow P, Zarkowski P, Holtzheimer PE 3rd, Schwartz T, Sackeim HA. Daily left prefrontal transcranial magnetic stimulation therapy for major depressive disorder: a sham-controlled randomized trial. Arch Gen Psychiatry. 2010 May;67(5):507-16. doi: 10.1001/archgenpsychiatry.2010.46. |
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In the right-sided 1Hz frequency arm 1 participant withdrew consent after randomization but before treatment start.
In the left-sided 10 Hz frequency arm 1 participant withdrew consent after randomization but before treatment start, another 1 participant withdrew consent after randomization and after a single treatment session but unrelated to any adverse events and 1 participant treatment was ended due to an adverse event determined to be NOT related to treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Right-Sided Low-Frequency rTMS | Participants will have rTMS administered at 1Hz to the right dorsolateral Prefrontal Cortex (dlPFC) once a day for 40 minutes, 5 days a week, for a total of six weeks. Repetitive Transcranial Magnetic Stimulation (rTMS) |
| FG001 | Left-Sided High-Frequency rTMS | Participants will have rTMS administered at 10Hz to the left dorsolateral Prefrontal Cortex (dlPFC) once a day for 40 minutes, 5 days a week, for a total of six weeks. Repetitive Transcranial Magnetic Stimulation (rTMS) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Right-Sided Low-Frequency rTMS | Participants will have rTMS administered at 1Hz to the right dorsolateral Prefrontal Cortex (dlPFC) once a day for 40 minutes, 5 days a week, for a total of six weeks. Repetitive Transcranial Magnetic Stimulation (rTMS) |
| BG001 | Left-Sided High-Frequency rTMS |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | Overall Change in Depression Severity (HDRS-17) at Weeks 2, 4, and 6 | This measure reports the overall change in depression severity(HDRS-17) from baseline (Week 0) at each follow-up assessment. Overall Change is defined as the score at each subsequent time point minus the score at Baseline. Scale Information: Name: Hamilton Depression Rating Scale (HDRS-17). Construct: The HDRS-17 is a clinician-administered assessment of depressive symptom severity. Total Score Calculation: The total score is calculated by summing the individual scores of all 17 items. Range: Total scores range from 0 to 52. Directionality: Higher values represent a worse outcome (more severe depression), while lower values represent a better outcome. Calculation Logic: The values reported are the absolute difference of outcomes for each treatment arm. For each participant, the relative change is calculated as: Score at Visit - Baseline Score. Negative numbers indicates a reduction in symptom severity (improvement) and a positive number indicates worsening in symptom severity | Posted | Mean | Standard Deviation | Score change from baseline | Baseline (Week 0), Week 2, Week 4 and Week 6. |
|
Baseline, Week 2, Week 4, Week 6
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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 | Right-Sided Low-Frequency rTMS | Participants will have rTMS administered at 1Hz to the right dorsolateral Prefrontal Cortex (dlPFC) once a day for 40 minutes, 5 days a week, for a total of six weeks. Repetitive Transcranial Magnetic Stimulation (rTMS) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Accommodation Disturbances | Nervous system disorders | Systematic Assessment |
Pilot trial with small number of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mehmet Dokucu Adjunct Associate Professor of Psychiatry | Dartmouth-Hitchcock Medical Center | 3146071517 | Mehmet.E.Dokucu@hitchcock.org |
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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 | Apr 8, 2022 | May 27, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
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| Baseline (Week 0), Week 2, Week 4, and Week 6 |
| Baseline (Week 0), Week 1- Week 6 (Weekly assessments) |
| Relative Change in Anxiety Severity (HAM-A) at Weeks 1, 2, 3, 4, 5, and 6 | This measure reports the relative (percentage) change in anxiety severity from baseline (Week 0) at each follow-up assessment. Scale name: Hamilton Anxiety Rating Scale (HAM-A). It is a clinician-rated scale used to measure the severity of a patient's anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, measuring both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe). Total score is calculated by summing all 14 items. The total Score ranges from 0 to 56. Higher values represent a worse outcome (greater severity of anxiety), while lower values represent a better outcome. For each protocol-specified time point (Weeks 1-6), the relative change is calculated for as: ((Score at Visit - Baseline Score(Week 0) /Baseline Score)*100. A negative percentage indicates a reduction in symptoms (better outcome). | Baseline(Week 0), Week 1- Week 6 (Weekly assessments) |
| Correlation Between Baseline Anxiety (HAM-A) and Change in Depression Severity (HDRS-17, HAM-D) | This measure assesses the relationship between the severity of anxiety symptoms at the start of treatment and the magnitude of depression improvement at Week 6. Scale 1: Hamilton Anxiety Rating Scale (HAM-A). Measures anxiety severity. Total range: 0 to 56. Higher values = worse outcome. Scale 2: Hamilton Depression Rating Scale (HDRS-17, HAM-D). Measures depression severity. Total range: 0 to 50. Higher values = worse outcome. Statistical Analysis & Interpretation: Change Calculation: Depression change is calculated as (Week 6 Score - Baseline Score). A more negative value represents greater improvement. Coefficient: Spearman's rank correlation coefficient (rho) is used. Interpretation: A positive correlation indicates that higher baseline anxiety is associated with higher (less negative) change scores, meaning less improvement. A negative correlation indicates that higher baseline anxiety is associated with lower (more negative) change scores, meaning greater improvement. | Baseline (Week 0) and Week 6 |
| Correlation Between Baseline Anxiety (HAM-A) and Harm Avoidance (TCI-R) | This measure assesses the relationship between clinical anxiety symptoms and the personality trait of Harm Avoidance at baseline. Scale Information: Scale 1: Hamilton Anxiety Rating Scale (HAM-A). Measures anxiety severity. Total range: 0 to 56. Higher values = worse outcome. Scale 2: Temperament and Character Inventory-Revised (TCI-R) - Harm Avoidance Subscale. Measures the personality trait of Harm Avoidance. Results are reported as standardized T-scores (mean of 50, standard deviation of 10). The typical range for T-scores is 20 to 80. Outcome Direction: For both scales, higher values represent higher levels of the construct (more anxiety and higher harm avoidance). Statistical Analysis & Interpretation: Coefficient: Spearman's rank correlation coefficient (rho). Interpretation: A positive correlation indicates that individuals with higher clinical anxiety symptoms also tend to score higher on the personality trait of Harm Avoidance. | Baseline |
| 18232722 | Background | Janicak PG, O'Reardon JP, Sampson SM, Husain MM, Lisanby SH, Rado JT, Heart KL, Demitrack MA. Transcranial magnetic stimulation in the treatment of major depressive disorder: a comprehensive summary of safety experience from acute exposure, extended exposure, and during reintroduction treatment. J Clin Psychiatry. 2008 Feb;69(2):222-32. doi: 10.4088/jcp.v69n0208. |
| 21807002 | Background | Machado S, Paes F, Velasques B, Teixeira S, Piedade R, Ribeiro P, Nardi AE, Arias-Carrion O. Is rTMS an effective therapeutic strategy that can be used to treat anxiety disorders? Neuropharmacology. 2012 Jan;62(1):125-34. doi: 10.1016/j.neuropharm.2011.07.024. Epub 2011 Jul 27. |
| 17573044 | Background | O'Reardon JP, Solvason HB, Janicak PG, Sampson S, Isenberg KE, Nahas Z, McDonald WM, Avery D, Fitzgerald PB, Loo C, Demitrack MA, George MS, Sackeim HA. Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized controlled trial. Biol Psychiatry. 2007 Dec 1;62(11):1208-16. doi: 10.1016/j.biopsych.2007.01.018. Epub 2007 Jun 14. |
| 21631403 | Background | Paes F, Machado S, Arias-Carrion O, Velasques B, Teixeira S, Budde H, Cagy M, Piedade R, Ribeiro P, Huston JP, Sack AT, Nardi AE. The value of repetitive transcranial magnetic stimulation (rTMS) for the treatment of anxiety disorders: an integrative review. CNS Neurol Disord Drug Targets. 2011 Aug;10(5):610-20. doi: 10.2174/187152711796234943. |
| 18447962 | Background | Schutter DJ. Antidepressant efficacy of high-frequency transcranial magnetic stimulation over the left dorsolateral prefrontal cortex in double-blind sham-controlled designs: a meta-analysis. Psychol Med. 2009 Jan;39(1):65-75. doi: 10.1017/S0033291708003462. Epub 2008 Apr 30. |
| 20361902 | Background | Slotema CW, Blom JD, Hoek HW, Sommer IE. Should we expand the toolbox of psychiatric treatment methods to include Repetitive Transcranial Magnetic Stimulation (rTMS)? A meta-analysis of the efficacy of rTMS in psychiatric disorders. J Clin Psychiatry. 2010 Jul;71(7):873-84. doi: 10.4088/JCP.08m04872gre. Epub 2010 Mar 9. |
Participants will have rTMS administered at 10Hz to the left dorsolateral Prefrontal Cortex (dlPFC) once a day for 40 minutes, 5 days a week, for a total of six weeks. Repetitive Transcranial Magnetic Stimulation (rTMS) |
| BG002 | Total | Total of all reporting groups |
