Trial Outcomes & Findings for Repetitive Transcranial Magnetic Stimulation in Cancer Patients With Depression and Anxiety (NCT NCT01701284)

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.

Repetitive Transcranial Magnetic Stimulation in Cancer Patients With Depression and Anxiety

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

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).

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: 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.

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).

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.

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.