| Primary | PHQ-9 Score at Baseline: VADERA I | The PHQ-9 is a self-reported questionnaire measuring depressive symptoms.This is a nine item measure with a response score for each item on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). Thus, the total score ranges from 0 to 27; with 0-4 being minimum indicating no depressive symptoms, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, 20-27 severe depression. | Validation analysis set of VADERA I population defined as all study participants diagnosed with RA, who had given informed consent, and had no documented depression at baseline. Number of participants analyzed = participants with PHQ-9 score assessment at baseline. | Posted | | Mean | Standard Deviation | scores on a scale | | Baseline | | | | ID | Title | Description |
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| OG000 | VADERA I | RA participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the WHO-5, PHQ-9 and BDI-II questionnaires and a subsequent structured interview using MADRS at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments. |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| Number of participants analyzed (N) = 221 | t-test, 2 sided | | <0.001 | Convergent Validity Criterion Correlation coefficient (ρ) > |0.50| | Spearman correlation coefficient | 0.67 | | | 2-Sided | 95 | 0.59 | 0.74 | | | Convergent correlation between PHQ-9 and MADRS | No | Superiority or Other | | | |
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| Primary | PHQ-9 Score at Week 12 ± 2: VADERA I | The PHQ-9 is a self-reported questionnaire measuring depressive symptoms. This is a nine item measure with a response score for each item on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). Thus, the total score ranges from 0 to 27; with 0-4 being minimum indicating no depressive symptoms, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, 20-27 severe depression. | Validation analysis set of VADERA I population. Number of participants analyzed = participants with PHQ-9 score assessment at specified time-point. | Posted | | Mean | Standard Deviation | scores on a scale | | Week 12 ± 2 | | | | ID | Title | Description |
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| OG000 | VADERA I | RA participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the WHO-5, PHQ-9 and BDI-II questionnaires and a subsequent structured interview using MADRS at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments. |
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| Primary | BDI-II Score at Baseline: VADERA I | BDI-II Scale is a 21-item self-reported questionnaire which measures the existence and severity of symptoms of depression. Each of the 21 items on BDI-II tool represents a depressive symptom. The symptoms are each scored on a 4-point Likert scale of 0 to 3 (0=symptom is absent; 3=symptom is severe). Scores for each symptom are added up to obtain the total scores for all 21 items. Total score ranges from 0-63; of which 0-8 is considered no depression, 0-13 is minimal depression, 14-19 is mild depression, 20-28 is moderate depression and 29-63 is severe depression. | Validation analysis set of VADERA I population. Number of participants analyzed = participants with BDI-II score assessment at baseline. | Posted | | Mean | Standard Deviation | scores on a scale | | Baseline | | | | ID | Title | Description |
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| OG000 | VADERA I | RA participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the WHO-5, PHQ-9 and BDI-II questionnaires and a subsequent structured interview using MADRS at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments. |
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| Primary | BDI-II Score at Week 12 ± 2: VADERA I | BDI-II Scale is a 21-item self-reported questionnaire which measures the existence and severity of symptoms of depression. Each of the 21 items on BDI-II tool represent a depressive symptom. The symptoms are each scored on a 4-point Likert scale of 0 to 3 (0=symptom is absent; 3=symptom is severe). Scores for each symptom are added up to obtain the total scores for all 21 items. Total score ranges from 0-63; of which 0-8 is considered no depression, 0-13 is minimal depression, 14-19 is mild depression, 20-28 is moderate depression and 29-63 is severe depression. | Validation analysis set of VADERA I population. Number of participants analyzed = participants with BDI-II score assessment at specified time-point. | Posted | | Mean | Standard Deviation | scores on a scale | | Week 12 ± 2 | | | | ID | Title | Description |
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| OG000 | VADERA I | RA participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the WHO-5, PHQ-9 and BDI-II questionnaires and a subsequent structured interview using MADRS at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments. |
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| Primary | WHO-5 Index at Baseline: VADERA I | WHO-5 questionnaire contains five items related to cheerfulness, calmness, feelings of vigor, feelings of being well rested after sleep, and personal interest. The respondent rated each question on a 6-point scale ranging from 0 ("at no time") to 5 ("all of the time") according to the proportion of time over the preceding 2 weeks that applied to the attribute in question. Scores were summated, with raw score ranging from 0 to 25. Then the scores were transformed to 0-100 by multiplying by 4, whereas 0 indicated the worst possible emotional well-being and 100 the best. | Validation analysis set of VADERA I population. Number of participants analyzed = participants with WHO-5 score assessment at baseline. | Posted | | Mean | Standard Deviation | scores on a scale | | Baseline | | | | ID | Title | Description |
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| OG000 | VADERA I | RA participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the WHO-5, PHQ-9 and BDI-II questionnaires and a subsequent structured interview using MADRS at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments. |
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| Primary | WHO-5 Index at Week 12 ± 2: VADERA I | WHO-5 questionnaire contains five items related to cheerfulness, calmness, feelings of vigor, feelings of being well rested after sleep, and personal interest. The respondent rated each question on a 6-point scale ranging from 0 ("at no time") to 5 ("all of the time") according to the proportion of time over the preceding 2 weeks that applied to the attribute in question. Scores were summated, with raw score ranging from 0 to 25. Then the scores were transformed to 0-100 by multiplying by 4, whereas 0 indicated the worst possible emotional well-being and 100 the best. | Validation analysis set of VADERA I population. Number of participants analyzed = participants with WHO-5 score assessment at specified time-point. | Posted | | Mean | Standard Deviation | scores on a scale | | Week 12 ± 2 | | | | ID | Title | Description |
