TriangleNCT03570749 · OUTCOME
Mean Change From Baseline in HADS Depression Score - Phase 3
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- LEAST_SQUARES_MEAN
- Unit
- score on a scale
- Interval / dispersion
- Standard Error
- Time frame
- Baseline, Week 36
What was measured
The HADS is a 14 item self-assessment scale that determines the levels of anxiety and depression that a patient is experiencing over the past week. The HADS utilizes a 4-point Likert scale (e.g., 0 to 3) for each question and is intended for ages 12 to 65 years. Scores for each domain (anxiety and depression) can range from 0 to 21, with higher scores indicating greater anxiety or depression. LS mean was calculated using an ANCOVA model which includes geographic region, duration of current episode at baseline (\<4 years vs. ≥4 years), treatment group and baseline score as fixed factors.
Analysis population: All randomized phase 3 participants with non-missing baseline and at least one post-baseline measurement who had evaluable data for this outcome measure. The method used to handle missing data will be mLOCF which used the most recent nonmissing postbaseline assessment.
Groups in this outcome
Placebo Phase 3
Participants received two placebo tablets administered orally QD.
2 mg Baricitinib Phase 3
Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
4 mg Baricitinib Phase 3
Participants received one 4 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
| Group | Source count |
|---|---|
| Placebo Phase 3 | 177 |
| 2 mg Baricitinib Phase 3 | 174 |
| 4 mg Baricitinib Phase 3 | 272 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo Phase 3 | 0.04 | 0.210 | Not reported | Not reported | Not reported |
| 2 mg Baricitinib Phase 3 | -0.38 | 0.213 | Not reported | Not reported | Not reported |
| 4 mg Baricitinib Phase 3 | -0.28 | 0.179 | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- -0.93
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.09
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.259
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.107
- param Type
- Mean Difference (Final Values)
- param Value
- -0.42
- statistical Method
- ANCOVA
- ci Lower Limit
- -0.78
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.14
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.234
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.174
- param Type
- Mean Difference (Final Values)
- param Value
- -0.32
- statistical Method
- ANCOVA
Complete source fields
- analyses
- ci Lower Limit
- -0.93
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.09
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.259
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.107
- param Type
- Mean Difference (Final Values)
- param Value
- -0.42
- statistical Method
- ANCOVA
- ci Lower Limit
- -0.78
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.14
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.234
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.174
- param Type
- Mean Difference (Final Values)
- param Value
- -0.32
- statistical Method
- ANCOVA
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.210
- value
- 0.04
- group Id
- OG001
- spread
- 0.213
- value
- -0.38
- group Id
- OG002
- spread
- 0.179
- value
- -0.28
- denoms
- counts
- group Id
- OG000
- value
- 177
- group Id
- OG001
- value
- 174
- group Id
- OG002
- value
- 272
- units
- Participants
- description
- The HADS is a 14 item self-assessment scale that determines the levels of anxiety and depression that a patient is experiencing over the past week. The HADS utilizes a 4-point Likert scale (e.g., 0 to 3) for each question and is intended for ages 12 to 65 years. Scores for each domain (anxiety and depression) can range from 0 to 21, with higher scores indicating greater anxiety or depression. LS mean was calculated using an ANCOVA model which includes geographic region, duration of current episode at baseline (\<4 years vs. ≥4 years), treatment group and baseline score as fixed factors.
- dispersion Type
- Standard Error
- groups
- description
- Participants received two placebo tablets administered orally QD.
- id
- OG000
- title
- Placebo Phase 3
- description
- Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
- id
- OG001
- title
- 2 mg Baricitinib Phase 3
- description
- Participants received one 4 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
- id
- OG002
- title
- 4 mg Baricitinib Phase 3
- param Type
- LEAST_SQUARES_MEAN
- population Description
- All randomized phase 3 participants with non-missing baseline and at least one post-baseline measurement who had evaluable data for this outcome measure. The method used to handle missing data will be mLOCF which used the most recent nonmissing postbaseline assessment.
- reporting Status
- POSTED
- time Frame
- Baseline, Week 36
- title
- Mean Change From Baseline in HADS Depression Score - Phase 3
- type
- SECONDARY
- unit Of Measure
- score on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice