Major Depressive Disorder
Conditions
Keywords
Major Depressive Disorder
Brief summary
The primary purpose of this study is to compare the long-term efficacy and safety of desvenlafaxine succinate sustained release versus placebo in adults with Major Depressive Disorder, using a randomized withdrawal design. Randomized withdrawal means that after receiving desvenlafaxine succinate sustained release for a predetermined period of time, subjects will be selected by chance to either continue receiving the study drug or to be withdrawn from the study drug and receive placebo for the remainder of their participation in the trial. Subjects will not know to which group they have been assigned. The study consists of an up to 14-day screening period followed by an 8-week open-label period in which subjects will knowingly receive 50 mg/day of desvenlafaxine succinate sustained release. Subjects who do not respond to treatment, demonstrating no significant change in their depressive symptoms, will be withdrawn from participation at the end of this period. Responding subjects will receive an additional 3 months of open-label desvenlafaxine succinate sustained release at the same dose. Subjects with stable response to treatment at the conclusion of this 3 month period will be randomized to either desvenlafaxine succinate sustained release at 50 mg/day or placebo in a blinded manner for an additional 6 months or until symptoms of depression return. Following discontinuation at any point after enrollment in the study, subjects will receive two weeks of follow-up monitoring, including one week of blinded taper with 25 mg/day of desvenlafaxine succinate sustained release treatment for any subjects who have been taking desvenlafaxine succinate sustained release prior to discontinuation. Subjects assigned to placebo will receive a blinded placebo taper. Following taper, subjects will be evaluated for one additional week to monitor safety.
Interventions
DRUGDesvenlafaxine succinate sustained release 50 mg
50 mg tablet, once daily. 5 months open-label duration for all enrolled subjects; additional 6 months double-blind duration for randomized subjects assigned to this arm.
DRUGDesvenlafaxine succinate sustained release 25 mg
25 mg tablet for taper, once daily for 1 week
DRUGPlacebo
Matching placebo tablet, once daily. 6 months double-blind duration for randomized subjects assigned to placebo.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult, outpatient with primary diagnosis of Major Depressive Disorder (depressive symptoms for at least 30 days prior to screening) * Hamilton Psychiatric Rating Scale for Depression (HAM-D 17) total score of \>= 20 * Clinical Global Impressions Scale-Severity (CGI-S) score of \>= 4.
Exclusion criteria
* Significant risk of suicide as assessed by clinician judgment, HAM-D17 and Columbia Suicide-Severity Rating Scale scores. * Past treatment with desvenlafaxine succinate sustained release. * Other eligibility criteria also apply.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Relapse Following Randomization to the Double-blind (DB) Phase: Estimated Probability (Percent) of Relapse at DB Day 185 | Double-blind phase Baseline (Study Day 140) up to DB Day 185 (Study Day 325) | Time to relapse analyzed using log-rank test; defined as Hamilton Psychiatric Scale for Depression-17 item score ≥16 at any time during DB phase, discontinuation for unsatisfactory response or efficacy (need for additional or alternate treatment for depression, investigator decision to remove participant for efficacy reasons, or failure to return if investigator determined related to efficacy), hospitalization for depression, suicide attempt, or suicide. Participants who relapsed after DB day 185 or completed DB therapy without relapse were considered as censored on DB day 185 (study day 325). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score in the Double-blind Phase | Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322) | CGI-S is a 7-point clinician rated scale to assess severity of participant's current illness state; range of 1 (normal - not ill at all) to 7 (among the most extremely ill). Higher score = more affected. Change from baseline mean=adjusted mean change calculated using mixed-effects model for repeated measures (MMRM). |
| Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score in the Double-blind Phase | Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322) | HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Nine items are scored on a 3 point scale (0=none/absent to 2=most severe) and 8 items are scored on a 5 point scale (0=none/absent to 4=most severe) for a maximum total score of 50; higher score indicates more depression. Change from baseline mean=adjusted mean change calculated using MMRM. |
| Change From Baseline in Hamilton Psychiatric Scale for Depression-6 Item (HAM-D6) Score in the Double-blind Phase | Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322) | HAM-D6 is a standardized, clinician-administered rating scale is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 is scored 0 to 2 (0=none/absent to 2=most severe) and all others are scored 0 to 4 (0=none/absent to 4=most severe). Total score ranges from 0 to 22; higher score indicates more depression. Change from baseline mean=adjusted mean change calculated using MMRM. |
| Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322) | CGI-I is a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. |
| Change From Baseline of Double-blind Phase in World Health Organization (Five-Item) Well-Being Index | Double-blind phase Baseline (Study Day 140), Week 14 (Study Day 238), Week 26 (Study Day 322) | WHO-5 evaluates positive psychological well-being during the past 2 weeks and consists of 5 questions (felt cheerful, in good spirits; felt calm, relaxed; felt active, vigorous; woke up fresh, rested; and daily life filled with things that are interesting) each rated on a 6-point Likert scale from 0 (not present) to 5 (constantly present). Total raw score ranged from 0 (worst possible quality of life) to 25 (best possible quality of life). Change from baseline mean=adjusted mean change calculated using MMRM. |
| Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Score in the Double-blind Phase | Double-blind phase Baseline (Study Day 140), Week 14 (Study Day 238), Week 26 (Study Day 322) | WPAI is a 6 question participant rated questionnaire to determine the degree to which depression affected work productivity while at work and affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher score indicated greater impairment and less productivity. |
| Number of Participants With Remission Based on Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score at Double-blind Phase Week 26 | Double-blind phase Week 26 (Study Day 322) | HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Nine items are scored on a 3 point scale (0=none/absent to 2=most severe) and 8 items are scored on a 5 point scale (0=none/absent to 4=most severe) for a maximum total score of 50; higher score indicates more depression. Remission defined as HAM-D17 total score ≤7. |
Countries
Canada, Chile, Colombia, Croatia, Estonia, Finland, France, Latvia, Lithuania, Poland, Romania, Slovakia, South Africa, United States
Participant flow
Pre-assignment details
1072 participants were screened, 874 were enrolled into Desvenlafaxine succinate sustained release (DVS SR) open-label 8-week response phase; 659 entered into 12-week open label stability phase. After 20 weeks of open-label treatment 548 subjects were randomized to the 6-month double-blind phase to receive either placebo or to continue with DVS SR.
Participants by arm
| Arm | Count |
|---|---|
| DVS SR 50 mg (Open-label Phase) DVS SR 50 mg PO QD for 20 weeks (Days 1 to 140). This included an 8-week response phase and for responders at Week 8, a 12-week stability phase. Participants who concluded open-label study or discontinued treatment received DVS SR 25 mg PO QD for 7-day taper period (All Enrolled Population). | 874 |
| Placebo (Double-blind Phase) Eligible participants from OL Phase were randomized in a 1:1 ratio to either Placebo or DVS SR in the DB Phase.
Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD (All Randomized Population). | 276 |
| DVS SR 50 mg (Double-blind Phase) Eligible participants from OL Phase were randomized in a 1:1 ratio to either Placebo or DVS SR in the DB Phase.
DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD (All Randomized Population). | 272 |
| Total | 1,422 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| DB Taper Phase / Post Study Follow Up | Adverse Event | 0 | 5 | 0 |
| DB Taper Phase / Post Study Follow Up | Failed to return | 0 | 5 | 4 |
| DB Taper Phase / Post Study Follow Up | Lost to Follow-up | 0 | 2 | 2 |
| DB Taper Phase / Post Study Follow Up | Other | 0 | 11 | 12 |
| DB Taper Phase / Post Study Follow Up | Physician Decision | 0 | 6 | 0 |
| DB Taper Phase / Post Study Follow Up | Protocol Violation | 0 | 4 | 1 |
| DB Taper Phase / Post Study Follow Up | Withdrawal by Subject | 0 | 8 | 11 |
| Double-blind (DB) Phase | Adverse Event | 0 | 7 | 2 |
| Double-blind (DB) Phase | Failed to return | 0 | 2 | 2 |
| Double-blind (DB) Phase | Lack of Efficacy | 0 | 67 | 33 |
| Double-blind (DB) Phase | Lost to Follow-up | 0 | 8 | 8 |
| Double-blind (DB) Phase | Other | 0 | 2 | 0 |
| Double-blind (DB) Phase | Protocol Violation | 0 | 8 | 5 |
| Double-blind (DB) Phase | Withdrawal by Subject | 0 | 6 | 12 |
| OL Taper Phase / OL Follow Up | Adverse Event | 28 | 0 | 0 |
| OL Taper Phase / OL Follow Up | Failed to return | 17 | 0 | 0 |
| OL Taper Phase / OL Follow Up | Lost to Follow-up | 8 | 0 | 0 |
| OL Taper Phase / OL Follow Up | Other | 30 | 0 | 0 |
| OL Taper Phase / OL Follow Up | Physician Decision | 10 | 0 | 0 |
| OL Taper Phase / OL Follow Up | Protocol Violation | 3 | 0 | 0 |
| OL Taper Phase / OL Follow Up | Withdrawal by Subject | 48 | 0 | 0 |
| Open-label Response (OLR) Phase | Adverse Event | 46 | 0 | 0 |
| Open-label Response (OLR) Phase | Failed to return | 6 | 0 | 0 |
| Open-label Response (OLR) Phase | Lack of Efficacy | 26 | 0 | 0 |
| Open-label Response (OLR) Phase | Lost to Follow-up | 16 | 0 | 0 |
| Open-label Response (OLR) Phase | Other | 1 | 0 | 0 |
| Open-label Response (OLR) Phase | Protocol Violation | 12 | 0 | 0 |
| Open-label Response (OLR) Phase | Withdrawal by Subject | 15 | 0 | 0 |
| Open-label Stability (OLS) Phase | Adverse Event | 22 | 0 | 0 |
| Open-label Stability (OLS) Phase | Failed to return | 3 | 0 | 0 |
| Open-label Stability (OLS) Phase | Lack of Efficacy | 16 | 0 | 0 |
| Open-label Stability (OLS) Phase | Lost to Follow-up | 9 | 0 | 0 |
| Open-label Stability (OLS) Phase | Other | 1 | 0 | 0 |
| Open-label Stability (OLS) Phase | Protocol Violation | 13 | 0 | 0 |
| Open-label Stability (OLS) Phase | Withdrawal by Subject | 19 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | DVS SR 50 mg (Open-label Phase) | DVS SR 50 mg (Double-blind Phase) | Placebo (Double-blind Phase) |
|---|---|---|---|---|
| Age, Continuous | 44.98 years STANDARD_DEVIATION 13.25 | 44.98 years STANDARD_DEVIATION 13.25 | NA years | NA years |
| Gender Female | 608 participants | 608 participants | 0 participants | 0 participants |
| Gender Male | 266 participants | 266 participants | 0 participants | 0 participants |
| Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Total Score | 4.64 scores on a scale STANDARD_DEVIATION 2.99 | NA scores on a scale | 4.69 scores on a scale STANDARD_DEVIATION 2.97 | 4.58 scores on a scale STANDARD_DEVIATION 3.02 |
| Number of participants per categorical score on Clinical Global Impression-Improvement (CGI-I) scale 1=very much improved | 462 participants | 0 participants | 223 participants | 239 participants |
| Number of participants per categorical score on Clinical Global Impression-Improvement (CGI-I) scale 2=much improved | 85 participants | 0 participants | 49 participants | 36 participants |
| Number of participants per categorical score on Clinical Global Impression-Improvement (CGI-I) scale 3=minimally improved | 1 participants | 0 participants | 0 participants | 1 participants |
| Number of participants per categorical score on Clinical Global Impression-Improvement (CGI-I) scale 4=no change | 0 participants | 0 participants | 0 participants | 0 participants |
| Number of participants per categorical score on Clinical Global Impression-Improvement (CGI-I) scale 5=minimally worse | 0 participants | 0 participants | 0 participants | 0 participants |
