Trial Outcomes & Findings for Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) In The Treatment Of Peri- And Postmenopausal Women With Major Depressive Disorder (DVS 3364) (NCT NCT01121484)
NCT ID: NCT01121484
Last Updated: 2012-04-04
Results Overview
HAM-D17, clinician-rated interview, measures presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, \& weight loss). Total score ranges from 0 to 52; higher scores indicate more severe depression. Change from baseline: score at observation minus score at baseline.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
439 participants
Primary outcome timeframe
Baseline, Week 8
Results posted on
2012-04-04
Participant Flow
Participant milestones
| Measure |
Desvenlafaxine Succinate
Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
|
Placebo
Matching placebo tablets once daily for 10 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
218
|
221
|
|
Overall Study
Treated
|
217
|
217
|
|
Overall Study
COMPLETED
|
185
|
178
|
|
Overall Study
NOT COMPLETED
|
33
|
43
|
Reasons for withdrawal
| Measure |
Desvenlafaxine Succinate
Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
|
Placebo
Matching placebo tablets once daily for 10 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
12
|
5
|
|
Overall Study
Lack of Efficacy
|
3
|
11
|
|
Overall Study
Lost to Follow-up
|
5
|
9
|
|
Overall Study
Physician Decision
|
0
|
3
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
8
|
7
|
|
Overall Study
Discontinuation of study by sponsor
|
0
|
1
|
|
Overall Study
Other
|
3
|
3
|
|
Overall Study
Randomized, not treated
|
1
|
4
|
Baseline Characteristics
Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) In The Treatment Of Peri- And Postmenopausal Women With Major Depressive Disorder (DVS 3364)
Baseline characteristics by cohort
| Measure |
Desvenlafaxine Succinate
n=217 Participants
Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
|
Placebo
n=217 Participants
Matching placebo tablets once daily for 10 weeks
|
Total
n=434 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
53.1 Years
STANDARD_DEVIATION 6.85 • n=5 Participants
|
52.8 Years
STANDARD_DEVIATION 6.58 • n=7 Participants
|
53.0 Years
STANDARD_DEVIATION 6.71 • n=5 Participants
|
|
Sex: Female, Male
Female
|
217 Participants
n=5 Participants
|
217 Participants
n=7 Participants
|
434 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 8Population: Full Analysis Set (FAS) Population: randomized participants who had a baseline HAM-D17 score, took at least 1 dose of investigational product, and had at least 1 postbaseline HAM-D17 evaluation. Last Observation Carried Forward (LOCF).
HAM-D17, clinician-rated interview, measures presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, \& weight loss). Total score ranges from 0 to 52; higher scores indicate more severe depression. Change from baseline: score at observation minus score at baseline.
Outcome measures
| Measure |
Desvenlafaxine Succinate
n=216 Participants
Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
|
Placebo
n=216 Participants
Matching placebo tablets once daily for 10 weeks
|
|---|---|---|
|
Change From Baseline in Hamilton Depression Scale (HAM-D17) at Week 8
Baseline
|
22.8 Units on a scale
Standard Deviation 3.29
|
22.4 Units on a scale
Standard Deviation 3.51
|
|
Change From Baseline in Hamilton Depression Scale (HAM-D17) at Week 8
Change at Week 8
|
-9.7 Units on a scale
Standard Deviation 6.54
|
-7.4 Units on a scale
Standard Deviation 6.74
|
SECONDARY outcome
Timeframe: Week 8Population: FAS; LOCF
CGI-I: 7-point scale in which the clinician rated how much the participant's condition has changed compared to baseline. Scores ranged from 1 (very much improved) to 7 (very much worse). Improvement defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
Outcome measures
| Measure |
Desvenlafaxine Succinate
n=216 Participants
Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
|
Placebo
n=216 Participants
Matching placebo tablets once daily for 10 weeks
|
|---|---|---|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
Very Much Improved
|
51 participants
|
39 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
Much Improved
|
67 participants
|
37 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
Minimally Improved
|
53 participants
|
62 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
No Change
|
37 participants
|
69 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
Minimally Worse
|
6 participants
|
6 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
Much Worse
|
2 participants
|
3 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
Very Much Worse
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: FAS; LOCF
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 = more affected. Change: score at observation minus score at baseline.
Outcome measures
| Measure |
Desvenlafaxine Succinate
n=216 Participants
Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
|
Placebo
n=216 Participants
Matching placebo tablets once daily for 10 weeks
|
|---|---|---|
|
Change From Baseline in Clinical Global Impression - Severity (CGI-S) at Week 8
Baseline
|
4.4 Units on a scale
Standard Deviation 0.60
|
4.3 Units on a scale
Standard Deviation 0.53
|
|
Change From Baseline in Clinical Global Impression - Severity (CGI-S) at Week 8
Change at Week 8
|
-1.5 Units on a scale
Standard Deviation 1.20
|
-1.1 Units on a scale
Standard Deviation 1.24
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: FAS
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). Change: score at observation minus score at baseline.
Outcome measures
| Measure |
Desvenlafaxine Succinate
n=216 Participants
Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
|
Placebo
n=216 Participants
Matching placebo tablets once daily for 10 weeks
|
|---|---|---|
|
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score at Week 8
Baseline
|
31.0 Units on a scale
Standard Deviation 3.76
|
30.6 Units on a scale
Standard Deviation 3.83
|
|
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score at Week 8
Change at Week 8
|
-14.8 Units on a scale
Standard Deviation 9.09
|
-11.6 Units on a scale
Standard Deviation 9.99
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: FAS; LOCF
This is a 16-item self reported questionnaire that measures depressive symptoms. Improvement reported as change in depressive score. Score ranges from 0 to 42, with higher numbers indicating more severe symptom reporting. Change: score at observation minus score at baseline.
Outcome measures
| Measure |
Desvenlafaxine Succinate
n=216 Participants
Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
|
Placebo
n=216 Participants
Matching placebo tablets once daily for 10 weeks
|
|---|---|---|
|
Change From Baseline in Quick Inventory of Depressive Symptoms, 16 Question Self-report (QIDS-SR)
Baseline
|
15.1 Units on a scale
Standard Deviation 3.22
|
14.8 Units on a scale
Standard Deviation 3.60
|
|
Change From Baseline in Quick Inventory of Depressive Symptoms, 16 Question Self-report (QIDS-SR)
Change at Week 8
|
-5.9 Units on a scale
Standard Deviation 4.93
|
-5.2 Units on a scale
Standard Deviation 4.48
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: FAS; LOCF
10 centimeter (cm) line (Visual Analog Scale) marked by participant. Intensity of pain range (over past week): 0 = no pain to 10 = worst possible pain. Change: score at observation minus score at baseline.
Outcome measures
| Measure |
Desvenlafaxine Succinate
n=216 Participants
Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
|
Placebo
n=216 Participants
Matching placebo tablets once daily for 10 weeks
|
|---|---|---|
|
Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Week 8
Baseline
|
4.0 cm
Standard Deviation 2.90
|
4.0 cm
Standard Deviation 2.98
|
|
Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Week 8
Change at Week 8
|
-1.5 cm
Standard Deviation 2.69
|
-0.8 cm
Standard Deviation 2.72
|
Adverse Events
Desvenlafaxine Succinate
Serious events: 2 serious events
Other events: 100 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 90 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Desvenlafaxine Succinate
n=217 participants at risk
Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
|
Placebo
n=217 participants at risk
Matching placebo tablets once daily for 10 weeks
|
|---|---|---|
|
General disorders
Non-Cardiac Chest Pain
|
0.46%
1/217
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/217
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.00%
0/217
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.46%
1/217
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.00%
0/217
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.46%
1/217
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.46%
1/217
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/217
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Subarachnoid Haemorrhage
|
0.46%
1/217
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/217
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.46%
1/217
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/217
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Aneurysm Ruptured
|
0.46%
1/217
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/217
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Desvenlafaxine Succinate
n=217 participants at risk
Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
|
Placebo
n=217 participants at risk
Matching placebo tablets once daily for 10 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
7.8%
17/217
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
4.1%
9/217
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.0%
13/217
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.5%
12/217
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dry Mouth
|
6.5%
14/217
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.8%
17/217
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
11.1%
24/217
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.4%
16/217
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
6.9%
15/217
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.5%
12/217
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
7.8%
17/217
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
8.8%
19/217
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dizziness
|
6.5%
14/217
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
4.6%
10/217
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
15.2%
33/217
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
11.5%
25/217
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant 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