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Trial Outcomes & Findings for Paroxetine-referenced Study Evaluating Three Doses of DVS SR in Outpatients With MDD (NCT NCT00445679)

NCT ID: NCT00445679

Last Updated: 2013-11-04

Results Overview

HAM-D17 is 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

807 participants

Primary outcome timeframe

8 weeks

Results posted on

2013-11-04

Participant Flow

Subjects were recruited in China, India, South Korea and Taiwan from July 2007 to December 2008.

After a 4 to 21 day screening period, eligible subjects were treated for up to 8 weeks.

Participant milestones

Participant milestones
Measure
DVS SR 50
Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
DVS SR 100
Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
DVS SR 200
Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
Paroxetine 20
Paroxetine 20 mg/day
Overall Study
STARTED
203
203
205
196
Overall Study
COMPLETED
155
157
139
149
Overall Study
NOT COMPLETED
48
46
66
47

Reasons for withdrawal

Reasons for withdrawal
Measure
DVS SR 50
Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
DVS SR 100
Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
DVS SR 200
Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
Paroxetine 20
Paroxetine 20 mg/day
Overall Study
Adverse Event
22
12
30
19
Overall Study
Failed to return
1
3
2
2
Overall Study
Physician Decision
0
0
1
0
Overall Study
Lost to Follow-up
10
6
6
5
Overall Study
Compliance
3
2
1
2
Overall Study
Withdrawal of Informed Consent
0
0
1
0
Overall Study
Protocol Violation
2
3
3
1
Overall Study
Withdrawal by Subject
8
14
20
18
Overall Study
Lack of Efficacy
2
6
2
0

Baseline Characteristics

Paroxetine-referenced Study Evaluating Three Doses of DVS SR in Outpatients With MDD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
DVS SR 50
n=203 Participants
Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
DVS SR 100
n=203 Participants
Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
DVS SR 200
n=205 Participants
Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
Paroxetine 20
n=196 Participants
Paroxetine 20 mg/day
Total
n=807 Participants
Total of all reporting groups
Age Continuous
38.63 years
STANDARD_DEVIATION 12.96 • n=5 Participants
39.26 years
STANDARD_DEVIATION 13.22 • n=7 Participants
39.26 years
STANDARD_DEVIATION 14.69 • n=5 Participants
38.27 years
STANDARD_DEVIATION 13.22 • n=4 Participants
38.86 years
STANDARD_DEVIATION 13.53 • n=21 Participants
Sex: Female, Male
Female
125 Participants
n=5 Participants
129 Participants
n=7 Participants
118 Participants
n=5 Participants
117 Participants
n=4 Participants
489 Participants
n=21 Participants
Sex: Female, Male
Male
78 Participants
n=5 Participants
74 Participants
n=7 Participants
87 Participants
n=5 Participants
79 Participants
n=4 Participants
318 Participants
n=21 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation.

HAM-D17 is 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.

Outcome measures

Outcome measures
Measure
DVS SR 50
n=200 Participants
Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
DVS SR 100
n=200 Participants
Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
DVS SR 200
n=197 Participants
Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
Paroxetine 20
n=192 Participants
Paroxetine 20 mg/day
Percentage of Responders With a 50% or Greater Decrease From Baseline on the Hamilton Rating Scale for Depression, 17-item (HAM-D17)
63 percentage of responders
67 percentage of responders
63 percentage of responders
66 percentage of responders

SECONDARY outcome

Timeframe: 8 weeks

Population: The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation. Number of participants analyzed reflects the final on-therapy population.

CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale, the clinician rates how much the subject's illness has improved or worsened relative to the baseline status (1= very much improved; 7= very much worse).

Outcome measures

Outcome measures
Measure
DVS SR 50
n=200 Participants
Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
DVS SR 100
n=200 Participants
Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
DVS SR 200
n=196 Participants
Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
Paroxetine 20
n=191 Participants
Paroxetine 20 mg/day
Clinical Global Impressions Scale-Improvement (CGI-I) Scores
Final - Score 6 (Much worse)
4 subjects
1 subjects
0 subjects
2 subjects
Clinical Global Impressions Scale-Improvement (CGI-I) Scores
Final - Score 1 (Very much improved)
72 subjects
78 subjects
79 subjects
72 subjects
Clinical Global Impressions Scale-Improvement (CGI-I) Scores
Final - Score 2 (Much improved)
64 subjects
64 subjects
53 subjects
59 subjects
Clinical Global Impressions Scale-Improvement (CGI-I) Scores
Final - Score 3 (Minimally improved)
36 subjects
34 subjects
28 subjects
37 subjects
Clinical Global Impressions Scale-Improvement (CGI-I) Scores
Final - Score 4 (No change)
16 subjects
17 subjects
26 subjects
17 subjects
Clinical Global Impressions Scale-Improvement (CGI-I) Scores
Final - Score 5 (Minimally worse)
8 subjects
6 subjects
10 subjects
4 subjects
Clinical Global Impressions Scale-Improvement (CGI-I) Scores
Final - Score 7 (Very Much worse)
0 subjects
0 subjects
0 subjects
0 subjects

SECONDARY outcome

Timeframe: 8 weeks

Population: The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation. Number of participants analyzed reflects the final on-therapy population.

CGI-S is a global rating scale that measures the severity of a subject's disease. Using a 7-point scale, the clinician rates the severity of the patient's mental illness at the time of the assessment, relative to the clinician's experience with subjects who have the same diagnosis (1= normal, not at all ill; 7= among the most extremely ill).

Outcome measures

Outcome measures
Measure
DVS SR 50
n=200 Participants
Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
DVS SR 100
n=200 Participants
Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
DVS SR 200
n=197 Participants
Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
Paroxetine 20
n=192 Participants
Paroxetine 20 mg/day
Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores
Final - Score 7 (Among the most extremely ill)
0 subjects
1 subjects
0 subjects
1 subjects
Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores
Final - Score 4 (Moderately ill)
29 subjects
30 subjects
38 subjects
27 subjects
Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores
Final - Score 1 (Normal, not at all ill)
40 subjects
50 subjects
53 subjects
42 subjects
Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores
Final - Score 2 (Borderline mentally ill)
49 subjects
53 subjects
47 subjects
49 subjects
Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores
Final - Score 3 (Mildly ill)
53 subjects
46 subjects
34 subjects
51 subjects
Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores
Final - Score 5 (Markedly ill)
24 subjects
18 subjects
19 subjects
15 subjects
Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores
Final - Score 6 (Severely ill)
5 subjects
2 subjects
6 subjects
7 subjects

SECONDARY outcome

Timeframe: Baseline and 8 weeks

Population: The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation. Number of participants analyzed reflects the final on-therapy population.

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
DVS SR 50
n=193 Participants
Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
DVS SR 100
n=193 Participants
Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
DVS SR 200
n=192 Participants
Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
Paroxetine 20
n=185 Participants
Paroxetine 20 mg/day
Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Mean Change From Baseline
-16.84 units on a scale
Interval -18.37 to -15.31
-17.84 units on a scale
Interval -19.37 to -16.31
-16.81 units on a scale
Interval -18.43 to -15.2
-16.54 units on a scale
Interval -18.08 to -15.0

SECONDARY outcome

Timeframe: 8 weeks

Population: The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation. Number of participants analyzed reflects the final on-therapy population.

The VAS-PI is a self-rated visual analog scale for the assessment of pain. Scores on the VAS-PI range from 0 (no pain) to 10 (worst possible pain). A decrease in VAS-PI overall scores indicates a subject's assessment of an improvement in pain.

Outcome measures

Outcome measures
Measure
DVS SR 50
n=192 Participants
Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
DVS SR 100
n=192 Participants
Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
DVS SR 200
n=191 Participants
Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
Paroxetine 20
n=185 Participants
Paroxetine 20 mg/day
Visual Analog Scale-pain Intensity (VAS-PI) Score Mean Change From Baseline
-11.69 scores on a scale
Interval -15.1 to -8.27
-10.00 scores on a scale
Interval -13.75 to -6.26
-9.10 scores on a scale
Interval -12.75 to -5.45
-9.52 scores on a scale
Interval -12.4 to -6.63

SECONDARY outcome

Timeframe: 8 weeks

Population: The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation. Number of participants analyzed reflects the final on-therapy population.

HAM-D6: standardized, clinician-administered rating scale is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 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). Total score ranges from 0 to 22; higher score indicates more depression.

Outcome measures

Outcome measures
Measure
DVS SR 50
n=200 Participants
Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
DVS SR 100
n=200 Participants
Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
DVS SR 200
n=197 Participants
Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
Paroxetine 20
n=192 Participants
Paroxetine 20 mg/day
Hamilton Rating Scale for Depression, 6-item (HAM-D6) Score Mean Change From Baseline
-6.50 scores on a scale
Interval -7.08 to -5.92
-6.51 scores on a scale
Interval -7.06 to -5.95
-6.42 scores on a scale
Interval -7.03 to -5.82
-6.58 scores on a scale
Interval -7.15 to -6.01

SECONDARY outcome

Timeframe: 8 weeks

Population: The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation. Number of participants analyzed reflects the final on-therapy population.

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, 5 = Very much. Total score ranges from 3 to 15; higher score indicates more anxiety.

Outcome measures

Outcome measures
Measure
DVS SR 50
n=193 Participants
Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
DVS SR 100
n=193 Participants
Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
DVS SR 200
n=192 Participants
Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
Paroxetine 20
n=185 Participants
Paroxetine 20 mg/day
Covi Anxiety Scale Score Mean Change From Baseline
-1.23 scores on a scale
Interval -1.47 to -0.99
-1.28 scores on a scale
Interval -1.54 to -1.03
-1.17 scores on a scale
Interval -1.44 to -0.89
-1.24 scores on a scale
Interval -1.49 to -1.0

Adverse Events

DVS SR 50

Serious events: 4 serious events
Other events: 128 other events
Deaths: 0 deaths

DVS SR 100

Serious events: 1 serious events
Other events: 128 other events
Deaths: 0 deaths

DVS SR 200

Serious events: 5 serious events
Other events: 140 other events
Deaths: 0 deaths

Paroxetine 20

Serious events: 2 serious events
Other events: 134 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
DVS SR 50
n=203 participants at risk
Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
DVS SR 100
n=203 participants at risk
Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
DVS SR 200
n=205 participants at risk
Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
Paroxetine 20
n=196 participants at risk
Paroxetine 20 mg/day
Gastrointestinal disorders
Cholelithiasis
0.00%
0/203
0.49%
1/203
0.00%
0/205
0.00%
0/196
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumor benign
0.49%
1/203
0.00%
0/203
0.00%
0/205
0.00%
0/196
Injury, poisoning and procedural complications
Intentional overdose
0.00%
0/203
0.00%
0/203
0.49%
1/205
0.00%
0/196
Psychiatric disorders
Suicide attempt
0.99%
2/203
0.00%
0/203
0.98%
2/205
0.51%
1/196
Psychiatric disorders
Mania
0.49%
1/203
0.00%
0/203
0.49%
1/205
0.00%
0/196
Psychiatric disorders
Suicidal behavior
0.00%
0/203
0.00%
0/203
0.98%
2/205
0.00%
0/196
Psychiatric disorders
Suicidal ideation
0.49%
1/203
0.00%
0/203
0.00%
0/205
1.0%
2/196
Psychiatric disorders
Drug abuse
0.00%
0/203
0.00%
0/203
0.00%
0/205
0.51%
1/196
Psychiatric disorders
Major Depressive Disorder worsening
0.00%
0/203
0.00%
0/203
0.00%
0/205
0.51%
1/196

Other adverse events

Other adverse events
Measure
DVS SR 50
n=203 participants at risk
Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
DVS SR 100
n=203 participants at risk
Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
DVS SR 200
n=205 participants at risk
Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
Paroxetine 20
n=196 participants at risk
Paroxetine 20 mg/day
Cardiac disorders
Palpitations
4.4%
9/203
3.4%
7/203
5.9%
12/205
5.1%
10/196
Gastrointestinal disorders
Constipation
9.4%
19/203
14.8%
30/203
9.8%
20/205
11.7%
23/196
Gastrointestinal disorders
Dry mouth
8.4%
17/203
7.9%
16/203
9.3%
19/205
6.1%
12/196
Gastrointestinal disorders
Nausea
14.8%
30/203
19.2%
39/203
20.0%
41/205
17.3%
34/196
General disorders
Asthenia
3.9%
8/203
2.5%
5/203
5.4%
11/205
3.1%
6/196
Infections and infestations
Nasopharyngitis
2.5%
5/203
3.9%
8/203
5.4%
11/205
6.6%
13/196
Metabolism and nutrition disorders
Anorexia
6.4%
13/203
6.9%
14/203
5.9%
12/205
7.1%
14/196
Nervous system disorders
Dizziness
14.8%
30/203
17.2%
35/203
12.7%
26/205
14.8%
29/196
Nervous system disorders
Headache
8.4%
17/203
9.9%
20/203
7.8%
16/205
7.1%
14/196
Nervous system disorders
Somnolence
6.4%
13/203
8.4%
17/203
5.4%
11/205
10.2%
20/196
Psychiatric disorders
Insomnia
13.3%
27/203
6.9%
14/203
9.3%
19/205
4.1%
8/196
Gastrointestinal disorders
Dyspepsia
5.9%
12/203
3.9%
8/203
2.9%
6/205
3.1%
6/196
Nervous system disorders
Sedation
2.0%
4/203
2.5%
5/203
4.4%
9/205
5.1%
10/196

Additional Information

U. S. Contact Center

Wyeth

Results disclosure agreements

  • Principal investigator is a sponsor employee The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.
  • Publication restrictions are in place

Restriction type: OTHER