| Number of participants per categorical score on Clinical Global Impression-Improvement (CGI-I) scale 6=much worse | 0 participants | 0 participants | 0 participants | 0 participants |
| Number of participants per categorical score on Clinical Global Impression-Improvement (CGI-I) scale 7=very much worse | 0 participants | 0 participants | 0 participants | 0 participants |
| Number of participants with remission based on HAM-D17 score Remission=No | 98 participants | 0 participants | 52 participants | 46 participants |
| Number of participants with remission based on HAM-D17 score Remission=Yes | 450 participants | 0 participants | 220 participants | 230 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 609 / 874 | 36 / 659 | 8 / 326 | 81 / 276 | 55 / 272 | 14 / 276 | 23 / 272 |
| serious Total, serious adverse events | 9 / 874 | 6 / 659 | 4 / 326 | 7 / 276 | 8 / 272 | 1 / 276 | 1 / 272 |
Outcome results
Primary
Time to Relapse Following Randomization to the Double-blind (DB) Phase: Estimated Probability (Percent) of Relapse at DB Day 185
Time to relapse analyzed using log-rank test; defined as Hamilton Psychiatric Scale for Depression-17 item score ≥16 at any time during DB phase, discontinuation for unsatisfactory response or efficacy (need for additional or alternate treatment for depression, investigator decision to remove participant for efficacy reasons, or failure to return if investigator determined related to efficacy), hospitalization for depression, suicide attempt, or suicide. Participants who relapsed after DB day 185 or completed DB therapy without relapse were considered as censored on DB day 185 (study day 325).
Time frame: Double-blind phase Baseline (Study Day 140) up to DB Day 185 (Study Day 325)
Population: All Randomized population: all participants randomly assigned to the Double-blind treatment phase of the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Time to Relapse Following Randomization to the Double-blind (DB) Phase: Estimated Probability (Percent) of Relapse at DB Day 185 | 30.2 percent estimated probability |
| DVS SR 50 mg | Time to Relapse Following Randomization to the Double-blind (DB) Phase: Estimated Probability (Percent) of Relapse at DB Day 185 | 14.3 percent estimated probability |
p-value: <0.001Log Rank
Secondary
Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score in the Double-blind Phase
CGI-S is a 7-point clinician rated scale to assess severity of participant's current illness state; range of 1 (normal - not ill at all) to 7 (among the most extremely ill). Higher score = more affected. Change from baseline mean=adjusted mean change calculated using mixed-effects model for repeated measures (MMRM).
Time frame: Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322)
Population: All Randomized population. N=number of participants with analyzable data at observation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score in the Double-blind Phase | Change from Baseline at DB Week 3 | 0.21 scores on a scale | Standard Error 0.04 |
| Placebo | Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score in the Double-blind Phase | Change from Baseline at DB Week 10 | 0.39 scores on a scale | Standard Error 0.06 |
| Placebo | Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score in the Double-blind Phase | Change from Baseline at DB Week 2 | 0.18 scores on a scale | Standard Error 0.04 |
| Placebo | Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score in the Double-blind Phase | Change from Baseline at DB Week 14 | 0.38 scores on a scale | Standard Error 0.05 |
| Placebo | Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score in the Double-blind Phase | Change from Baseline at DB Week 4 | 0.23 scores on a scale | Standard Error 0.05 |
| Placebo | Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score in the Double-blind Phase | Change from Baseline at DB Week 18 | 0.42 scores on a scale | Standard Error 0.06 |
| Placebo | Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score in the Double-blind Phase | Change from Baseline at DB Week 22 | 0.56 scores on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score in the Double-blind Phase | Change from Baseline at DB Week 1 | 0.03 scores on a scale | Standard Error 0.03 |
| Placebo | Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score in the Double-blind Phase | Change from Baseline at DB Week 26 | 0.53 scores on a scale | Standard Error 0.06 |
| Placebo | Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score in the Double-blind Phase | Change from Baseline at DB Week 6 | 0.32 scores on a scale | Standard Error 0.05 |
| DVS SR 50 mg | Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score in the Double-blind Phase | Change from Baseline at DB Week 26 | 0.09 scores on a scale | Standard Error 0.06 |
| DVS SR 50 mg | Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score in the Double-blind Phase | Change from Baseline at DB Week 1 | 0.03 scores on a scale | Standard Error 0.03 |
| DVS SR 50 mg | Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score in the Double-blind Phase | Change from Baseline at DB Week 2 | 0.09 scores on a scale | Standard Error 0.04 |
| DVS SR 50 mg | Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score in the Double-blind Phase | Change from Baseline at DB Week 3 | 0.07 scores on a scale | Standard Error 0.04 |
| DVS SR 50 mg | Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score in the Double-blind Phase | Change from Baseline at DB Week 4 | 0.06 scores on a scale | Standard Error 0.05 |
| DVS SR 50 mg | Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score in the Double-blind Phase | Change from Baseline at DB Week 6 | 0.06 scores on a scale | Standard Error 0.05 |
| DVS SR 50 mg | Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score in the Double-blind Phase | Change from Baseline at DB Week 10 | 0.11 scores on a scale | Standard Error 0.06 |
| DVS SR 50 mg | Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score in the Double-blind Phase | Change from Baseline at DB Week 14 | 0.05 scores on a scale | Standard Error 0.05 |
| DVS SR 50 mg | Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score in the Double-blind Phase | Change from Baseline at DB Week 22 | 0.13 scores on a scale | Standard Error 0.07 |
| DVS SR 50 mg | Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score in the Double-blind Phase | Change from Baseline at DB Week 18 | 0.09 scores on a scale | Standard Error 0.06 |
Comparison: Adjusted difference from placebo: Week 26p-value: <0.00195% CI: [0.28, 0.61]Mixed Models Analysis
Comparison: Adjusted difference from placebo: Week 1p-value: 0.962795% CI: [-0.09, 0.08]Mixed Models Analysis
Comparison: Adjusted difference from placebo: Week 2p-value: 0.104695% CI: [-0.02, 0.21]Mixed Models Analysis
Comparison: Adjusted difference from placebo: Week 3p-value: 0.022895% CI: [0.02, 0.25]Mixed Models Analysis
Comparison: Adjusted difference from placebo: Week 4p-value: 0.006495% CI: [0.05, 0.29]Mixed Models Analysis
Comparison: Adjusted difference from placebo: Week 6p-value: <0.00195% CI: [0.11, 0.39]Mixed Models Analysis
Comparison: Adjusted difference from placebo: Week 10p-value: <0.00195% CI: [0.12, 0.43]Mixed Models Analysis
Comparison: Adjusted difference from placebo: Week 14p-value: <0.00195% CI: [0.19, 0.47]Mixed Models Analysis
Comparison: Adjusted difference from placebo: Week 18p-value: <0.00195% CI: [0.17, 0.49]Mixed Models Analysis
Comparison: Adjusted difference from placebo: Week 22p-value: <0.00195% CI: [0.25, 0.62]Mixed Models Analysis
Secondary
Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score in the Double-blind Phase
HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Nine items are scored on a 3 point scale (0=none/absent to 2=most severe) and 8 items are scored on a 5 point scale (0=none/absent to 4=most severe) for a maximum total score of 50; higher score indicates more depression. Change from baseline mean=adjusted mean change calculated using MMRM.
Time frame: Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322)
Population: All Randomized population. N=number of participants with analyzable data at observation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score in the Double-blind Phase | Change from Baseline at DB Week 1 | 0.28 scores on a scale | Standard Error 0.17 |
| Placebo | Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score in the Double-blind Phase | Change from Baseline at DB Week 2 | 1.40 scores on a scale | Standard Error 0.24 |
| Placebo | Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score in the Double-blind Phase | Change from Baseline at DB Week 3 | 1.32 scores on a scale | Standard Error 0.22 |
| Placebo | Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score in the Double-blind Phase | Change from Baseline at DB Week 4 | 1.50 scores on a scale | Standard Error 0.24 |
| Placebo | Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score in the Double-blind Phase | Change from Baseline at DB Week 6 | 1.94 scores on a scale | Standard Error 0.28 |
| Placebo | Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score in the Double-blind Phase | Change from Baseline at DB Week 10 | 2.37 scores on a scale | Standard Error 0.32 |
| Placebo | Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score in the Double-blind Phase | Change from Baseline at DB Week 14 | 2.66 scores on a scale | Standard Error 0.3 |
| Placebo | Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score in the Double-blind Phase | Change from Baseline at DB Week 18 | 2.51 scores on a scale | Standard Error 0.33 |
| Placebo | Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score in the Double-blind Phase | Change from Baseline at DB Week 22 | 3.22 scores on a scale | Standard Error 0.37 |
| Placebo | Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score in the Double-blind Phase | Change from Baseline at DB Week 26 | 3.12 scores on a scale | Standard Error 0.36 |
| DVS SR 50 mg | Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score in the Double-blind Phase | Change from Baseline at DB Week 18 | 0.56 scores on a scale | Standard Error 0.32 |
| DVS SR 50 mg | Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score in the Double-blind Phase | Change from Baseline at DB Week 1 | 0.25 scores on a scale | Standard Error 0.17 |
| DVS SR 50 mg | Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score in the Double-blind Phase | Change from Baseline at DB Week 10 | 0.69 scores on a scale | Standard Error 0.31 |
| DVS SR 50 mg | Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score in the Double-blind Phase | Change from Baseline at DB Week 2 | 0.53 scores on a scale | Standard Error 0.24 |
| DVS SR 50 mg | Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score in the Double-blind Phase | Change from Baseline at DB Week 26 | 0.77 scores on a scale | Standard Error 0.34 |
| DVS SR 50 mg | Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score in the Double-blind Phase | Change from Baseline at DB Week 3 | 0.45 scores on a scale | Standard Error 0.23 |
| DVS SR 50 mg | Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score in the Double-blind Phase | Change from Baseline at DB Week 14 | 0.62 scores on a scale | Standard Error 0.3 |
| DVS SR 50 mg | Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score in the Double-blind Phase | Change from Baseline at DB Week 4 | 0.11 scores on a scale | Standard Error 0.24 |
| DVS SR 50 mg | Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score in the Double-blind Phase | Change from Baseline at DB Week 22 | 0.92 scores on a scale | Standard Error 0.36 |
| DVS SR 50 mg | Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score in the Double-blind Phase | Change from Baseline at DB Week 6 | 0.31 scores on a scale | Standard Error 0.28 |
Comparison: Adjusted difference from placebo: Week 1p-value: 0.885395% CI: [-0.41, 0.47]Mixed Models Analysis
Comparison: Adjusted difference from placebo: Week 2p-value: 0.008195% CI: [0.23, 1.52]Mixed Models Analysis
Comparison: Adjusted difference from placebo: Week 3p-value: 0.003895% CI: [0.28, 1.47]Mixed Models Analysis
Comparison: Adjusted difference from placebo: Week 4p-value: <0.00195% CI: [0.76, 2.03]Mixed Models Analysis
Comparison: Adjusted difference from placebo: Week 6p-value: <0.00195% CI: [0.86, 2.39]Mixed Models Analysis
Comparison: Adjusted difference from placebo: Week 10p-value: <0.00195% CI: [0.83, 2.54]Mixed Models Analysis
Comparison: Adjusted difference from placebo: Week 14p-value: <0.00195% CI: [1.23, 2.86]Mixed Models Analysis
Comparison: Adjusted difference from placebo: Week 18p-value: <0.00195% CI: [1.06, 2.84]Mixed Models Analysis
Comparison: Adjusted difference from placebo: Week 22p-value: <0.00195% CI: [1.31, 3.3]Mixed Models Analysis
Comparison: Adjusted difference from placebo: Week 26p-value: <0.00195% CI: [1.39, 3.32]Mixed Models Analysis
Secondary
Change From Baseline in Hamilton Psychiatric Scale for Depression-6 Item (HAM-D6) Score in the Double-blind Phase
HAM-D6 is a standardized, clinician-administered rating scale is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 is scored 0 to 2 (0=none/absent to 2=most severe) and all others are scored 0 to 4 (0=none/absent to 4=most severe). Total score ranges from 0 to 22; higher score indicates more depression. Change from baseline mean=adjusted mean change calculated using MMRM.
Time frame: Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322)
Population: All Randomized population. N=number of participants with analyzable data at observation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Hamilton Psychiatric Scale for Depression-6 Item (HAM-D6) Score in the Double-blind Phase | Change from baseline at DB Week1 | 0.03 scores on a scale | Standard Error 0.1 |
| Placebo | Change From Baseline in Hamilton Psychiatric Scale for Depression-6 Item (HAM-D6) Score in the Double-blind Phase | Change from baseline at DB Week 2 | 0.66 scores on a scale | Standard Error 0.14 |
| Placebo | Change From Baseline in Hamilton Psychiatric Scale for Depression-6 Item (HAM-D6) Score in the Double-blind Phase | Change from baseline at DB Week 3 | 0.72 scores on a scale | Standard Error 0.14 |
| Placebo | Change From Baseline in Hamilton Psychiatric Scale for Depression-6 Item (HAM-D6) Score in the Double-blind Phase | Change from baseline at DB Week 4 | 0.92 scores on a scale | Standard Error 0.15 |