| 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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| Hamilton Depression Rating Scale (Also known as HAM-D or HDRS) | Clinician-administered assessment used to quantify the severity of depressive symptoms. It assesses depressed mood, guilt, suicide ideation, insomnia, agitation or retardation, anxiety, and somatic symptoms. Individual items are scored on either a 3-point scale (0-2) or a 5-point scale (0-4), depending on the item. The total score is calculated by summing the scores of the first 17 items. Scores range from 0 to 52. Higher values represent a worse outcome (greater severity of depression), while lower values represent a better outcome (remission is typically defined as a score of ≤ 7). | Mean | Standard Deviation | units on a scale |
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| The Hamilton Anxiety Rating Scale (HAM-A) | Clinician-rated scale used to measure the severity of a patient's anxiety symptoms on 14 items, each defined by a series of symptoms, measuring both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe). The total score is calculated by summing the scores of all 14 items. The total score ranges from 0 to 56. Outcome Direction: Higher values represent a worse outcome (greater severity of anxiety), while lower values represent a better outcome. | Mean | Standard Deviation | units on a scale |
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| OG000 | Right-Sided Low-Frequency rTMS | Participants will have rTMS administered at 1Hz to the right dorsolateral Prefrontal Cortex (dlPFC) once a day for 40 minutes, 5 days a week, for a total of six weeks. Repetitive Transcranial Magnetic Stimulation (rTMS) |
| OG001 | Left-Sided High-Frequency rTMS | Participants will have rTMS administered at 10Hz to the left dorsolateral Prefrontal Cortex (dlPFC) once a day for 40 minutes, 5 days a week, for a total of six weeks. Repetitive Transcranial Magnetic Stimulation (rTMS) |
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| Primary | Relative Change in Depression Severity (HDRS-17) at Weeks 2, 4, and 6 | Measure Description: This measure reports the relative (percentage) change in depression severity from baseline (Week 0) at each follow-up assessment. Scale Information: Name: Hamilton Depression Rating Scale (HDRS-17). Construct: The HDRS-17 is a clinician-administered assessment of depressive symptom severity. Total Score Calculation: The total score is calculated by summing the individual scores of all 17 items. Range: Total scores range from 0 to 52. Directionality: Higher values represent a worse outcome (more severe depression), while lower values represent a better outcome. Calculation Logic: The values reported are the mean percentage changes for each treatment arm. For each participant, the relative change is calculated as: ((Score at Visit - Baseline Score) / Baseline Score) * 100. A negative percentage indicates a reduction in symptom severity (improvement). | Posted | Mean | Standard Deviation | Percentage change from baseline | Baseline (Week 0), Week 2, Week 4 and Week 6 |
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| Primary | Number of Participants With Treatment-Emergent Side Effects (UKU) | Side effects assessed at Weeks 2, 4, 6 via Udvalg for Kliniske Undersøgelser (UKU) scale (48 items, 0=none to 3=severe; higher=worse). 'Treatment-emergent' worsening is a score increase ≥1 from baseline (Tx #1) on any item with possible/probable relation to intervention. Data reported is the count of participants meeting criteria for any of the clusters. Psychic Cluster: concentration, asthenia, sedation, memory, depression, unrest, sleep/dream changes, emotional indifference. Neurological Cluster: dystonia, rigidity, hypokinesia, hyperkinesia, tremor, akathisia, seizures, paresthesia, headache. Autonomic Cluster: accommodation, salivation, nausea/vomiting, diarrhea, constipation, micturition, polyuria, dizziness, tachycardia, sweating. Other Cluster: rash, pruritus, photosensitivity, weight change, menses changes, galactorrhea, gynecomastia, libido changes, erectile dysfunction. | Treatment-Emergent Side Effects show % of participants with worsening of adverse effects | Posted | Count of Participants | Participants | Baseline (Week 0), Week 2, Week 4, and Week 6 |
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| Secondary | Overall Change in Anxiety Severity (HAM-A) at Weeks 1, 2, 3, 4, 5, and 6 | Measure Description: The overall change in anxiety severity is assessed using the total score of the Hamilton Anxiety Rating Scale (HAM-A) at each protocol-specified follow-up visit compared to the baseline score at baseline(Week 0) Scale Information: Hamilton Anxiety Rating Scale (HAM-A) Construct: A clinician-rated scale used to measure the severity of a patient's anxiety symptoms, including both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints). Total Score Calculation: The total score is calculated by summing the individual scores of all 14 items. Range: Total scores range from 0 to 56. Directionality: Higher values represent a worse outcome (greater anxiety severity), while lower values represent a better outcome. Calculation Logic: The values reported represent the absolute difference in scores for each treatment arm at every assessment interval minus the score at baseline. | Posted | Mean | Standard Deviation | Change in score from baseline | Baseline (Week 0), Week 1- Week 6 (Weekly assessments) |
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| Secondary | Relative Change in Anxiety Severity (HAM-A) at Weeks 1, 2, 3, 4, 5, and 6 | This measure reports the relative (percentage) change in anxiety severity from baseline (Week 0) at each follow-up assessment. Scale name: Hamilton Anxiety Rating Scale (HAM-A). It is a clinician-rated scale used to measure the severity of a patient's anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, measuring both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe). Total score is calculated by summing all 14 items. The total Score ranges from 0 to 56. Higher values represent a worse outcome (greater severity of anxiety), while lower values represent a better outcome. For each protocol-specified time point (Weeks 1-6), the relative change is calculated for as: ((Score at Visit - Baseline Score(Week 0) /Baseline Score)*100. A negative percentage indicates a reduction in symptoms (better outcome). | Posted | Mean | Standard Deviation | Percentage change from baseline(Week 0) | Baseline(Week 0), Week 1- Week 6 (Weekly assessments) |
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| Secondary | Correlation Between Baseline Anxiety (HAM-A) and Change in Depression Severity (HDRS-17, HAM-D) | This measure assesses the relationship between the severity of anxiety symptoms at the start of treatment and the magnitude of depression improvement at Week 6. Scale 1: Hamilton Anxiety Rating Scale (HAM-A). Measures anxiety severity. Total range: 0 to 56. Higher values = worse outcome. Scale 2: Hamilton Depression Rating Scale (HDRS-17, HAM-D). Measures depression severity. Total range: 0 to 50. Higher values = worse outcome. Statistical Analysis & Interpretation: Change Calculation: Depression change is calculated as (Week 6 Score - Baseline Score). A more negative value represents greater improvement. Coefficient: Spearman's rank correlation coefficient (rho) is used. Interpretation: A positive correlation indicates that higher baseline anxiety is associated with higher (less negative) change scores, meaning less improvement. A negative correlation indicates that higher baseline anxiety is associated with lower (more negative) change scores, meaning greater improvement. | Posted | Number | 95% Confidence Interval | Spearman Rho | Baseline (Week 0) and Week 6 |
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| Secondary | Correlation Between Baseline Anxiety (HAM-A) and Harm Avoidance (TCI-R) | This measure assesses the relationship between clinical anxiety symptoms and the personality trait of Harm Avoidance at baseline. Scale Information: Scale 1: Hamilton Anxiety Rating Scale (HAM-A). Measures anxiety severity. Total range: 0 to 56. Higher values = worse outcome. Scale 2: Temperament and Character Inventory-Revised (TCI-R) - Harm Avoidance Subscale. Measures the personality trait of Harm Avoidance. Results are reported as standardized T-scores (mean of 50, standard deviation of 10). The typical range for T-scores is 20 to 80. Outcome Direction: For both scales, higher values represent higher levels of the construct (more anxiety and higher harm avoidance). Statistical Analysis & Interpretation: Coefficient: Spearman's rank correlation coefficient (rho). Interpretation: A positive correlation indicates that individuals with higher clinical anxiety symptoms also tend to score higher on the personality trait of Harm Avoidance. | Posted | Number | 95% Confidence Interval | Spearman Rho | Baseline |
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| 0 |
| 12 |
| 0 |
| 12 |
| 12 |
| 12 |
| EG001 | Left-Sided High-Frequency rTMS | Participants will have rTMS administered at 10Hz to the left dorsolateral Prefrontal Cortex (dlPFC) once a day for 40 minutes, 5 days a week, for a total of six weeks. Repetitive Transcranial Magnetic Stimulation (rTMS) | 0 | 8 | 0 | 8 | 8 | 8 |
| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Increased Salivation | Nervous system disorders | Systematic Assessment |
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| Increased Tendency to Sweating | Nervous system disorders | Systematic Assessment |
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| Micturition Disturbances | Nervous system disorders | Systematic Assessment |
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| Nausea Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Orthostatic Dizziness | Nervous system disorders | Systematic Assessment |
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| Palpitations Tachycardia | Cardiac disorders | Systematic Assessment |
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| Polyuria Polydipsia | Nervous system disorders | Systematic Assessment |
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| Reduced Salivation | Nervous system disorders | Systematic Assessment |
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| Akathisia | Nervous system disorders | Systematic Assessment |
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| Hypokinesia Akinesia | Nervous system disorders | Systematic Assessment |
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| Paraesthesias | Nervous system disorders | Systematic Assessment |
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| Tremor | Nervous system disorders | Systematic Assessment |
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| Amenorrhea | General disorders | Systematic Assessment |
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| Diminished Sexual Desire | General disorders | Systematic Assessment |
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| Dry Vagina | General disorders | Systematic Assessment |
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| Ejaculatory Dysfunction | Psychiatric disorders | Systematic Assessment |
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| Erectile Dysfunction | Psychiatric disorders | Systematic Assessment |
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| Headache | General disorders | Systematic Assessment |
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| Increased Sexual Desire | Psychiatric disorders | Systematic Assessment |
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| Migraine | Nervous system disorders | Systematic Assessment |
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| Orgastic Dysfunction | General disorders | Systematic Assessment |
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| Petechial | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Tension headache | Nervous system disorders | Systematic Assessment |
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| Weight gain | General disorders | Systematic Assessment |
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| Weight loss | General disorders | Systematic Assessment |
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| Asthenia Lassitude lncreased Fatigability | Psychiatric disorders | Systematic Assessment |
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| Concentration Difficulties | Psychiatric disorders | Systematic Assessment |
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| Depression | Psychiatric disorders | Systematic Assessment |
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| Emotional indifference | Psychiatric disorders | Systematic Assessment |
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| Failing Memory | Psychiatric disorders | Systematic Assessment |
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| Increased Dream Activity | Psychiatric disorders | Systematic Assessment |
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| Increased Duration of Sleep | Psychiatric disorders | Systematic Assessment |
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| Reduced Duration of Sleep | Psychiatric disorders | Systematic Assessment |
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| Sleepiness Sedation | Psychiatric disorders | Systematic Assessment |
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| Tension lnner Unrest | Psychiatric disorders | Systematic Assessment |
|
Not provided
Not provided
| Week 6(Relative change) |
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| Week 4 |
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| Week 6 |
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| Week 3(Overall change) |
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| Week 4(Overall change) |
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| Week 5(Overall change) |
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| Week 6(Overall change) |
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| Week 3(Relative change) |
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| Week 4(Relative change) |
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| Week 5 (Change) |
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| Week 6(Change) |
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