Major Depressive Disorder
Conditions
Keywords
major depressive disorder, MDD, depression
Brief summary
This is a Double-blind Study Evaluating Desvenlafaxine Succinate (DVS SR) Sustained Release vs Placebo in the Treatment of Children and Adolescent Outpatients with Major Depressive Disorder (MDD).
Interventions
Subjects randomized to DVS SR group receive 25, 35 or 50 mg/day based on subject weight at the Baseline visit. DVS SR provided as oral tablets.
DRUGfluoxetine
Subjects randomized to the fluoxetine group receive 20 mg/day. Fluoxetine provided as oral capsules
DRUGplacebo
Subjects randomized to the placebo group receive corresponding placebo tablets and/capsules
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
7 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Age \>=7 and \<18 years of age * Primary diagnosis of major depressive disorder (MDD) * CDRS-R score \>40
Exclusion criteria
* History of suicidal behaviour, or requires precaution against suicide * Not in generally healthy medical condition * History of psychosis or bipolar disorder * Seizure disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score | Baseline and Week 8 | Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment. Adjusted mean presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score | Baseline and Week 8 | A 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 = more affected. Change: score at observation minus score at baseline. Adjusted mean presented. |
| Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Baseline and Weeks 1, 2, 3, 4, 6, and 8 | A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. |
| Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved' | Weeks 1, 2, 3, 4, 6, and 8 | A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. |
Countries
Mexico, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase). | 112 |
| Fluoxetine Fluoxetine capsules 10 mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily for 1 week as appropriate (taper/transition phase). | 112 |
| DVS SR DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week. | 115 |
| Total | 339 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 | 2 |
| Overall Study | Lack of Efficacy | 3 | 0 | 1 |
| Overall Study | Lost to Follow-up | 4 | 5 | 6 |
| Overall Study | Other | 1 | 0 | 2 |
| Overall Study | Protocol Violation | 1 | 0 | 3 |
| Overall Study | Randomized but not treated | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 7 | 2 |
Baseline characteristics
| Characteristic | Placebo | Fluoxetine | DVS SR | Total |
|---|---|---|---|---|
| Age, Continuous | 12.6 Years STANDARD_DEVIATION 2.89 | 12.6 Years STANDARD_DEVIATION 2.89 | 12.9 Years STANDARD_DEVIATION 3.12 | 12.7 Years STANDARD_DEVIATION 2.96 |
| Sex: Female, Male Female | 64 Participants | 57 Participants | 63 Participants | 184 Participants |
| Sex: Female, Male Male | 48 Participants | 55 Participants | 52 Participants | 155 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 | 44 / 112 | 39 / 112 | 47 / 115 |
| serious Total, serious adverse events | 0 / 112 | 2 / 112 | 2 / 115 |
Outcome results
Primary
Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score
Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment. Adjusted mean presented.
Time frame: Baseline and Week 8
Population: Intention-To-Treat (ITT) Population - included all randomized participants who received at least 1 dose of study drug, had a baseline primary efficacy assessment, and had at least one post-baseline primary efficacy assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score | -23.07 Score on a Scale | Standard Error 1.18 |
| Fluoxetine | Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score | -24.79 Score on a Scale | Standard Error 1.17 |
| DVS SR | Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score | -22.61 Score on a Scale | Standard Error 1.17 |
Comparison: Fluoxetine versus Placebop-value: 0.22695% CI: [-1.06, 4.48]Mixed-effects model for repeated measure
Comparison: DVS SR versus Placebop-value: 0.73995% CI: [-3.23, 2.3]MMRM
Secondary
Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score
A 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 = more affected. Change: score at observation minus score at baseline. Adjusted mean presented.
Time frame: Baseline and Week 8
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score | -1.71 Score on a Scale | Standard Error 0.12 |
| Fluoxetine | Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score | -1.88 Score on a Scale | Standard Error 0.12 |
| DVS SR | Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score | -1.70 Score on a Scale | Standard Error 0.11 |
Comparison: Fluoxetine versus Placebop-value: 0.22495% CI: [-0.11, 0.46]MMRM
Comparison: DVS SR versus Placebop-value: 0.94495% CI: [-0.29, 0.27]MMRM
Secondary
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8
A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
Time frame: Baseline and Weeks 1, 2, 3, 4, 6, and 8
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 2, Minimally Worse (n=103, 105, 110) | 1.9 Percentage of Participants |
| Placebo | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 8, Very Much Improved (n=99, 101, 99) | 27.3 Percentage of Participants |
| Placebo | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 2, Much Worse (n=103, 105, 110) | 0 Percentage of Participants |
| Placebo | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 6, Very Much Worse (n=100, 100, 102) | 0 Percentage of Participants |
| Placebo | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 4, Minimally Worse (n=101, 101, 100) | 2.0 Percentage of Participants |
| Placebo | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 2, Very Much Worse (n=103, 105, 110) | 0 Percentage of Participants |
| Placebo | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 1, Very Much Improved (n=102, 101, 111) | 1.0 Percentage of Participants |
| Placebo | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 4, No Change (n=101, 101, 100) | 13.9 Percentage of Participants |
| Placebo | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 8, Much Worse (n=99, 101, 99) | 0 Percentage of Participants |
| Placebo | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 4, Minimally Improved (n=101, 101, 100) | 29.7 Percentage of Participants |
| Placebo | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 3, Much Improved (n=105, 102, 107) | 29.5 Percentage of Participants |
| Placebo | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 6, Much Worse (n=100, 100, 102) | 1.0 Percentage of Participants |
| Placebo | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 4, Very Much Improved (n=101, 101, 100) | 15.8 Percentage of Participants |
| Placebo | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 3, Minimally Improved (n=105, 102, 107) | 41.0 Percentage of Participants |
| Placebo | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 1, Much Improved (n=102, 101, 111) | 7.8 Percentage of Participants |
| Placebo | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 3, No Change (n=105, 102, 107) | 15.2 Percentage of Participants |
| Placebo | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 8, Minimally Worse (n=99, 101, 99) | 1.0 Percentage of Participants |
| Placebo | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 3, Very Much Worse (n=105, 102, 107) | 0 Percentage of Participants |
| Placebo | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 3, Minimally Worse (n=105, 102, 107) | 1.0 Percentage of Participants |
| Placebo | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 1, Minimally Improved (n=102, 101, 111) | 46.1 Percentage of Participants |
| Placebo | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 3, Much Worse (n=105, 102, 107) | 0 Percentage of Participants |
| Placebo | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 2, No Change (n=103, 105, 110) | 30.1 Percentage of Participants |
| Placebo | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 6, Minimally Worse (n=100, 100, 102) | 0 Percentage of Participants |
| Placebo | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 1, No Change (n=102, 101, 111) | 43.1 Percentage of Participants |
| Placebo | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 8, No Change (n=99, 101, 99) | 4.0 Percentage of Participants |
| Placebo | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 1, Minimally Worse (n=102, 101, 111) | 2.0 Percentage of Participants |
| Placebo | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 3, Very Much Improved (n=105, 102, 107) | 13.3 Percentage of Participants |
| Placebo | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 6, No Change (n=100, 100, 102) | 6.0 Percentage of Participants |
| Placebo | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 1, Much Worse (n=102, 101, 111) | 0 Percentage of Participants |
| Placebo | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 8, Minimally Improved (n=99, 101, 99) | 32.3 Percentage of Participants |
| Placebo | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 6, Minimally Improved (n=100, 100, 102) | 34.0 Percentage of Participants |
| Placebo | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 1, Very Much Worse (n=102, 101, 111) | 0 Percentage of Participants |
| Placebo | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 6, Much Improved (n=100, 100, 102) | 41.0 Percentage of Participants |
| Placebo | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 2, Very Much Improved (n=103, 105, 110) | 3.9 Percentage of Participants |
| Placebo | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 4, Much Improved (n=101, 101, 100) | 38.6 Percentage of Participants |
| Placebo | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 4, Very Much Worse (n=101, 101, 100) | 0 Percentage of Participants |
| Placebo | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 2, Much Improved (n=103, 105, 110) | 25.2 Percentage of Participants |
| Placebo | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 8, Very Much Worse (n=99, 101, 99) | 0 Percentage of Participants |
| Placebo | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 2, Minimally Improved (n=103, 105, 110) | 38.8 Percentage of Participants |
| Placebo | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 8, Much Improved (n=99, 101, 99) | 35.4 Percentage of Participants |
| Placebo | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 6, Very Much Improved (n=100, 100, 102) | 18.0 Percentage of Participants |
| Placebo | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 4, Much Worse (n=101, 101, 100) | 0 Percentage of Participants |
| Fluoxetine | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 8, Much Improved (n=99, 101, 99) | 47.5 Percentage of Participants |
| Fluoxetine | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 1, Very Much Worse (n=102, 101, 111) | 0 Percentage of Participants |
| Fluoxetine | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 4, Much Improved (n=101, 101, 100) | 47.5 Percentage of Participants |
| Fluoxetine | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 1, Very Much Improved (n=102, 101, 111) | 3.0 Percentage of Participants |
| Fluoxetine | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 1, Much Improved (n=102, 101, 111) | 11.9 Percentage of Participants |
| Fluoxetine | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 1, Minimally Improved (n=102, 101, 111) | 35.6 Percentage of Participants |
| Fluoxetine | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 1, No Change (n=102, 101, 111) | 47.5 Percentage of Participants |
| Fluoxetine | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 1, Minimally Worse (n=102, 101, 111) | 2.0 Percentage of Participants |
| Fluoxetine | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 1, Much Worse (n=102, 101, 111) | 0 Percentage of Participants |
| Fluoxetine | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 2, Very Much Improved (n=103, 105, 110) | 6.7 Percentage of Participants |
| Fluoxetine | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 2, Much Improved (n=103, 105, 110) | 26.7 Percentage of Participants |
| Fluoxetine | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 2, Minimally Improved (n=103, 105, 110) | 42.9 Percentage of Participants |
| Fluoxetine | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 2, No Change (n=103, 105, 110) | 22.9 Percentage of Participants |
| Fluoxetine | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 2, Minimally Worse (n=103, 105, 110) | 1.0 Percentage of Participants |
| Fluoxetine | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 2, Much Worse (n=103, 105, 110) | 0 Percentage of Participants |
| Fluoxetine | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 2, Very Much Worse (n=103, 105, 110) | 0 Percentage of Participants |
| Fluoxetine | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 3, Very Much Improved (n=105, 102, 107) | 14.7 Percentage of Participants |
| Fluoxetine | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 3, Much Improved (n=105, 102, 107) | 36.3 Percentage of Participants |
| Fluoxetine | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 3, Minimally Improved (n=105, 102, 107) | 36.3 Percentage of Participants |
| Fluoxetine | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 3, No Change (n=105, 102, 107) | 11.8 Percentage of Participants |
| Fluoxetine | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 3, Minimally Worse (n=105, 102, 107) | 1.0 Percentage of Participants |
| Fluoxetine | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 3, Much Worse (n=105, 102, 107) | 0 Percentage of Participants |
| Fluoxetine | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 3, Very Much Worse (n=105, 102, 107) | 0 Percentage of Participants |
| Fluoxetine | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 4, Very Much Improved (n=101, 101, 100) | 13.9 Percentage of Participants |
| Fluoxetine | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 4, Minimally Improved (n=101, 101, 100) | 27.7 Percentage of Participants |
| Fluoxetine | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 4, No Change (n=101, 101, 100) | 9.9 Percentage of Participants |
| Fluoxetine | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 4, Minimally Worse (n=101, 101, 100) | 1.0 Percentage of Participants |
| Fluoxetine | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 4, Much Worse (n=101, 101, 100) | 0 Percentage of Participants |
| Fluoxetine | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 4, Very Much Worse (n=101, 101, 100) | 0 Percentage of Participants |
| Fluoxetine | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 6, Very Much Improved (n=100, 100, 102) | 26.0 Percentage of Participants |
| Fluoxetine | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 6, Much Improved (n=100, 100, 102) | 45.0 Percentage of Participants |
| Fluoxetine | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 6, Minimally Improved (n=100, 100, 102) | 24.0 Percentage of Participants |
| Fluoxetine | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 6, No Change (n=100, 100, 102) | 5.0 Percentage of Participants |
| Fluoxetine | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 6, Minimally Worse (n=100, 100, 102) | 0 Percentage of Participants |
| Fluoxetine | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 6, Much Worse (n=100, 100, 102) | 0 Percentage of Participants |
| Fluoxetine | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 6, Very Much Worse (n=100, 100, 102) | 0 Percentage of Participants |
| Fluoxetine | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 8, Very Much Improved (n=99, 101, 99) | 30.7 Percentage of Participants |
| Fluoxetine | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 8, Minimally Improved (n=99, 101, 99) | 16.8 Percentage of Participants |
| Fluoxetine | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 8, No Change (n=99, 101, 99) | 4.0 Percentage of Participants |
| Fluoxetine | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 8, Minimally Worse (n=99, 101, 99) | 1.0 Percentage of Participants |
| Fluoxetine | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 8, Much Worse (n=99, 101, 99) | 0 Percentage of Participants |
| Fluoxetine | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 8, Very Much Worse (n=99, 101, 99) | 0 Percentage of Participants |
| DVS SR | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 2, Very Much Improved (n=103, 105, 110) | 3.6 Percentage of Participants |
| DVS SR | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 3, Minimally Improved (n=105, 102, 107) | 38.3 Percentage of Participants |
| DVS SR | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 4, Very Much Worse (n=101, 101, 100) | 0 Percentage of Participants |
| DVS SR | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 8, Very Much Worse (n=99, 101, 99) | 0 Percentage of Participants |
| DVS SR | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 6, Very Much Improved (n=100, 100, 102) | 23.5 Percentage of Participants |
| DVS SR | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 1, Very Much Worse (n=102, 101, 111) | 0 Percentage of Participants |
| DVS SR | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 2, Minimally Worse (n=103, 105, 110) | 0.9 Percentage of Participants |
| DVS SR | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 6, Much Improved (n=100, 100, 102) | 45.1 Percentage of Participants |
| DVS SR | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 1, Much Worse (n=102, 101, 111) | 0 Percentage of Participants |
| DVS SR | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 8, Much Worse (n=99, 101, 99) | 0 Percentage of Participants |
| DVS SR | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 6, Minimally Improved (n=100, 100, 102) | 20.6 Percentage of Participants |
| DVS SR | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 1, Minimally Worse (n=102, 101, 111) | 1.8 Percentage of Participants |
| DVS SR | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 8, No Change (n=99, 101, 99) | 9.1 Percentage of Participants |
| DVS SR | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 6, No Change (n=100, 100, 102) | 9.8 Percentage of Participants |
| DVS SR | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 1, Minimally Improved (n=102, 101, 111) | 43.2 Percentage of Participants |
| DVS SR | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 2, Minimally Improved (n=103, 105, 110) | 44.5 Percentage of Participants |
| DVS SR | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 6, Minimally Worse (n=100, 100, 102) | 1.0 Percentage of Participants |
| DVS SR | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 1, Very Much Improved (n=102, 101, 111) | 2.7 Percentage of Participants |
| DVS SR | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 1, No Change (n=102, 101, 111) | 45.9 Percentage of Participants |
| DVS SR | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 8, Minimally Improved (n=99, 101, 99) | 21.2 Percentage of Participants |
| DVS SR | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 8, Minimally Worse (n=99, 101, 99) | 1.0 Percentage of Participants |
| DVS SR | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 3, Minimally Worse (n=105, 102, 107) | 0.9 Percentage of Participants |
| DVS SR | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 6, Very Much Worse (n=100, 100, 102) | 0 Percentage of Participants |
| DVS SR | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 3, Much Worse (n=105, 102, 107) | 0 Percentage of Participants |
| DVS SR | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 3, No Change (n=105, 102, 107) | 11.2 Percentage of Participants |
| DVS SR | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 6, Much Worse (n=100, 100, 102) | 0 Percentage of Participants |
| DVS SR | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 3, Very Much Worse (n=105, 102, 107) | 0 Percentage of Participants |
| DVS SR | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 3, Much Improved (n=105, 102, 107) | 42.1 Percentage of Participants |
| DVS SR | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 2, Much Improved (n=103, 105, 110) | 31.8 Percentage of Participants |
| DVS SR | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 4, Very Much Improved (n=101, 101, 100) | 20.0 Percentage of Participants |
| DVS SR | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 4, Much Improved (n=101, 101, 100) | 44.0 Percentage of Participants |
| DVS SR | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 3, Very Much Improved (n=105, 102, 107) | 7.5 Percentage of Participants |
| DVS SR | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 8, Very Much Improved (n=99, 101, 99) | 23.2 Percentage of Participants |
| DVS SR | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 4, Minimally Improved (n=101, 101, 100) | 25.0 Percentage of Participants |
| DVS SR | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 2, Very Much Worse (n=103, 105, 110) | 0 Percentage of Participants |
| DVS SR | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 4, Minimally Worse (n=101, 101, 100) | 1.0 Percentage of Participants |
| DVS SR | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 4, No Change (n=101, 101, 100) | 10.0 Percentage of Participants |
| DVS SR | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 2, Much Worse (n=103, 105, 110) | 0 Percentage of Participants |
| DVS SR | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 1, Much Improved (n=102, 101, 111) | 6.3 Percentage of Participants |
| DVS SR | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 2, No Change (n=103, 105, 110) | 19.1 Percentage of Participants |
| DVS SR | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 8, Much Improved (n=99, 101, 99) | 45.5 Percentage of Participants |
| DVS SR | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | Week 4, Much Worse (n=101, 101, 100) | 0 Percentage of Participants |
Comparison: DVS SR versus Placebo - Week 8p-value: 0.852Cochran-Mantel-Haenszel
Comparison: Fluoxetine versus Placebo - Week 1p-value: 0.924Cochran-Mantel-Haenszel
Comparison: DVS SR versus Placebo - Week 1p-value: 0.698Cochran-Mantel-Haenszel
Comparison: Fluoxetine versus Placebo - Week 2p-value: 0.214Cochran-Mantel-Haenszel
Comparison: DVS SR versus Placebo - Week 2p-value: 0.113Cochran-Mantel-Haenszel
Comparison: Fluoxetine versus Placebo - Week 3p-value: 0.314Cochran-Mantel-Haenszel
Comparison: DVS SR versus Placebo - Week 3p-value: 0.659Cochran-Mantel-Haenszel
Comparison: Fluoxetine versus Placebo - Week 4p-value: 0.577Cochran-Mantel-Haenszel
Comparison: DVS SR versus Placebo - Week 4p-value: 0.187Cochran-Mantel-Haenszel
Comparison: Fluoxetine versus Placebo - Week 6p-value: 0.051Cochran-Mantel-Haenszel
Comparison: DVS SR versus Placebo - Week 6p-value: 0.266Cochran-Mantel-Haenszel
Comparison: Fluoxetine versus Placebo - Week 8p-value: 0.095Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved'
A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
Time frame: Weeks 1, 2, 3, 4, 6, and 8
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved' | Week 1 (n=102, 101, 111) | 8.82 Percentage of Participants |
| Placebo | Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved' | Week 3 (n=105, 102, 107) | 42.86 Percentage of Participants |
| Placebo | Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved' | Week 2 (n=103, 105, 110) | 29.13 Percentage of Participants |
| Placebo | Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved' | Week 4 (n=101, 101, 100) | 54.46 Percentage of Participants |
| Placebo | Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved' | Week 6 (n=100, 100, 102) | 59.00 Percentage of Participants |
| Placebo | Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved' | Week 8 (n=99, 101, 99) | 62.63 Percentage of Participants |
| Fluoxetine | Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved' | Week 2 (n=103, 105, 110) | 33.33 Percentage of Participants |
| Fluoxetine | Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved' | Week 3 (n=105, 102, 107) | 50.98 Percentage of Participants |
| Fluoxetine | Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved' | Week 4 (n=101, 101, 100) | 61.39 Percentage of Participants |
| Fluoxetine | Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved' | Week 8 (n=99, 101, 99) | 78.22 Percentage of Participants |
| Fluoxetine | Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved' | Week 6 (n=100, 100, 102) | 71.00 Percentage of Participants |
| Fluoxetine | Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved' | Week 1 (n=102, 101, 111) | 14.85 Percentage of Participants |
| DVS SR | Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved' | Week 1 (n=102, 101, 111) | 9.01 Percentage of Participants |
| DVS SR | Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved' | Week 6 (n=100, 100, 102) | 68.63 Percentage of Participants |
| DVS SR | Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved' | Week 3 (n=105, 102, 107) | 49.53 Percentage of Participants |
| DVS SR | Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved' | Week 8 (n=99, 101, 99) | 68.69 Percentage of Participants |
| DVS SR | Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved' | Week 2 (n=103, 105, 110) | 35.45 Percentage of Participants |
| DVS SR | Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved' | Week 4 (n=101, 101, 100) | 64.00 Percentage of Participants |
Comparison: Fluoxetine versus Placebo - Week 1p-value: 0.18695% CI: [0.226, 1.335]Regression, Logistic
Comparison: DVS SR versus Placebo - Week 1p-value: 0.98495% CI: [0.382, 2.567]Regression, Logistic
Comparison: Fluoxetine versus Placebo - Week 2p-value: 0.46295% CI: [0.431, 1.465]Regression, Logistic
Comparison: DVS SR versus Placebo - Week 2p-value: 0.29795% CI: [0.399, 1.324]Regression, Logistic
Comparison: Fluoxetine versus Placebo - Week 3p-value: 0.19495% CI: [0.391, 1.21]Regression, Logistic
Comparison: DVS SR versus Placebo - Week 3p-value: 0.27295% CI: [0.419, 1.277]Regression, Logistic
Comparison: Flouxetine versus Placebo - Week 4p-value: 0.31395% CI: [0.426, 1.314]Regression, Logistic
Comparison: DVS SR versus Placebo - Week 4p-value: 0.15795% CI: [0.376, 1.171]Regression, Logistic
Comparison: Flouxetine versus Placebo - Week 6p-value: 0.07295% CI: [0.319, 1.05]Regression, Logistic
Comparison: DVS SR versus Placebo - Week 6p-value: 0.13595% CI: [0.356, 1.149]Regression, Logistic
Comparison: Flouxetine versus Placebo - Week 8p-value: 0.01795% CI: [0.249, 0.871]Regression, Logistic
Comparison: DVS SR versus Placebo - Week 8p-value: 0.34395% CI: [0.415, 1.357]Regression, Logistic