| Placebo | Change From Baseline in Hamilton Psychiatric Scale for Depression-6 Item (HAM-D6) Score in the Double-blind Phase | Change from baseline at DB Week 6 | 1.04 scores on a scale | Standard Error 0.17 |
| Placebo | Change From Baseline in Hamilton Psychiatric Scale for Depression-6 Item (HAM-D6) Score in the Double-blind Phase | Change from baseline at DB Week 10 | 1.41 scores on a scale | Standard Error 0.19 |
| Placebo | Change From Baseline in Hamilton Psychiatric Scale for Depression-6 Item (HAM-D6) Score in the Double-blind Phase | Change from baseline at DB Week 14 | 1.47 scores on a scale | Standard Error 0.17 |
| Placebo | Change From Baseline in Hamilton Psychiatric Scale for Depression-6 Item (HAM-D6) Score in the Double-blind Phase | Change from baseline at DB Week 18 | 1.51 scores on a scale | Standard Error 0.2 |
| Placebo | Change From Baseline in Hamilton Psychiatric Scale for Depression-6 Item (HAM-D6) Score in the Double-blind Phase | Change from baseline at DB Week 22 | 1.68 scores on a scale | Standard Error 0.2 |
| Placebo | Change From Baseline in Hamilton Psychiatric Scale for Depression-6 Item (HAM-D6) Score in the Double-blind Phase | Change from baseline at DB Week 26 | 1.53 scores on a scale | Standard Error 0.2 |
| DVS SR 50 mg | Change From Baseline in Hamilton Psychiatric Scale for Depression-6 Item (HAM-D6) Score in the Double-blind Phase | Change from baseline at DB Week 18 | 0.21 scores on a scale | Standard Error 0.19 |
| DVS SR 50 mg | Change From Baseline in Hamilton Psychiatric Scale for Depression-6 Item (HAM-D6) Score in the Double-blind Phase | Change from baseline at DB Week1 | 0.01 scores on a scale | Standard Error 0.1 |
| DVS SR 50 mg | Change From Baseline in Hamilton Psychiatric Scale for Depression-6 Item (HAM-D6) Score in the Double-blind Phase | Change from baseline at DB Week 10 | 0.33 scores on a scale | Standard Error 0.18 |
| DVS SR 50 mg | Change From Baseline in Hamilton Psychiatric Scale for Depression-6 Item (HAM-D6) Score in the Double-blind Phase | Change from baseline at DB Week 2 | 0.13 scores on a scale | Standard Error 0.14 |
| DVS SR 50 mg | Change From Baseline in Hamilton Psychiatric Scale for Depression-6 Item (HAM-D6) Score in the Double-blind Phase | Change from baseline at DB Week 26 | 0.26 scores on a scale | Standard Error 0.19 |
| DVS SR 50 mg | Change From Baseline in Hamilton Psychiatric Scale for Depression-6 Item (HAM-D6) Score in the Double-blind Phase | Change from baseline at DB Week 3 | 0.14 scores on a scale | Standard Error 0.14 |
| DVS SR 50 mg | Change From Baseline in Hamilton Psychiatric Scale for Depression-6 Item (HAM-D6) Score in the Double-blind Phase | Change from baseline at DB Week 14 | 0.34 scores on a scale | Standard Error 0.17 |
| DVS SR 50 mg | Change From Baseline in Hamilton Psychiatric Scale for Depression-6 Item (HAM-D6) Score in the Double-blind Phase | Change from baseline at DB Week 4 | 0.03 scores on a scale | Standard Error 0.15 |
| DVS SR 50 mg | Change From Baseline in Hamilton Psychiatric Scale for Depression-6 Item (HAM-D6) Score in the Double-blind Phase | Change from baseline at DB Week 22 | 0.45 scores on a scale | Standard Error 0.19 |
| DVS SR 50 mg | Change From Baseline in Hamilton Psychiatric Scale for Depression-6 Item (HAM-D6) Score in the Double-blind Phase | Change from baseline at DB Week 6 | 0.16 scores on a scale | Standard Error 0.16 |
Comparison: Adjusted difference from placebo: Week 1p-value: 0.914295% CI: [-0.24, 0.27]Mixed Models Analysis
Comparison: Adjusted difference from placebo: Week 2p-value: 0.006995% CI: [0.15, 0.91]Mixed Models Analysis
Comparison: Adjusted difference from placebo: Week 3p-value: 0.002395% CI: [0.21, 0.95]Mixed Models Analysis
Comparison: Adjusted difference from placebo: Week 4p-value: <0.00195% CI: [0.49, 1.28]Mixed Models Analysis
Comparison: Adjusted difference from placebo: Week 6p-value: <0.00195% CI: [0.43, 1.32]Mixed Models Analysis
Comparison: Adjusted difference from placebo: Week 10p-value: <0.00195% CI: [0.58, 1.58]Mixed Models Analysis
Comparison: Adjusted difference from placebo: Week 14p-value: <0.00195% CI: [0.66, 1.58]Mixed Models Analysis
Comparison: Adjusted difference from placebo: Week 18p-value: <0.00195% CI: [0.76, 1.83]Mixed Models Analysis
Comparison: Adjusted difference from placebo: Week 22p-value: <0.00195% CI: [0.7, 1.76]Mixed Models Analysis
Comparison: Adjusted difference from placebo: Week 26p-value: <0.00195% CI: [0.75, 1.79]Mixed Models Analysis
Secondary
Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Score in the Double-blind Phase
WPAI is a 6 question participant rated questionnaire to determine the degree to which depression affected work productivity while at work and affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher score indicated greater impairment and less productivity.
