Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Change in HAM-D Score From Baseline to Week 1 |
The Hamilton Rating Scale for Depression (HAM-D) total score comprises a sum of the 17 individual item scores which ranges from 0 to 52. Higher scores indicate a greater degree of depression. |
Baseline, Week 1 |
|
Primary |
Change in CDRS-R Score From Baseline to Week 1 |
The Children's Depression Rating Scale-Revised (CDRS-R) total score ranges from 17 (minimal or no symptoms of depression) to 113 (indicative of depression) is a semi-structured, clinician-rated instrument designed for use with children and adolescents between the ages of 6 to 17 years of age and their caregivers. The CDRS-R evaluates the presence and severity of symptoms commonly associated with depression in childhood. |
Baseline, Week 1 |
|
Primary |
Change in HAM-D Score From Baseline to Week 2 |
The Hamilton Rating Scale for Depression (HAM-D) total score comprises a sum of the 17 individual item scores which ranges from 0 to 52. Higher scores indicate a greater degree of depression. |
Baseline, Week 2 |
|
Primary |
Change in CDRS-R Score From Baseline to Week 2 |
The Children's Depression Rating Scale-Revised (CDRS-R) total score ranges from 17 (minimal or no symptoms of depression) to 113 (indicative of depression) is a semi-structured, clinician-rated instrument designed for use with children and adolescents between the ages of 6 to 17 years of age and their caregivers. The CDRS-R evaluates the presence and severity of symptoms commonly associated with depression in childhood. |
Baseline, Week 2 |
|
Primary |
Change in HAM-D Score From Baseline to Week 3 |
The Hamilton Rating Scale for Depression (HAM-D) total score comprises a sum of the 17 individual item scores which ranges from 0 to 52. Higher scores indicate a greater degree of depression. |
Baseline, Week 3 |
|
Primary |
Change in CDRS-R Score From Baseline to Week 3 |
The Children's Depression Rating Scale-Revised (CDRS-R) total score ranges from 17 (minimal or no symptoms of depression) to 113 (indicative of depression) is a semi-structured, clinician-rated instrument designed for use with children and adolescents between the ages of 6 to 17 years of age and their caregivers. The CDRS-R evaluates the presence and severity of symptoms commonly associated with depression in childhood. |
Baseline, Week 3 |
|
Primary |
Change in HAM-D Score From Baseline to Week 4 |
The Hamilton Rating Scale for Depression (HAM-D) total score comprises a sum of the 17 individual item scores which ranges from 0 to 52. Higher scores indicate a greater degree of depression. |
Baseline, Week 4 |
|
Primary |
Change in CDRS-R Score From Baseline to Week 4 |
The Children's Depression Rating Scale-Revised (CDRS-R) total score ranges from 17 (minimal or no symptoms of depression) to 113 (indicative of depression) is a semi-structured, clinician-rated instrument designed for use with children and adolescents between the ages of 6 to 17 years of age and their caregivers. The CDRS-R evaluates the presence and severity of symptoms commonly associated with depression in childhood. |
Baseline, Week 4 |
|
Secondary |
Number of Occurrences of Passive Suicidal Ideation |
Columbia Suicide Severity Rating Scale (C-SSRS) is a semi-structured interview that has "yes or no" answers to assess the likelihood of a subject harming themselves, including "yes/no" to passive suicidal ideation. Participants indicating a "yes" response to any of these questions were reported as having passive suicidal ideation. Each participant was assessed at 8 timepoints during the study. |
Up to 12 Weeks Post-Treatment Completion, a total of up to 16 weeks |
|
Secondary |
Number of Participants Who Completed the Study |
Feasibility for this protocol is partially determined by completion rate. Treatment completion is defined in this protocol by 75% of treatments completed (15/20) per subject. This will be measured through completion of Week 4 of treatment (Week 5 of protocol when including screening phase). |
Up to Week 5 |
|
Secondary |
Number of Participants Who Withdrew From the Study |
Feasibility for this protocol is partially determined by withdrawal rate. Withdrawal is defined as no more than 1 out of 5 subjects (20% of participants) withdrawing due to intolerable side effects caused by treatment or persistent depressive symptoms. This will be measured through completion of Week 4 of treatment (Week 5 of protocol when including screening phase). |
Up to Week 5 |
|
Secondary |
Durability of Treatment Effect With HAM-D Scores |
Change in scores of Hamilton Depression Rating Scale (HAM-D) will be evaluated comparing Baseline to each follow-up phase at 1 week, 4 weeks, and 12 weeks post-treatment. The (HAM-D) total score comprises a sum of the 17 individual item scores which ranges from 0 to 52. Higher scores indicate a greater degree of depression. |
From Baseline up to 12 Weeks Post-Treatment Completion, a total of up to 16 weeks |
|
Secondary |
Durability of Treatment Effect With CDRS-R Scores |
Change in scores of Children Depression Rating Scale Revised (CDRS-R) during follow-up phase at 1 week, 4 weeks, and 12 weeks post-treatment. The Children's Depression Rating Scale-Revised (CDRS-R) total score ranges from 17 (minimal or no symptoms of depression) to 113 (indicative of depression) is a semi-structured, clinician-rated instrument designed for use with children and adolescents between the ages of 6 to 17 years of age and their caregivers. The CDRS-R evaluates the presence and severity of symptoms commonly associated with depression in childhood. |
Up to 12 Weeks Post-Treatment Completion, a total of up to 16 weeks |
|
Secondary |
Number of Occurrences of Non-Suicidal Self Injurious Behavior Through SITBI |
Self Injurious Thoughts and Behavior Interview (SITBI) is a semi-structured interview commonly used and administered by a clinician to determine if self-harm behavior has been present since the last visit. This will be evaluated at baseline (screening), once per week during the treatment phase, and at each follow up visit. |
Up to 12 Weeks Post-Treatment Completion, a total of up to 16 weeks |
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