Trial Outcomes & Findings for Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) In The Treatment Of Major Depressive Disorder (NCT NCT00384033)

Last Updated: 2012-03-15

Results Overview

HAM-D17: a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0 = none/absent and 4 = most severe, for a maximum total score of 50.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

638 participants

Primary outcome timeframe

Baseline and Week 8 or FOT

Results posted on

2012-03-15

Participant Flow

Study was conducted from 27 September 2006 to 28 September 2007 in United States (US) only.

A total of 925 participants were screened for this study and 638 participants were randomized. The remaining 287 participants were not randomized due to screen failures.

Participant milestones

Participant milestones
Measure	Placebo Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).	DVS SR 50 mg DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).	DVS SR 100 mg DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).	Duloxetine 60 mg Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
Overall Study STARTED	164	155	160	159
Overall Study Treated	161	148	150	157
Overall Study COMPLETED	123	120	117	119
Overall Study NOT COMPLETED	41	35	43	40

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).	DVS SR 50 mg DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).	DVS SR 100 mg DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).	Duloxetine 60 mg Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
Overall Study Adverse Event	10	8	11	20
Overall Study Failed to return	1	3	2	2
Overall Study Physician Decision	1	0	0	0
Overall Study Lost to Follow-up	6	12	7	7
Overall Study Other	2	0	0	0
Overall Study Protocol Violation	5	0	5	6
Overall Study Withdrawal by Subject	6	2	5	2
Overall Study Lack of Efficacy	7	3	3	1
Overall Study Randomized but not treated	3	7	10	2

Baseline Characteristics

Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) In The Treatment Of Major Depressive Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=161 Participants Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).	DVS SR 50 mg n=148 Participants DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).	DVS SR 100 mg n=150 Participants DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).	Duloxetine 60 mg n=157 Participants Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).	Total n=616 Participants Total of all reporting groups
Age Continuous	39.24 Years STANDARD_DEVIATION 12.74 • n=5 Participants	40.67 Years STANDARD_DEVIATION 13.20 • n=7 Participants	38.77 Years STANDARD_DEVIATION 12.07 • n=5 Participants	38.94 Years STANDARD_DEVIATION 12.01 • n=4 Participants	39.39 Years STANDARD_DEVIATION 12.50 • n=21 Participants
Sex: Female, Male Female	94 Participants n=5 Participants	102 Participants n=7 Participants	99 Participants n=5 Participants	104 Participants n=4 Participants	399 Participants n=21 Participants
Sex: Female, Male Male	67 Participants n=5 Participants	46 Participants n=7 Participants	51 Participants n=5 Participants	53 Participants n=4 Participants	217 Participants n=21 Participants
Hamilton psychiatric scale for depression-17 item (HAM-D17) total score	23.86 Units on a Scale STANDARD_DEVIATION 2.68 • n=5 Participants	23.49 Units on a Scale STANDARD_DEVIATION 2.52 • n=7 Participants	23.49 Units on a Scale STANDARD_DEVIATION 2.55 • n=5 Participants	22.99 Units on a Scale STANDARD_DEVIATION 2.45 • n=4 Participants	23.46 Units on a Scale STANDARD_DEVIATION 2.57 • n=21 Participants
Clinical global impressions scale-severity (CGI-S) score	4.39 Units on a Scale STANDARD_DEVIATION 0.54 • n=5 Participants	4.29 Units on a Scale STANDARD_DEVIATION 0.48 • n=7 Participants	4.31 Units on a Scale STANDARD_DEVIATION 0.49 • n=5 Participants	4.28 Units on a Scale STANDARD_DEVIATION 0.46 • n=4 Participants	4.32 Units on a Scale STANDARD_DEVIATION 0.50 • n=21 Participants

PRIMARY outcome

Timeframe: Baseline and Week 8 or FOT

Population: Intent-to-treat (ITT) population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.

Outcome measures

Outcome measures
Measure	Placebo n=160 Participants Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).	DVS SR 50 mg n=148 Participants DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).	DVS SR 100 mg n=150 Participants DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).	Duloxetine 60 mg n=157 Participants Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
Change From Baseline in HAM-D17 Total Score at Week 8 or Final On-therapy (FOT) Evaluation	-8.68 Units on a Scale Standard Error 0.58	-9.75 Units on a Scale Standard Error 0.60	-10.5 Units on a Scale Standard Error 0.60	-10.3 Units on a Scale Standard Error 0.60

SECONDARY outcome

Timeframe: Week 8 or FOT

Population: ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.

CGI-I: 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 relative to the baseline assessment. Higher score = more affected.

Outcome measures

Outcome measures
Measure	Placebo n=160 Participants Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).	DVS SR 50 mg n=148 Participants DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).	DVS SR 100 mg n=150 Participants DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).	Duloxetine 60 mg n=157 Participants Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
Number of Participants With Categorical Scores on CGI-Improvement (CGI-I) Score at Week 8 or FOT Evaluation 1 = Very much improved	31 Participants	27 Participants	45 Participants	45 Participants
Number of Participants With Categorical Scores on CGI-Improvement (CGI-I) Score at Week 8 or FOT Evaluation 2 = Much improved	32 Participants	38 Participants	37 Participants	35 Participants
Number of Participants With Categorical Scores on CGI-Improvement (CGI-I) Score at Week 8 or FOT Evaluation 3 = Minimally improved	35 Participants	47 Participants	28 Participants	37 Participants
Number of Participants With Categorical Scores on CGI-Improvement (CGI-I) Score at Week 8 or FOT Evaluation 4 = No change	57 Participants	34 Participants	37 Participants	37 Participants
Number of Participants With Categorical Scores on CGI-Improvement (CGI-I) Score at Week 8 or FOT Evaluation 5 = Minimally worse	5 Participants	2 Participants	2 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline and Week 8 or FOT

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 participants). Higher score = more affected.

Outcome measures

Outcome measures
Measure	Placebo n=160 Participants Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).	DVS SR 50 mg n=148 Participants DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).	DVS SR 100 mg n=150 Participants DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).	Duloxetine 60 mg n=157 Participants Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
Change From Baseline in Mean CGI-S Score at Week 8 or FOT Evaluation	-1.10 Units on a Scale Standard Error 0.09	-1.25 Units on a Scale Standard Error 0.10	-1.44 Units on a Scale Standard Error 0.10	-1.41 Units on a Scale Standard Error 0.10

SECONDARY outcome

Timeframe: Baseline and Week 8 or FOT

MADRS measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).

Outcome measures

Outcome measures
Measure	Placebo n=160 Participants Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).	DVS SR 50 mg n=148 Participants DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).	DVS SR 100 mg n=150 Participants DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).	Duloxetine 60 mg n=157 Participants Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score at Week 8 or FOT Evaluation Baseline	31.10 Units on a Scale Standard Error NA Standard error (SE) for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.	30.10 Units on a Scale Standard Error NA SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.	30.70 Units on a Scale Standard Error NA SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.	30.80 Units on a Scale Standard Error NA SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.
Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score at Week 8 or FOT Evaluation Change at Week 8 or FOT	-11.00 Units on a Scale Standard Error 0.82	-12.70 Units on a Scale Standard Error 0.85	-14.40 Units on a Scale Standard Error 0.84	-14.40 Units on a Scale Standard Error 0.87

SECONDARY outcome

Timeframe: Baseline and Week 8 or FOT

Lassitude item of MADRS represents a difficulty in getting started or slowness in initiating and performing everyday activities. It is rated on a scale of 0-6: 0 = hardly any difficulty in getting started/no sluggishness; 2 = difficulties in starting activities; 4 = difficulties in starting simple routine activities which are carried out with effort; 6 = complete lassitude/unable to do anything without help.

Outcome measures

Outcome measures
Measure	Placebo n=160 Participants Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).	DVS SR 50 mg n=148 Participants DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).	DVS SR 100 mg n=150 Participants DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).	Duloxetine 60 mg n=157 Participants Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
Change From Baseline in the Lassitude Item of the MADRS Scale at Week 8 or FOT Evaluation Baseline	3.49 Units on a Scale Standard Error NA SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.	3.53 Units on a Scale Standard Error NA SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.	3.70 Units on a Scale Standard Error NA SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.	3.50 Units on a Scale Standard Error NA SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.
Change From Baseline in the Lassitude Item of the MADRS Scale at Week 8 or FOT Evaluation Change at Week 8 or FOT	-1.27 Units on a Scale Standard Error 0.12	-1.39 Units on a Scale Standard Error 0.13	-1.54 Units on a Scale Standard Error 0.13	-1.26 Units on a Scale Standard Error 0.12

SECONDARY outcome

Timeframe: Baseline and Week 8 or FOT

HAM-D6: a standardized, clinician-administered rating scale that assesses 6 items characteristically associated with major depression and is a subset of HAM-D17. HAM-D6 score ranges from 0-22. The scale uses HAM-D17 items: 1, 2, 7, 8, 10 and 13. Item 13 is scored 0-2 (0=none and 2=severe) and all others are scored 0-4 (0=none/absent and 4=most severe).

Outcome measures

Outcome measures
Measure	Placebo n=160 Participants Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).	DVS SR 50 mg n=148 Participants DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).	DVS SR 100 mg n=150 Participants DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).	Duloxetine 60 mg n=157 Participants Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
Change From Baseline in HAM-D6 Total Score at Week 8 or FOT Evaluation Baseline	13.00 Units on a Scale Standard Error NA SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.	12.80 Units on a Scale Standard Error NA SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.	12.90 Units on a Scale Standard Error NA SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.	12.90 Units on a Scale Standard Error NA SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.
Change From Baseline in HAM-D6 Total Score at Week 8 or FOT Evaluation Change at Week 8 or FOT	-4.82 Units on a Scale Standard Error 0.33	-5.41 Units on a Scale Standard Error 0.35	-6.15 Units on a Scale Standard Error 0.34	-5.91 Units on a Scale Standard Error 0.36

SECONDARY outcome

Timeframe: Baseline and Week 8 or FOT

HAM-D energy subscale is a subset of the HAM-D17 that assesses 4 items associated with major depression. The scale uses HAM- D17 items 1, 7, 8 and 14. Item 14 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).

Outcome measures

Outcome measures
Measure	Placebo n=160 Participants Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).	DVS SR 50 mg n=148 Participants DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).	DVS SR 100 mg n=150 Participants DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).	Duloxetine 60 mg n=157 Participants Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
Change From Baseline in the HAM-D Energy Subscale Score at Week 8 or FOT Evaluation Baseline	8.38 Units on a Scale Standard Error NA SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.	8.43 Units on a Scale Standard Error NA SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.	8.51 Units on a Scale Standard Error NA SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.	8.38 Units on a Scale Standard Error NA SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.
Change From Baseline in the HAM-D Energy Subscale Score at Week 8 or FOT Evaluation Change at Week 8 or FOT	-3.13 Units on a Scale Standard Error 0.23	-3.66 Units on a Scale Standard Error 0.23	-3.92 Units on a Scale Standard Error 0.23	-3.80 Units on a Scale Standard Error 0.24

SECONDARY outcome

Timeframe: Baseline and Week 8 or FOT

COVI anxiety scale measures the severity of anxiety symptoms on 3 items: verbal report, behavior and somatic complaints. Each dimension is assessed using a 5-point scale: 1 = not at all, 2 = somewhat, 3 = moderately, 4 = considerably, to 5 = Very much. Worst value is 15 and best value is 3.

Outcome measures

Outcome measures
Measure	Placebo n=160 Participants Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).	DVS SR 50 mg n=148 Participants DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).	DVS SR 100 mg n=150 Participants DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).	Duloxetine 60 mg n=157 Participants Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
Change From Baseline in Covi Anxiety Scale at Week 8 or FOT Evaluation Baseline	6.50 Units on a Scale Standard Error NA SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.	6.30 Units on a Scale Standard Error NA SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.	6.30 Units on a Scale Standard Error NA SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.	6.30 Units on a Scale Standard Error NA SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.
Change From Baseline in Covi Anxiety Scale at Week 8 or FOT Evaluation Change at Week 8 or FOT	-1.02 Units on a Scale Standard Error 0.12	-1.15 Units on a Scale Standard Error 0.13	-1.35 Units on a Scale Standard Error 0.13	-1.47 Units on a Scale Standard Error 0.13

SECONDARY outcome

Timeframe: Baseline and Week 8 or FOT

VAS-PI scale assesses intensity of back pain, chest pain, arms, legs or joint pain as well as overall pain intensity where 100 mm line (VAS) is marked by participant and intensity of pain ranges from 0 millimetre (mm) = no pain to 100 mm = worst possible pain. There were separate 0 to 100 mm VAS lines for each subcomponent of VAS-PI.

Outcome measures

Outcome measures
Measure	Placebo n=160 Participants Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).	DVS SR 50 mg n=148 Participants DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).	DVS SR 100 mg n=150 Participants DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).	Duloxetine 60 mg n=157 Participants Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
Change From Baseline in Visual Analog Scale-Pain Intensity (VAS-PI) Overall and Subcomponent Score at Week 8 or FOT Evaluation Chest pain (Change at Week 8 or FOT)	-1.95 mm Standard Error 1.12	-3.34 mm Standard Error 1.17	-3.90 mm Standard Error 1.16	-1.67 mm Standard Error 1.21
Change From Baseline in Visual Analog Scale-Pain Intensity (VAS-PI) Overall and Subcomponent Score at Week 8 or FOT Evaluation Overall pain (Baseline)	26.30 mm Standard Error NA SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.	30.80 mm Standard Error NA SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.	25.90 mm Standard Error NA SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.	26.10 mm Standard Error NA SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.
Change From Baseline in Visual Analog Scale-Pain Intensity (VAS-PI) Overall and Subcomponent Score at Week 8 or FOT Evaluation Stomach pain (Baseline)	16.70 mm Standard Error NA SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.	19.40 mm Standard Error NA SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.	17.00 mm Standard Error NA SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.	14.00 mm Standard Error NA SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.
Change From Baseline in Visual Analog Scale-Pain Intensity (VAS-PI) Overall and Subcomponent Score at Week 8 or FOT Evaluation Back pain (Baseline)	25.90 mm Standard Error NA SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.	32.90 mm Standard Error NA SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.	28.30 mm Standard Error NA SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.	25.50 mm Standard Error NA SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.
Change From Baseline in Visual Analog Scale-Pain Intensity (VAS-PI) Overall and Subcomponent Score at Week 8 or FOT Evaluation Chest pain (Baseline)	9.40 mm Standard Error NA SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.	10.90 mm Standard Error NA SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.	10.40 mm Standard Error NA SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.	6.60 mm Standard Error NA SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.
Change From Baseline in Visual Analog Scale-Pain Intensity (VAS-PI) Overall and Subcomponent Score at Week 8 or FOT Evaluation Arms, legs or joint pain (Baseline)	25.80 mm Standard Error NA SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.	29.10 mm Standard Error NA SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.	28.70 mm Standard Error NA SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.	22.40 mm Standard Error NA SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.
Change From Baseline in Visual Analog Scale-Pain Intensity (VAS-PI) Overall and Subcomponent Score at Week 8 or FOT Evaluation Overall pain (Change at Week 8 or FOT)	-5.61 mm Standard Error 1.57	-9.08 mm Standard Error 1.64	-10.30 mm Standard Error 1.63	-8.84 mm Standard Error 1.74
Change From Baseline in Visual Analog Scale-Pain Intensity (VAS-PI) Overall and Subcomponent Score at Week 8 or FOT Evaluation Stomach pain (Change at Week 8 or FOT)	-1.86 mm Standard Error 1.62	-4.98 mm Standard Error 1.69	-6.42 mm Standard Error 1.68	-4.38 mm Standard Error 1.58
Change From Baseline in Visual Analog Scale-Pain Intensity (VAS-PI) Overall and Subcomponent Score at Week 8 or FOT Evaluation Back pain (Change at Week 8 or FOT)	-7.04 mm Standard Error 1.67	-10.70 mm Standard Error 1.74	-12.80 mm Standard Error 1.73	-9.33 mm Standard Error 1.83
Change From Baseline in Visual Analog Scale-Pain Intensity (VAS-PI) Overall and Subcomponent Score at Week 8 or FOT Evaluation Arms, legs or joint pain (Change at Week 8 or FOT)	-6.99 mm Standard Error 1.70	-8.98 mm Standard Error 1.76	-11.90 mm Standard Error 1.76	-8.35 mm Standard Error 1.64

Adverse Events

Placebo

Serious events: 2 serious events

Other events: 129 other events

Deaths: 0 deaths

DVS SR 50 mg

Serious events: 2 serious events

Other events: 134 other events

Deaths: 0 deaths

DVS SR 100 mg

Serious events: 2 serious events

Other events: 134 other events

Deaths: 0 deaths

Duloxetine 60 mg

Serious events: 1 serious events

Other events: 141 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=161 participants at risk Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).	DVS SR 50 mg n=148 participants at risk DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).	DVS SR 100 mg n=150 participants at risk DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).	Duloxetine 60 mg n=157 participants at risk Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
General disorders Accidental injury	0.62% 1/161 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.68% 1/148 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/150 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/157 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Suicide attempt	0.00% 0/161 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/148 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/150 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.64% 1/157 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gastrointestinal hemorrhage	0.00% 0/161 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/148 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.67% 1/150 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/157 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Suicidal ideation	0.00% 0/161 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.68% 1/148 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/150 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/157 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Asthma	0.62% 1/161 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/148 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/150 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/157 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Menorrhagia	0.00% 0/161 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/148 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.67% 1/150 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/157 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Other adverse events

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER