Rheumatoid Arthritis
Conditions
Brief summary
The purpose of this study is to validate standardized questionnaires on depression for RA and to investigate the frequency of depression with RA. The study will include 2 parts, VADERA I and VADERA II. In VADERA I, 300 participants will be surveyed twice at an interval of 3 months regarding their current emotional condition using standardized questionnaires. On the basis of the results of VADERA I, in VADERA II, the selected questionnaire will be used to assess the prevalence of depression with RA in approximately 1000 participants.
Detailed description
VADERA I is regarded as interventional epidemiologic study. The study was considered as interventional because of the use of the questionnaires and interview for the diagnosis of depression. VADERA II is a cross-sectional epidemiologic study.
Interventions
None listed
Sponsors
Chugai Pharmaceutical
Hoffmann-La Roche
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* VADERA I: Participants diagnosed with RA, who did not suffer from a concurrent, manifest depressive disorder and had been scheduled for a RA consultation at one of the participating clinics * VADERA II: All participants diagnosed with RA who were able to complete the questionnaires and had been scheduled for a RA consultation at one of the participating clinics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PHQ-9 Score at Baseline: VADERA I | Baseline | 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. |
| PHQ-9 Score at Week 12 ± 2: VADERA I | Week 12 ± 2 | 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. |
| BDI-II Score at Baseline: VADERA I | Baseline | 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. |
| BDI-II Score at Week 12 ± 2: VADERA I | Week 12 ± 2 | 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. |
| WHO-5 Index at Baseline: VADERA I | Baseline | 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. |
| WHO-5 Index at Week 12 ± 2: VADERA I | Week 12 ± 2 | 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. |
| MADRS at Baseline: VADERA I | Baseline | 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. |
| MADRS at Week 12 ± 2: VADERA I | Week 12 ± 2 | 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. |
| PHQ-9 Summary Score: VADERA II | Baseline | 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. |
| BDI-II Summary Score: VADERA II | Baseline | 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. |
| 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 | Baseline | 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. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 277 |
| 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. | 1,015 |
| Total | 1,292 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Depression at baseline | 15 | 0 |
| Overall Study | Discontinued after baseline | 39 | 0 |
Baseline characteristics
| Characteristic | Total | VADERA I | VADERA II |
|---|---|---|---|
| Age, Continuous | 60.7 years STANDARD_DEVIATION 12.9 | 59.4 years STANDARD_DEVIATION 13 | 61.0 years STANDARD_DEVIATION 12.9 |
| Sex: Female, Male Female | 982 Participants | 218 Participants | 764 Participants |
| Sex: Female, Male Male | 310 Participants | 59 Participants | 251 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 277 | 0 / 1,015 |
| serious Total, serious adverse events | 0 / 277 | 0 / 1,015 |
Outcome results
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.
Time frame: Baseline
Population: Validation analysis set of VADERA I population. Number of participants analyzed = participants with BDI-II score assessment at baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VADERA I | BDI-II Score at Baseline: VADERA I | 9.3 scores on a scale | Standard Deviation 7.6 |
Comparison: Number of participants analyzed (N) = 258p-value: <0.00195% CI: [0.67, 0.79]t-test, 2 sided
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.
Time frame: Week 12 ± 2
Population: Validation analysis set of VADERA I population. Number of participants analyzed = participants with BDI-II score assessment at specified time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VADERA I | BDI-II Score at Week 12 ± 2: VADERA I | 8.5 scores on a scale | Standard Deviation 7.8 |
Comparison: Number of participants analyzed (N) = 214p-value: <0.00195% CI: [0.64, 0.77]t-test, 2 sided
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.
Time frame: Baseline
Population: Full analysis set of VADERA II population. Number of participants analyzed = participants with BDI-II summary score assessment at baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VADERA I | BDI-II Summary Score: VADERA II | 10.1 scores on a scale | Standard Deviation 8.8 |
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.
Time frame: Baseline
Population: Validation analysis set of VADERA I population. Number of participants analyzed = participants with MADRS assessment at baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VADERA I | MADRS at Baseline: VADERA I | 7.3 scores on a scale | Standard Deviation 6.4 |
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.
Time frame: Week 12 ± 2
Population: Validation analysis set of VADERA I population. Number of participants analyzed = participants with MADRS assessment at specified time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VADERA I | MADRS at Week 12 ± 2: VADERA I | 6.8 scores on a scale | Standard Deviation 6.3 |
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.
Time frame: Baseline
Population: Full analysis set of VADERA II population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VADERA I | 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 score ≥5 | 55.1 percentage of participants |
| VADERA I | 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 | BDI-II score ≥14 | 27.7 percentage of participants |
| VADERA I | 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 score ≥5 or BDI-II score ≥14 | 55.4 percentage of participants |
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.
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VADERA I | PHQ-9 Score at Baseline: VADERA I | 5.2 scores on a scale | Standard Deviation 4 |
Comparison: Number of participants analyzed (N) = 221p-value: <0.00195% CI: [0.59, 0.74]t-test, 2 sided
Comparison: Number of participants analyzed (N) = 222p-value: <0.00195% CI: [0.62, 0.76]t-test, 2 sided
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.
Time frame: Week 12 ± 2
Population: Validation analysis set of VADERA I population. Number of participants analyzed = participants with PHQ-9 score assessment at specified time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VADERA I | PHQ-9 Score at Week 12 ± 2: VADERA I | 4.8 scores on a scale | Standard Deviation 4.2 |
Comparison: Number of participants analyzed (N) = 203p-value: 0.05795% CI: [0.48, 0.66]t-test, 2 sided
Comparison: Number of participants analyzed (N) = 200p-value: <0.00195% CI: [0.67, 0.8]t-test, 2 sided
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.
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VADERA I | PHQ-9 Summary Score: VADERA II | 6.0 scores on a scale | Standard Deviation 4.7 |
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.
Time frame: Baseline
Population: Validation analysis set of VADERA I population. Number of participants analyzed = participants with WHO-5 score assessment at baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VADERA I | WHO-5 Index at Baseline: VADERA I | 61.1 scores on a scale | Standard Deviation 23.6 |
Comparison: Number of participants analyzed (N) = 222p-value: 0.03495% CI: [-0.67, -0.49]t-test, 2 sided
Comparison: Number of participants analyzed (N) = 223p-value: 0.0195% CI: [-0.68, -0.52]t-test, 2 sided
Comparison: Number of participants analyzed (N) = 222p-value: <0.00195% CI: [-0.78, -0.66]t-test, 2 sided
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.
Time frame: Week 12 ± 2
Population: Validation analysis set of VADERA I population. Number of participants analyzed = participants with WHO-5 score assessment at specified time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VADERA I | WHO-5 Index at Week 12 ± 2: VADERA I | 63.9 scores on a scale | Standard Deviation 23.6 |
Comparison: Number of participants analyzed (N) = 202p-value: 0.21995% CI: [-0.63, -0.43]t-test, 2 sided
Comparison: Number of participants analyzed (N) = 199p-value: <0.00195% CI: [-0.75, -0.6]t-test, 2 sided
Comparison: Number of participants analyzed (N) = 205p-value: <0.00195% CI: [-0.82, -0.7]t-test, 2 sided