Major Depressive Disorder
Conditions
Brief summary
A multicenter, 8-week study to evaluate the efficacy of 2 doses (50 and 100 mg/day) of desvenlafaxine succinate sustained-release (DVS SR) versus placebo in adult outpatients with major depressive disorder.
Interventions
DRUGdesvenlafaxine succinate sustained-release 50 mg/day
50 mg tablets of DVS SR taken orally once daily for 8 weeks; 1 week of placebo taper
DRUGdesvenlafaxine succinate sustained-release 100 mg/day
100 mg tablets of DVS SR taken orally once daily for 8 weeks (which includes 1 week of titration at 50 mg/day); 1 week of taper at 50 mg/day
DRUGplacebo
50 mg and 100 mg placebo matching tablets taken orally once daily for 8 weeks; 1 week of placebo taper
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
* Male or female outpatients aged 18 years or older who are fluent in written and spoken English. * A primary diagnosis of MDD based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM- IV-TR), single or recurrent episode, without psychotic features. * A HAM-D17 total score ≥20 at the screening and baseline (study day -1) visits and no more than a 4-point improvement from screening to baseline.
Exclusion criteria
* Significant risk of suicide based on clinical judgment. * Current (within 12 months before baseline) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder. * Current generalized anxiety disorder, panic disorder, or social anxiety disorder. * History or current evidence of gastrointestinal disease known to interfere with the absorption or excretion of drugs or a history of surgery known to interfere with the absorption or excretion of drugs. * Any unstable hepatic, renal, pulmonary, cardiovascular, ophthalmologic, neurologic, or other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8 | Baseline to Week 8 (final on-therapy) | 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). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. Change from baseline: score at observation minus score at baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline on the Clinical Global Impression-Severity Score (CGI-S) | Baseline to Week 8 (final on-therapy) | CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = worse state. |
| Change From Baseline on the Clinical Global Impression-Severity (CGI-S) Score | Baseline to Week 8 (final on-therapy) | CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = worse state. |
| Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I) | Baseline to Week 8 (final on-therapy) | CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Higher score = worse outcome. |
| Hamilton Rating Scale for Depression, 17-item (HAM-D17) Remission Rate | Baseline to week 8 (final on-therapy) | 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). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) total score of ≤ 7. |
| Change From Baseline on the Arizona Sexual Experiences (ASEX) Scale Total Score | Baseline to Week 8 (final on-therapy) | The ASEX scale has 5 items to assess sexual functioning with a 1-week recall period. The 5 items assess sex drive, ease of arousal, ease of erection/lubrication, ease of orgasm and orgasm satisfaction. Subjects were encouraged to complete all 5 items regardless of sexual activity during the past week. However, all analyses utilized only the data for the visits where the presence of sexual activity was indicated. Each individual score ranged from 1 to 6; the total score (based on the sum of the individual items) ranged from 5 to 30; higher scores indicated worse sexual function. |
| Hamilton Rating Scale for Depression, 17-item (HAM-D17) Response Rate | Baseline to Week 8 (final on-therapy) | 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). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. A response is defined as ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression (HAM-D17) total score. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited in the United States from October 2011 to May 2012.
Pre-assignment details
Subjects were screened up to 2 weeks.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper. | 300 |
| DVS SR 50 mg Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper. | 300 |
| DVS SR 100 mg Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper. | 309 |
| Total | 909 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 7 | 10 | 16 |
| Overall Study | Did not take study drug | 6 | 6 | 3 |
| Overall Study | Lack of Efficacy | 2 | 1 | 1 |
| Overall Study | Lost to Follow-up | 11 | 15 | 20 |
| Overall Study | Protocol Violation | 3 | 2 | 6 |
| Overall Study | Reasons not defined | 2 | 3 | 4 |
| Overall Study | Withdrawal by Subject | 6 | 11 | 9 |
Baseline characteristics
| Characteristic | Placebo | DVS SR 50 mg | DVS SR 100 mg | Total |
|---|---|---|---|---|
| Age, Continuous | 41.72 Years STANDARD_DEVIATION 12.42 | 41.78 Years STANDARD_DEVIATION 13.56 | 41.30 Years STANDARD_DEVIATION 12.8 | 41.60 Years STANDARD_DEVIATION 12.92 |
| Sex: Female, Male Female | 173 Participants | 172 Participants | 165 Participants | 510 Participants |
| Sex: Female, Male Male | 127 Participants | 128 Participants | 144 Participants | 399 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 110 / 300 | 159 / 300 | 163 / 309 |
| serious Total, serious adverse events | 6 / 300 | 2 / 300 | 2 / 309 |
Outcome results
Primary
Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8
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). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. Change from baseline: score at observation minus score at baseline
Time frame: Baseline to Week 8 (final on-therapy)
Population: Intent-To-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least 1 post-baseline HAM-D17 total score. Imputation technique: Analysis of covariance (ANCOVA) was used based on last-observation-carried-forward (LOCF) data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8 | -9.50 Units on a scale | Standard Error 0.44 |
| DVS SR 50 mg | Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8 | -10.86 Units on a scale | Standard Error 0.43 |
| DVS SR 100 mg | Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8 | -11.16 Units on a scale | Standard Error 0.43 |
Comparison: To assess the sensitivity of the results to the missing data assumptions, an analysis of covariance (ANCOVA) model based on the last observation carried forward (LOCF) was used. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).p-value: 0.01495% CI: [0.28, 2.45]ANCOVA
Comparison: To assess the sensitivity of the results to the missing data assumptions, an analysis of covariance (ANCOVA) model based on the last observation carried forward (LOCF) was used. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).p-value: 0.00295% CI: [0.59, 2.74]ANCOVA
Primary
Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8
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). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. Change from baseline: score at observation minus score at baseline.
Time frame: Baseline to Week 8 (final on-therapy)
Population: Intent-To-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least 1 post-baseline HAM-D17 total score. Imputation technique: A mixed effects model for repeated measures (MMRM) was used with the baseline HAM-D17 score as a covariate.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8 | -9.71 Units on a scale | Standard Error 0.42 |
| DVS SR 50 mg | Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8 | -11.28 Units on a scale | Standard Error 0.42 |
| DVS SR 100 mg | Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8 | -11.67 Units on a scale | Standard Error 0.42 |
Comparison: A mixed effects model for repeated measures (MMRM) with treatment, visit, treatment by visit interaction, and site as fixed effects, and the baseline HAM-D17 score as a covariate was used to compare DVS SR dose to placebo. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).p-value: 0.00695% CI: [0.44, 2.69]Mixed Models Analysis
Comparison: A mixed effects model for repeated measures (MMRM) with treatment, visit, treatment by visit interaction, and site as fixed effects, and the baseline HAM-D17 score as a covariate was used to compare DVS SR dose to placebo. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).p-value: <0.00195% CI: [0.84, 3.08]Mixed Models Analysis
Secondary
Change From Baseline on the Arizona Sexual Experiences (ASEX) Scale Total Score
The ASEX scale has 5 items to assess sexual functioning with a 1-week recall period. The 5 items assess sex drive, ease of arousal, ease of erection/lubrication, ease of orgasm and orgasm satisfaction. Subjects were encouraged to complete all 5 items regardless of sexual activity during the past week. However, all analyses utilized only the data for the visits where the presence of sexual activity was indicated. Each individual score ranged from 1 to 6; the total score (based on the sum of the individual items) ranged from 5 to 30; higher scores indicated worse sexual function.
Time frame: Baseline to Week 8 (final on-therapy)
Population: Safety population: randomized subjects who have taken at least 1 dose of double-blind investigational product. Imputation technique: ASEX scale total score analyzed using analysis of covariance based on LOCF data. ASEX data only analyzed for subjects indicating sexual activity at baseline and a timepoint during post-baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline on the Arizona Sexual Experiences (ASEX) Scale Total Score | -0.45 Units on a scale | Standard Error 0.36 |
| DVS SR 50 mg | Change From Baseline on the Arizona Sexual Experiences (ASEX) Scale Total Score | -0.35 Units on a scale | Standard Error 0.35 |
| DVS SR 100 mg | Change From Baseline on the Arizona Sexual Experiences (ASEX) Scale Total Score | -0.13 Units on a scale | Standard Error 0.33 |
Comparison: The treatment by gender interaction was first tested using an analysis of covariance (ANCOVA) model with treatment, site, gender, and treatment by gender as factors and the baseline total score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).p-value: 0.83795% CI: [-0.98, 0.8]ANCOVA
Comparison: The treatment by gender interaction was first tested using an analysis of covariance (ANCOVA) model with treatment, site, gender, and treatment by gender as factors and the baseline total score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).p-value: 0.47195% CI: [-1.19, 0.55]ANCOVA
Secondary
Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I)
CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Higher score = worse outcome.
Time frame: Baseline to Week 8 (final on-therapy)
Population: Intent-To-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least 1 post-baseline HAM-D17 total score. Imputation technique: The Cochran-Mantel-Haenszel row-mean-score-difference test using ridit scores based on last-observation-carried-forward (LOCF) data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I) | 2=Much improved | 76 number of participants |
| Placebo | Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I) | 5=Minimally worse | 7 number of participants |
| Placebo | Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I) | 4=No change | 73 number of participants |
| Placebo | Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I) | 1=Very much improved | 55 number of participants |
| Placebo | Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I) | 7=Very much worse | 0 number of participants |
| Placebo | Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I) | 6=Much worse | 0 number of participants |
| Placebo | Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I) | 3=Minimally improved | 83 number of participants |
| DVS SR 50 mg | Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I) | 4=No change | 48 number of participants |
| DVS SR 50 mg | Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I) | 1=Very much improved | 57 number of participants |
| DVS SR 50 mg | Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I) | 2=Much improved | 104 number of participants |
| DVS SR 50 mg | Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I) | 3=Minimally improved | 79 number of participants |
| DVS SR 50 mg | Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I) | 5=Minimally worse | 3 number of participants |
| DVS SR 50 mg | Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I) | 6=Much worse | 0 number of participants |
| DVS SR 50 mg | Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I) | 7=Very much worse | 0 number of participants |
| DVS SR 100 mg | Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I) | 5=Minimally worse | 4 number of participants |
| DVS SR 100 mg | Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I) | 2=Much improved | 98 number of participants |
| DVS SR 100 mg | Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I) | 7=Very much worse | 0 number of participants |
| DVS SR 100 mg | Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I) | 6=Much worse | 0 number of participants |
| DVS SR 100 mg | Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I) | 4=No change | 49 number of participants |
| DVS SR 100 mg | Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I) | 3=Minimally improved | 69 number of participants |
| DVS SR 100 mg | Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I) | 1=Very much improved | 81 number of participants |
Comparison: CGI-I was analyzed with the Cochran-Mantel-Haenszel row-mean-score-difference test using ridit scores. Each DVS SR arm was separately compared to placebo controlling for site. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).p-value: 0.029Cochran-Mantel-Haenszel
Comparison: CGI-I was analyzed with the Cochran-Mantel-Haenszel row-mean-score-difference test using ridit scores. Each DVS SR arm was separately compared to placebo controlling for site. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).p-value: <0.001Cochran-Mantel-Haenszel
Secondary
Change From Baseline on the Clinical Global Impression-Severity (CGI-S) Score
CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = worse state.
Time frame: Baseline to Week 8 (final on-therapy)
Population: Intent-to-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least 1 post-baseline HAM-D17 total score. Imputation technique: Analysis of covariance (ANCOVA) was used based on last-observation-carried-forward (LOCF) data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline on the Clinical Global Impression-Severity (CGI-S) Score | -1.21 Units on scale | Standard Error 0.07 |
| DVS SR 50 mg | Change From Baseline on the Clinical Global Impression-Severity (CGI-S) Score | -1.38 Units on scale | Standard Error 0.07 |
| DVS SR 100 mg | Change From Baseline on the Clinical Global Impression-Severity (CGI-S) Score | -1.43 Units on scale | Standard Error 0.07 |
Comparison: To assess the sensitivity of the results to the missing data assumptions, an analysis of covariance (ANCOVA) model based on the last observation carried forward (LOCF) was used. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).p-value: 0.06295% CI: [-0.01, 0.34]ANCOVA
Comparison: To assess the sensitivity of the results to the missing data assumptions, an analysis of covariance (ANCOVA) model based on the last observation carried forward (LOCF) was used. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).p-value: 0.01495% CI: [0.04, 0.39]ANCOVA
Secondary
Change From Baseline on the Clinical Global Impression-Severity Score (CGI-S)
CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = worse state.
Time frame: Baseline to Week 8 (final on-therapy)
Population: Intent-To-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least 1 post-baseline HAM-D17 total score. Imputation technique: A mixed effects model for repeated measures (MMRM) was used with the baseline CGI-S score as a covariate.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline on the Clinical Global Impression-Severity Score (CGI-S) | -1.27 Units on scale | Standard Error 0.06 |
| DVS SR 50 mg | Change From Baseline on the Clinical Global Impression-Severity Score (CGI-S) | -1.47 Units on scale | Standard Error 0.06 |
| DVS SR 100 mg | Change From Baseline on the Clinical Global Impression-Severity Score (CGI-S) | -1.55 Units on scale | Standard Error 0.06 |
Comparison: CGI-S was analyzed using the mixed effects model for repeated measures (MMRM) with treatment, visit, treatment by visit interaction, and site as fixed effects, and the baseline CGI-S score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).p-value: 0.00995% CI: [0.05, 0.34]Mixed Models Analysis
Comparison: CGI-S was analyzed using the mixed effects model for repeated measures (MMRM) with treatment, visit, treatment by visit interaction, and site as fixed effects, and the baseline CGI-S score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).p-value: <0.00195% CI: [0.13, 0.43]Mixed Models Analysis
Secondary
Hamilton Rating Scale for Depression, 17-item (HAM-D17) Remission Rate
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). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) total score of ≤ 7.
Time frame: Baseline to week 8 (final on-therapy)
Population: Intent-to-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least one post-baseline HAM-D17 total score. Imputation technique: A logistic regression model based on last- observation-carried-forward (LOCF) data was used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Hamilton Rating Scale for Depression, 17-item (HAM-D17) Remission Rate | 21.77 percentage of the number of participants |
| DVS SR 50 mg | Hamilton Rating Scale for Depression, 17-item (HAM-D17) Remission Rate | 24.05 percentage of the number of participants |
| DVS SR 100 mg | Hamilton Rating Scale for Depression, 17-item (HAM-D17) Remission Rate | 28.57 percentage of the number of participants |
Comparison: Remission in HAM-D17 was analyzed based on a logistic regression model with treatment and site as fixed factors and the baseline HAM-D17 total score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).p-value: 0.61595% CI: [0.749, 1.631]Regression, Logistic
Comparison: Remission in HAM-D17 was analyzed based on a logistic regression model with treatment and site as fixed factors and the baseline HAM-D17 total score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).p-value: 0.07295% CI: [0.969, 2.057]Regression, Logistic
Secondary
Hamilton Rating Scale for Depression, 17-item (HAM-D17) Response Rate
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). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. A response is defined as ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression (HAM-D17) total score.
Time frame: Baseline to Week 8 (final on-therapy)
Population: Intent-to-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least one post-baseline HAM-D17 total score. Imputation technique: A logistic regression model based on last-observation-carried-forward (LOCF) data was used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Hamilton Rating Scale for Depression, 17-item (HAM-D17) Response Rate | 39.46 percentage of the number of participants |
| DVS SR 50 mg | Hamilton Rating Scale for Depression, 17-item (HAM-D17) Response Rate | 45.02 percentage of the number of participants |
| DVS SR 100 mg | Hamilton Rating Scale for Depression, 17-item (HAM-D17) Response Rate | 47.51 percentage of the number of participants |
Comparison: Response in HAM-D17 was analyzed based on a logistic regression model with treatment and site as fixed factors and the baseline HAM-D17 total score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).p-value: 0.19895% CI: [0.893, 1.726]Regression, Logistic
Comparison: Response in HAM-D17 was analyzed based on a logistic regression model with treatment and site as fixed factors and the baseline HAM-D17 total score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).p-value: 0.05495% CI: [0.995, 1.91]Regression, Logistic