Time frame: Double-blind phase Baseline (Study Day 140), Week 14 (Study Day 238), Week 26 (Study Day 322)
Population: All Randomized population. Change from baseline (Bsl) mean=adjusted mean change calculated using MMRM.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Score in the Double-blind Phase | Change from Bsl at DB Week 14: Absenteeism | 1.64 scores on a scale | Standard Error 1.72 |
| Placebo | Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Score in the Double-blind Phase | Change from Bsl at DB Week 14: Presenteeism | 9.35 scores on a scale | Standard Error 2.3 |
| Placebo | Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Score in the Double-blind Phase | Change from Bsl DB Week 14: Work productivity loss | 9.66 scores on a scale | Standard Error 2.48 |
| Placebo | Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Score in the Double-blind Phase | Change from Bsl at DB Week 14: Activity impairment | 11.02 scores on a scale | Standard Error 1.62 |
| Placebo | Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Score in the Double-blind Phase | Change from Bsl at DB Week 26: Absenteeism | 0.43 scores on a scale | Standard Error 2.05 |
| Placebo | Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Score in the Double-blind Phase | Change from Bsl at DB Week 26: Presenteeism | 7.75 scores on a scale | Standard Error 2.35 |
| Placebo | Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Score in the Double-blind Phase | Change from Bsl DB Week 26: Work productivity loss | 8.47 scores on a scale | Standard Error 2.56 |
| Placebo | Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Score in the Double-blind Phase | Change from Bsl at DB Week 26: Activity impairment | 9.67 scores on a scale | Standard Error 1.75 |
| DVS SR 50 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Score in the Double-blind Phase | Change from Bsl at DB Week 26: Activity impairment | 2.05 scores on a scale | Standard Error 1.69 |
| DVS SR 50 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Score in the Double-blind Phase | Change from Bsl at DB Week 14: Absenteeism | 0.62 scores on a scale | Standard Error 1.87 |
| DVS SR 50 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Score in the Double-blind Phase | Change from Bsl at DB Week 26: Absenteeism | 0.77 scores on a scale | Standard Error 2.08 |
| DVS SR 50 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Score in the Double-blind Phase | Change from Bsl at DB Week 14: Presenteeism | 2.44 scores on a scale | Standard Error 2.55 |
| DVS SR 50 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Score in the Double-blind Phase | Change from Bsl DB Week 26: Work productivity loss | -0.00 scores on a scale | Standard Error 2.63 |
| DVS SR 50 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Score in the Double-blind Phase | Change from Bsl DB Week 14: Work productivity loss | 2.19 scores on a scale | Standard Error 2.75 |
| DVS SR 50 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Score in the Double-blind Phase | Change from Bsl at DB Week 26: Presenteeism | -0.49 scores on a scale | Standard Error 2.41 |
| DVS SR 50 mg | Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Score in the Double-blind Phase | Change from Bsl at DB Week 14: Activity impairment | 3.45 scores on a scale | Standard Error 1.66 |
Comparison: Adjusted difference from placebo: Week 14 Absenteeismp-value: 0.677295% CI: [-3.82, 5.87]Mixed Models Analysis
Comparison: Adjusted difference from placebo: Week 26 Absenteeismp-value: 0.905995% CI: [-5.91, 5.24]Mixed Models Analysis
Comparison: Adjusted difference from placebo: Week 14 Presenteeismp-value: 0.041495% CI: [0.27, 13.55]Mixed Models Analysis
Comparison: Adjusted difference from placebo: Week 26 Presenteeismp-value: 0.012995% CI: [1.77, 14.71]Mixed Models Analysis
Comparison: Adjusted difference from placebo: Week 14 Work Productivity Lossp-value: 0.040295% CI: [0.34, 14.61]Mixed Models Analysis
Comparison: Adjusted difference from placebo: Week 26 Work Productivity Lossp-value: 0.018795% CI: [1.43, 15.53]Mixed Models Analysis
Comparison: Adjusted difference from placebo: Week 14 Activity Impairmentp-value: <0.00195% CI: [3.33, 11.8]Mixed Models Analysis
Comparison: Adjusted difference from placebo: Week 26 Activity Impairmentp-value: <0.00195% CI: [3.14, 12.1]Mixed Models Analysis
Secondary
Change From Baseline of Double-blind Phase in World Health Organization (Five-Item) Well-Being Index
WHO-5 evaluates positive psychological well-being during the past 2 weeks and consists of 5 questions (felt cheerful, in good spirits; felt calm, relaxed; felt active, vigorous; woke up fresh, rested; and daily life filled with things that are interesting) each rated on a 6-point Likert scale from 0 (not present) to 5 (constantly present). Total raw score ranged from 0 (worst possible quality of life) to 25 (best possible quality of life). Change from baseline mean=adjusted mean change calculated using MMRM.
Time frame: Double-blind phase Baseline (Study Day 140), Week 14 (Study Day 238), Week 26 (Study Day 322)
Population: All Randomized population. N=number of participants with analyzable data at observation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline of Double-blind Phase in World Health Organization (Five-Item) Well-Being Index | Change from baseline at DB Week 14 | -2.51 scores on a scale | Standard Error 0.35 |
| Placebo | Change From Baseline of Double-blind Phase in World Health Organization (Five-Item) Well-Being Index | Change from baseline at DB Week 26 | -2.36 scores on a scale | Standard Error 0.38 |
| DVS SR 50 mg | Change From Baseline of Double-blind Phase in World Health Organization (Five-Item) Well-Being Index | Change from baseline at DB Week 14 | -0.38 scores on a scale | Standard Error 2.36 |
| DVS SR 50 mg | Change From Baseline of Double-blind Phase in World Health Organization (Five-Item) Well-Being Index | Change from baseline at DB Week 26 | -0.04 scores on a scale | Standard Error 0.37 |
Comparison: Adjusted difference from placebo: Week 14p-value: <0.00195% CI: [-3.03, -1.24]Mixed Models Analysis
Comparison: Adjusted difference from placebo: Week 26p-value: <0.00195% CI: [-3.29, -1.34]Mixed Models Analysis
Secondary
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
CGI-I is a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.
Time frame: Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322)
Population: All Randomized population. N=number of participants with analyzable data at observation (Observed Cases).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 10: 1=very much improved | 3 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 3: 5=minimally worse | 45 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 10: 2=much improved | 4 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 1: 6=much worse | 2 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 10: 3=minimally improved | 19 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 3: 6=much worse | 6 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 10: 4=no change | 140 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 2: 4=no change | 183 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 10: 5=minimally worse | 46 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 3: 7=very much worse | 0 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 10: 6=much worse | 9 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 1: 4=no change | 227 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 10: 7=very much worse | 1 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 4: 1=very much improved | 5 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 14: 1=very much improved | 3 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 2: 5=minimally worse | 32 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 14: 2=much improved | 5 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 4: 2=much improved | 6 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 14: 3=minimally improved | 16 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 1: 7=very much worse | 0 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 14: 4=no change | 124 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 4: 3=minimally improved | 20 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 14: 5=minimally worse | 49 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 2: 6=much worse | 15 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 14: 6=much worse | 10 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 4: 4=no change | 169 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 14: 7=very much worse | 0 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 1: 3=minimally improved | 12 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 18: 1=very much improved | 6 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 4: 5=minimally worse | 39 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 18: 2=much improved | 6 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 2: 7=very much worse | 0 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 18: 3=minimally improved | 12 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 4: 6=much worse | 6 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 18: 4=no change | 117 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 2: 1=very much improved | 7 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 18: 5=minimally worse | 39 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 4: 7=very much worse | 1 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 18: 6=much worse | 12 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 3: 1=very much improved | 5 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 18: 7=very much worse | 0 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 6: 1=very much improved | 6 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 22: 1=very much improved | 7 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 1: 5=minimally worse | 16 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 22: 2=much improved | 4 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 6: 2=much improved | 5 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 22: 3=minimally improved | 13 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 3: 2=much improved | 5 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 22: 4=no change | 116 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 6: 3=minimally improved | 20 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 22: 5=minimally worse | 30 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 2: 2=much improved | 5 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 22: 6=much worse | 13 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 6: 4=no change | 153 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 22: 7=very much worse | 1 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 3: 3=minimally improved | 17 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 26: 1=very much improved | 7 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 6: 5=minimally worse | 40 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 26: 2=much improved | 7 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 1: 2=much improved | 1 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 26: 3=minimally improved | 13 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 6: 6=much worse | 14 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 26: 4=no change | 105 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 3: 4=no change | 169 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 26: 5=minimally worse | 31 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 6: 7=very much worse | 0 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 26: 6=much worse | 10 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 2: 3=minimally improved | 15 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 26: 7=very much worse | 1 participants |
| Placebo | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 1: 1=very much improved | 9 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 26: 7=very much worse | 0 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 1: 1=very much improved | 3 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 1: 2=much improved | 3 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 1: 3=minimally improved | 19 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 1: 4=no change | 212 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 1: 5=minimally worse | 20 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 1: 6=much worse | 3 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 1: 7=very much worse | 1 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 2: 1=very much improved | 3 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 2: 2=much improved | 6 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 2: 3=minimally improved | 24 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 2: 4=no change | 197 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 2: 5=minimally worse | 25 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 2: 6=much worse | 4 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 2: 7=very much worse | 0 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 3: 1=very much improved | 6 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 3: 2=much improved | 8 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 3: 3=minimally improved | 27 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 3: 4=no change | 185 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 3: 5=minimally worse | 24 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 3: 6=much worse | 2 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 3: 7=very much worse | 0 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 4: 1=very much improved | 8 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 4: 2=much improved | 7 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 4: 3=minimally improved | 28 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 4: 4=no change | 181 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 4: 5=minimally worse | 20 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 4: 6=much worse | 2 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 4: 7=very much worse | 1 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 6: 1=very much improved | 9 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 6: 2=much improved | 11 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 6: 3=minimally improved | 31 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 6: 4=no change | 174 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 6: 5=minimally worse | 16 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 6: 6=much worse | 6 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 6: 7=very much worse | 0 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 10: 1=very much improved | 7 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 10: 2=much improved | 9 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 10: 3=minimally improved | 28 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 10: 4=no change | 161 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 10: 5=minimally worse | 28 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 10: 6=much worse | 8 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 10: 7=very much worse | 1 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 14: 1=very much improved | 4 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 14: 2=much improved | 10 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 14: 3=minimally improved | 29 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 14: 4=no change | 159 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 14: 5=minimally worse | 25 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 14: 6=much worse | 3 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 14: 7=very much worse | 0 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 18: 1=very much improved | 7 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 18: 2=much improved | 6 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 18: 3=minimally improved | 28 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 18: 4=no change | 151 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 18: 5=minimally worse | 24 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 18: 6=much worse | 6 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 18: 7=very much worse | 1 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 22: 1=very much improved | 8 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 22: 2=much improved | 6 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 22: 3=minimally improved | 29 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 22: 4=no change | 139 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 22: 5=minimally worse | 28 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 22: 6=much worse | 5 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 22: 7=very much worse | 0 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 26: 1=very much improved | 9 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 26: 2=much improved | 10 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 26: 3=minimally improved | 29 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 26: 4=no change | 135 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 26: 5=minimally worse | 22 participants |
| DVS SR 50 mg | Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale | DB Week 26: 6=much worse | 5 participants |
Secondary
Number of Participants With Remission Based on Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score at Double-blind Phase Week 26
HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Nine items are scored on a 3 point scale (0=none/absent to 2=most severe) and 8 items are scored on a 5 point scale (0=none/absent to 4=most severe) for a maximum total score of 50; higher score indicates more depression. Remission defined as HAM-D17 total score ≤7.
Time frame: Double-blind phase Week 26 (Study Day 322)
Population: All Randomized population. N=number of participants with analyzable data at observation based on Last Observation Carried Forward (LOCF).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Remission Based on Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score at Double-blind Phase Week 26 | 148 participants |
| DVS SR 50 mg | Number of Participants With Remission Based on Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score at Double-blind Phase Week 26 | 201 participants |
Comparison: Wald 95% CI for adjusted odds ratio.p-value: <0.000195% CI: [1.93, 4.2]Regression, Logistic