Trial Outcomes & Findings for Study for Validation of Standardized Questionnaires on Depression and Investigation of the Frequency of Depression in Rheumatoid Arthritis (RA) Participants (NCT NCT02485483)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

1292 participants

Primary outcome timeframe

Baseline

Results posted on

2016-10-17

Participant Flow

Participant milestones

Participant milestones
Measure	VADERA I Rheumatoid arthritis (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 World Health Organization Five Well-Being Index (WHO-5), Patient Health Questionnaire-9 (PHQ-9) and Beck Depression Inventory (2nd edition) (BDI-II) questionnaires and a subsequent structured interview using Montgomery-Åsberg Depression Rating Scale (MADRS) at 2 time-points (T0 and T1 \[12 ± 2 weeks\]) with a 10-14 week interval between assessments.	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.
Overall Study STARTED	277	1015
Overall Study COMPLETED	223	1015
Overall Study NOT COMPLETED	54	0

Reasons for withdrawal

Reasons for withdrawal
Measure	VADERA I Rheumatoid arthritis (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 World Health Organization Five Well-Being Index (WHO-5), Patient Health Questionnaire-9 (PHQ-9) and Beck Depression Inventory (2nd edition) (BDI-II) questionnaires and a subsequent structured interview using Montgomery-Åsberg Depression Rating Scale (MADRS) at 2 time-points (T0 and T1 \[12 ± 2 weeks\]) with a 10-14 week interval between assessments.	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.
Overall Study Depression at baseline	15	0
Overall Study Discontinued after baseline	39	0

Baseline Characteristics

Study for Validation of Standardized Questionnaires on Depression and Investigation of the Frequency of Depression in Rheumatoid Arthritis (RA) Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	VADERA I n=277 Participants 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.	VADERA II n=1015 Participants 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.	Total n=1292 Participants Total of all reporting groups
Age, Continuous	59.4 years STANDARD_DEVIATION 13.0 • n=5 Participants	61.0 years STANDARD_DEVIATION 12.9 • n=7 Participants	60.7 years STANDARD_DEVIATION 12.9 • n=5 Participants
Sex: Female, Male Female	218 Participants n=5 Participants	764 Participants n=7 Participants	982 Participants n=5 Participants
Sex: Female, Male Male	59 Participants n=5 Participants	251 Participants n=7 Participants	310 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	VADERA I n=223 Participants 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.
PHQ-9 Score at Baseline: VADERA I	5.2 scores on a scale Standard Deviation 4.0

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	VADERA I n=207 Participants 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.
PHQ-9 Score at Week 12 ± 2: VADERA I	4.8 scores on a scale Standard Deviation 4.2

PRIMARY outcome

Timeframe: Baseline

Population: Validation analysis set of VADERA I population. Number of participants analyzed = participants with BDI-II score assessment at 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.

Outcome measures

Outcome measures
Measure	VADERA I n=261 Participants 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.
BDI-II Score at Baseline: VADERA I	9.3 scores on a scale Standard Deviation 7.6

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	VADERA I n=215 Participants 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.
BDI-II Score at Week 12 ± 2: VADERA I	8.5 scores on a scale Standard Deviation 7.8

PRIMARY outcome

Timeframe: Baseline

Population: Validation analysis set of VADERA I population. Number of participants analyzed = participants with WHO-5 score assessment at 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.

Outcome measures

Outcome measures
Measure	VADERA I n=224 Participants 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.
WHO-5 Index at Baseline: VADERA I	61.1 scores on a scale Standard Deviation 23.6

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	VADERA I n=206 Participants 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.
WHO-5 Index at Week 12 ± 2: VADERA I	63.9 scores on a scale Standard Deviation 23.6

PRIMARY outcome

Timeframe: Baseline

Population: Validation analysis set of VADERA I population. Number of participants analyzed = participants with MADRS assessment at 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.

Outcome measures

Outcome measures
Measure	VADERA I n=259 Participants 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.
MADRS at Baseline: VADERA I	7.3 scores on a scale Standard Deviation 6.4

PRIMARY outcome

Timeframe: Week 12 ± 2

Population: Validation analysis set of VADERA I population. Number of participants analyzed = participants with MADRS assessment at specified time-point.

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.

Outcome measures

Outcome measures
Measure	VADERA I n=218 Participants 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.
MADRS at Week 12 ± 2: VADERA I	6.8 scores on a scale Standard Deviation 6.3

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	VADERA I n=975 Participants 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.
PHQ-9 Summary Score: VADERA II	6.0 scores on a scale Standard Deviation 4.7

PRIMARY outcome

Timeframe: Baseline

Population: Full analysis set of VADERA II population. Number of participants analyzed = participants with BDI-II summary score assessment at 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.

Outcome measures

Outcome measures
Measure	VADERA I n=971 Participants 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.
BDI-II Summary Score: VADERA II	10.1 scores on a scale Standard Deviation 8.8

PRIMARY outcome

Timeframe: Baseline

Population: Full analysis set of VADERA II population.

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.

Outcome measures

Outcome measures
Measure	VADERA I n=1004 Participants 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.
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 Interval 51.89 to 58.23
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 Interval 24.91 to 30.63
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 Interval 52.24 to 58.48

Adverse Events

VADERA I

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

VADERA II

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800-821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER