Trial Outcomes & Findings for Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) in Adult Outpatients With Major Depressive Disorder (MDD) (NCT NCT01432457)
NCT ID: NCT01432457
Last Updated: 2014-01-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
924 participants
Primary outcome timeframe
Baseline to Week 8 (final on-therapy)
Results posted on
2014-01-20
Participant Flow
Subjects were recruited in the United States from October 2011 to May 2012.
Subjects were screened up to 2 weeks.
Participant milestones
| Measure |
Placebo
Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
306
|
306
|
312
|
|
Overall Study
COMPLETED
|
269
|
258
|
253
|
|
Overall Study
NOT COMPLETED
|
37
|
48
|
59
|
Reasons for withdrawal
| Measure |
Placebo
Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
7
|
10
|
16
|
|
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
Withdrawal by Subject
|
6
|
11
|
9
|
|
Overall Study
Reasons not defined
|
2
|
3
|
4
|
|
Overall Study
Did not take study drug
|
6
|
6
|
3
|
Baseline Characteristics
Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) in Adult Outpatients With Major Depressive Disorder (MDD)
Baseline characteristics by cohort
| Measure |
Placebo
n=300 Participants
Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
|
DVS SR 50 mg
n=300 Participants
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.
|
DVS SR 100 mg
n=309 Participants
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.
|
Total
n=909 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
41.72 Years
STANDARD_DEVIATION 12.42 • n=5 Participants
|
41.78 Years
STANDARD_DEVIATION 13.56 • n=7 Participants
|
41.30 Years
STANDARD_DEVIATION 12.80 • n=5 Participants
|
41.60 Years
STANDARD_DEVIATION 12.92 • n=4 Participants
|
|
Sex: Female, Male
Female
|
173 Participants
n=5 Participants
|
172 Participants
n=7 Participants
|
165 Participants
n=5 Participants
|
510 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
127 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
399 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=267 Participants
Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
|
DVS SR 50 mg
n=257 Participants
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.
|
DVS SR 100 mg
n=252 Participants
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.
|
|---|---|---|---|
|
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
|
-11.28 Units on a scale
Standard Error 0.42
|
-11.67 Units on a scale
Standard Error 0.42
|
PRIMARY outcome
Timeframe: 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.
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
Outcome measures
| Measure |
Placebo
n=294 Participants
Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
|
DVS SR 50 mg
n=291 Participants
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.
|
DVS SR 100 mg
n=301 Participants
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.
|
|---|---|---|---|
|
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
|
-10.86 Units on a scale
Standard Error 0.43
|
-11.16 Units on a scale
Standard Error 0.43
|
SECONDARY outcome
Timeframe: 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.
CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Higher score = worse outcome.
Outcome measures
| Measure |
Placebo
n=294 Participants
Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
|
DVS SR 50 mg
n=291 Participants
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.
|
DVS SR 100 mg
n=301 Participants
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.
|
|---|---|---|---|
|
Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I)
1=Very much improved
|
55 number of participants
|
57 number of participants
|
81 number of participants
|
|
Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I)
2=Much improved
|
76 number of participants
|
104 number of participants
|
98 number of participants
|
|
Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I)
3=Minimally improved
|
83 number of participants
|
79 number of participants
|
69 number of participants
|
|
Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I)
4=No change
|
73 number of participants
|
48 number of participants
|
49 number of participants
|
|
Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I)
5=Minimally worse
|
7 number of participants
|
3 number of participants
|
4 number of participants
|
|
Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I)
6=Much worse
|
0 number of participants
|
0 number of participants
|
0 number of participants
|
|
Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I)
7=Very much worse
|
0 number of participants
|
0 number of participants
|
0 number of participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=265 Participants
Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
|
DVS SR 50 mg
n=257 Participants
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.
|
DVS SR 100 mg
n=252 Participants
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.
|
|---|---|---|---|
|
Change From Baseline on the Clinical Global Impression-Severity Score (CGI-S)
|
-1.27 Units on scale
Standard Error 0.06
|
-1.47 Units on scale
Standard Error 0.06
|
-1.55 Units on scale
Standard Error 0.06
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=294 Participants
Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
|
DVS SR 50 mg
n=291 Participants
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.
|
DVS SR 100 mg
n=301 Participants
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.
|
|---|---|---|---|
|
Change From Baseline on the Clinical Global Impression-Severity (CGI-S) Score
|
-1.21 Units on scale
Standard Error 0.07
|
-1.38 Units on scale
Standard Error 0.07
|
-1.43 Units on scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=294 Participants
Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
|
DVS SR 50 mg
n=291 Participants
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.
|
DVS SR 100 mg
n=301 Participants
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.
|
|---|---|---|---|
|
Hamilton Rating Scale for Depression, 17-item (HAM-D17) Response Rate
|
39.46 percentage of the number of participants
|
45.02 percentage of the number of participants
|
47.51 percentage of the number of participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=294 Participants
Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
|
DVS SR 50 mg
n=291 Participants
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.
|
DVS SR 100 mg
n=301 Participants
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.
|
|---|---|---|---|
|
Hamilton Rating Scale for Depression, 17-item (HAM-D17) Remission Rate
|
21.77 percentage of the number of participants
|
24.05 percentage of the number of participants
|
28.57 percentage of the number of participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=135 Participants
Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
|
DVS SR 50 mg
n=138 Participants
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.
|
DVS SR 100 mg
n=149 Participants
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.
|
|---|---|---|---|
|
Change From Baseline on the Arizona Sexual Experiences (ASEX) Scale Total Score
|
-0.45 Units on a scale
Standard Error 0.36
|
-0.35 Units on a scale
Standard Error 0.35
|
-0.13 Units on a scale
Standard Error 0.33
|
Adverse Events
Placebo
Serious events: 6 serious events
Other events: 110 other events
Deaths: 0 deaths
DVS SR 50 mg
Serious events: 2 serious events
Other events: 159 other events
Deaths: 0 deaths
DVS SR 100 mg
Serious events: 2 serious events
Other events: 163 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=300 participants at risk
Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
|
DVS SR 50 mg
n=300 participants at risk
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.
|
DVS SR 100 mg
n=309 participants at risk
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.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.33%
1/300
The same event may appear as both an adverse event (AE) and a serious adverse event (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%
0/300
The same event may appear as both an adverse event (AE) and a serious adverse event (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%
0/309
The same event may appear as both an adverse event (AE) and a serious adverse event (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.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/300
The same event may appear as both an adverse event (AE) and a serious adverse event (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%
0/300
The same event may appear as both an adverse event (AE) and a serious adverse event (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.
|
0.32%
1/309
The same event may appear as both an adverse event (AE) and a serious adverse event (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
Constipation
|
0.33%
1/300
The same event may appear as both an adverse event (AE) and a serious adverse event (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%
0/300
The same event may appear as both an adverse event (AE) and a serious adverse event (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%
0/309
The same event may appear as both an adverse event (AE) and a serious adverse event (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
Hyperthermia
|
0.00%
0/300
The same event may appear as both an adverse event (AE) and a serious adverse event (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.
|
0.33%
1/300
The same event may appear as both an adverse event (AE) and a serious adverse event (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%
0/309
The same event may appear as both an adverse event (AE) and a serious adverse event (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.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/300
The same event may appear as both an adverse event (AE) and a serious adverse event (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.
|
0.33%
1/300
The same event may appear as both an adverse event (AE) and a serious adverse event (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%
0/309
The same event may appear as both an adverse event (AE) and a serious adverse event (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.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.33%
1/300
The same event may appear as both an adverse event (AE) and a serious adverse event (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%
0/300
The same event may appear as both an adverse event (AE) and a serious adverse event (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%
0/309
The same event may appear as both an adverse event (AE) and a serious adverse event (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.
|
|
Investigations
Electrocardiogram abnormal
|
0.33%
1/300
The same event may appear as both an adverse event (AE) and a serious adverse event (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%
0/300
The same event may appear as both an adverse event (AE) and a serious adverse event (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%
0/309
The same event may appear as both an adverse event (AE) and a serious adverse event (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.
|
|
Investigations
Serum serotonin increased
|
0.00%
0/300
The same event may appear as both an adverse event (AE) and a serious adverse event (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.
|
0.33%
1/300
The same event may appear as both an adverse event (AE) and a serious adverse event (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%
0/309
The same event may appear as both an adverse event (AE) and a serious adverse event (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
Motor dysfunction
|
0.00%
0/300
The same event may appear as both an adverse event (AE) and a serious adverse event (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.
|
0.33%
1/300
The same event may appear as both an adverse event (AE) and a serious adverse event (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%
0/309
The same event may appear as both an adverse event (AE) and a serious adverse event (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.
|
|
Psychiatric disorders
Abnormal behaviour
|
0.33%
1/300
The same event may appear as both an adverse event (AE) and a serious adverse event (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%
0/300
The same event may appear as both an adverse event (AE) and a serious adverse event (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%
0/309
The same event may appear as both an adverse event (AE) and a serious adverse event (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.
|
|
Psychiatric disorders
Depressive symptom
|
0.33%
1/300
The same event may appear as both an adverse event (AE) and a serious adverse event (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%
0/300
The same event may appear as both an adverse event (AE) and a serious adverse event (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%
0/309
The same event may appear as both an adverse event (AE) and a serious adverse event (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.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/300
The same event may appear as both an adverse event (AE) and a serious adverse event (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.
|
0.33%
1/300
The same event may appear as both an adverse event (AE) and a serious adverse event (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.
|
0.32%
1/309
The same event may appear as both an adverse event (AE) and a serious adverse event (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
| Measure |
Placebo
n=300 participants at risk
Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
|
DVS SR 50 mg
n=300 participants at risk
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.
|
DVS SR 100 mg
n=309 participants at risk
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.
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
8.0%
24/300
The same event may appear as both an adverse event (AE) and a serious adverse event (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.
|
16.0%
48/300
The same event may appear as both an adverse event (AE) and a serious adverse event (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.
|
16.8%
52/309
The same event may appear as both an adverse event (AE) and a serious adverse event (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
Fatigue
|
2.3%
7/300
The same event may appear as both an adverse event (AE) and a serious adverse event (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.
|
3.3%
10/300
The same event may appear as both an adverse event (AE) and a serious adverse event (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.
|
5.5%
17/309
The same event may appear as both an adverse event (AE) and a serious adverse event (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.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.7%
5/300
The same event may appear as both an adverse event (AE) and a serious adverse event (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.
|
4.0%
12/300
The same event may appear as both an adverse event (AE) and a serious adverse event (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.
|
5.8%
18/309
The same event may appear as both an adverse event (AE) and a serious adverse event (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
Dizziness
|
4.7%
14/300
The same event may appear as both an adverse event (AE) and a serious adverse event (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.
|
9.3%
28/300
The same event may appear as both an adverse event (AE) and a serious adverse event (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.
|
10.4%
32/309
The same event may appear as both an adverse event (AE) and a serious adverse event (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
Headache
|
10.7%
32/300
The same event may appear as both an adverse event (AE) and a serious adverse event (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.
|
19.0%
57/300
The same event may appear as both an adverse event (AE) and a serious adverse event (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.
|
19.7%
61/309
The same event may appear as both an adverse event (AE) and a serious adverse event (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
Somnolence
|
4.0%
12/300
The same event may appear as both an adverse event (AE) and a serious adverse event (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.
|
5.7%
17/300
The same event may appear as both an adverse event (AE) and a serious adverse event (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.
|
5.2%
16/309
The same event may appear as both an adverse event (AE) and a serious adverse event (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.
|
|
Psychiatric disorders
Insomnia
|
3.7%
11/300
The same event may appear as both an adverse event (AE) and a serious adverse event (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.
|
6.7%
20/300
The same event may appear as both an adverse event (AE) and a serious adverse event (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.
|
8.1%
25/309
The same event may appear as both an adverse event (AE) and a serious adverse event (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
Constipation
|
3.7%
11/300
The same event may appear as both an adverse event (AE) and a serious adverse event (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.
|
5.7%
17/300
The same event may appear as both an adverse event (AE) and a serious adverse event (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.
|
3.9%
12/309
The same event may appear as both an adverse event (AE) and a serious adverse event (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
Diarrhoea
|
6.0%
18/300
The same event may appear as both an adverse event (AE) and a serious adverse event (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.
|
8.7%
26/300
The same event may appear as both an adverse event (AE) and a serious adverse event (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.
|
6.1%
19/309
The same event may appear as both an adverse event (AE) and a serious adverse event (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
Dry mouth
|
8.0%
24/300
The same event may appear as both an adverse event (AE) and a serious adverse event (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.
|
10.3%
31/300
The same event may appear as both an adverse event (AE) and a serious adverse event (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.
|
12.0%
37/309
The same event may appear as both an adverse event (AE) and a serious adverse event (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.
|
Additional Information
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