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| OG000 | VADERA I | RA participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the WHO-5, PHQ-9 and BDI-II questionnaires and a subsequent structured interview using MADRS at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments. |
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| Primary | MADRS at Baseline: VADERA I | The MADRS, an interview addressing 10 characteristics of depressive symptomatology, was used as the gold standard. The symptom-related information provided by each participant was rated on item-specific scales ranging from 0 (best) to 6 (worst) in order to evaluate individual symptom severity. Total score was sum of 10 characteristics, ranging from 0 to 60; 0, no depression; 60, severely depressed. Sum scores exceeding 12 indicated clinical relevance suggested mild to severe symptomatology. | Validation analysis set of VADERA I population. Number of participants analyzed = participants with MADRS assessment at baseline. | Posted | | Mean | Standard Deviation | scores on a scale | | Baseline | | | | ID | Title | Description |
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| OG000 | VADERA I | RA participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the WHO-5, PHQ-9 and BDI-II questionnaires and a subsequent structured interview using MADRS at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments. |
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| Primary | MADRS at Week 12 ± 2: VADERA I | The MADRS, an interview addressing 10 characteristics of depressive symptomatology, was used as the gold standard. The symptom-related information provided by each participant was rated on item-specific scales ranging from 0 (best) to 6 (worst) in order to evaluate individual symptom severity. Total score was sum of 10 characteristics, ranging between 0 to 60; 0, no depression; 60, severely depressed. Sum scores exceeding 12 indicated clinical relevance suggested mild to severe symptomatology. | Validation analysis set of VADERA I population. Number of participants analyzed = participants with MADRS assessment at specified time-point. | Posted | | Mean | Standard Deviation | scores on a scale | | Week 12 ± 2 | | | | ID | Title | Description |
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| OG000 | VADERA I | RA participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the WHO-5, PHQ-9 and BDI-II questionnaires and a subsequent structured interview using MADRS at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments. |
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| Primary | PHQ-9 Summary Score: VADERA II | The PHQ-9 is a self-reported questionnaire measuring depressive symptoms. This is a nine item measure with a response score for each item on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). Thus, the total score ranges from 0 to 27; with 0-4 being minimum indicating no depressive symptoms, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, 20-27 severe depression. | Full analysis set of VADERA II population defined as all study participants diagnosed with RA, who had given informed consent, and had completed at least one of the depression questionnaires. Number of participants analyzed = participants with PHQ-9 summary score assessment at baseline. | Posted | | Mean | Standard Deviation | scores on a scale | | Baseline | | | | ID | Title | Description |
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| OG000 | VADERA II | All RA participants who were able to complete the PHQ-9 and BDI-II questionnaires, and had been scheduled for a RA consultation at one of the participating clinics were eligible for participation. |
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| Primary | BDI-II Summary Score: VADERA II | BDI-II Scale is a 21-item self-reported questionnaire which measures the existence and severity of symptoms of depression. Each of the 21 items on BDI-II tool represent a depressive symptom. The symptoms are each scored on a 4-point Likert scale of 0 to 3 (0=symptom is absent; 3=symptom is severe). Scores for each symptom are added up to obtain the total scores for all 21 items. Total score ranges from 0-63; of which 0-8 is considered no depression, 0-13 is minimal depression, 14-19 is mild depression, 20-28 is moderate depression and 29-63 is severe depression. | Full analysis set of VADERA II population. Number of participants analyzed = participants with BDI-II summary score assessment at baseline. | Posted | | Mean | Standard Deviation | scores on a scale | | Baseline | | | | ID | Title | Description |
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| OG000 | VADERA II | All RA participants who were able to complete the PHQ-9 and BDI-II questionnaires, and had been scheduled for a RA consultation at one of the participating clinics were eligible for participation. |
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| Primary | Percentage of Participants With Prevalence of Depressive Symptomatology Based on a BDI-II Score Greater Than or Equal to (≥)14 or PHQ-9 Score ≥5: VADERA II | PHQ-9 is a self-reported questionnaire measuring depressive symptoms. This is a 9-item measure with a response score for each item on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 27; with 0-4 indicating no depressive symptoms, 5-9 mild, 10-14 moderate, 15-19 moderately severe, and 20-27 severe depression. BDI-II Scale is a 21-item self-reported questionnaire measuring existence and severity of depression symptoms. Symptoms are each scored on a 4-point scale of 0 (no symptom) to 3 (severe symptom). Total score ranges from 0-63; of which 0-8 is considered no depression, 0-13 minimal, 14-19 mild, 20-28 moderate, and 29-63 severe depression. Participants with a BDI-II score ≥14 or a PHQ-9 score ≥5 were classified as having depressive symptomatology. Participants were evaluated by positive depressive symptomatology for each questionnaire as well as being positive for both questionnaires combined or at least one of the questionnaires. | Full analysis set of VADERA II population. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Baseline | | | | ID | Title | Description |
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| OG000 | VADERA II | All RA participants who were able to complete the PHQ-9 and BDI-II questionnaires, and had been scheduled for a RA consultation at one of the participating clinics were eligible for participation. |
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