ClinicalTrials.gg
Sign In
CompletedNCT00384033Updated Mar 15, 2012Results posted

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

A Phase 3 interventional study of Desvenlafaxine Succinate Sustained-Release (DVS SR) and Desvenlafaxine Succinate Sustained-Release (DVS SR) in Depressive Disorder, Major, sponsored by Pfizer. Completed at 22 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-03-15.

Sponsored by Pfizer · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
638
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The primary purpose of this study is to evaluate the efficacy and safety of two doses of DVS SR (50 and 100 mg/day) in the treatment of adults with Major Depressive Disorder.

02

Conditions studied

  • Depressive Disorder, Major

Keywords

  • MDD
  • Major Depressive Disorder
  • Depression
03

In context

Depressive Disorder, Major

2,805 studies on the registry are indexed under Depressive Disorder, Major; 565 are open to participants now.

This study's enrollment of 638 is above the median of 80 across 2,338 interventional studies indexed under Depressive Disorder, Major.

Browse Depressive Disorder, Major studies →

Lead sponsor

Pfizer is the lead sponsor of 3,323 studies on the registry; 145 are open to participants now.

Of its 597 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.

Browse Pfizer studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • A primary diagnosis of Major Depressive Disorder, single or recurrent episode, without psychotic features.
  • Depressive symptoms for at least 30 days before the screening visit.
  • Outpatient men and women at least 18 years of age.

Exclusion criteria

Exclusion Criteria:

  • Significant risk of suicide based on clinical judgment, including common suicidal thoughts and suicide having been considered as a possible solution even without specific plans or intent.
  • Any unstable hepatic, renal, pulmonary, cardiovascular (including uncontrolled hypertension), ophthalmologic, neurologic, or any other medical condition that might confound the study or put the subject at greater risk during study participation.
  • Current (within 12 months before baseline) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder; b) current (within 12 months before baseline) generalized anxiety disorder, panic disorder, or social anxiety disorder; c) presence (within 12 months before baseline) of a clinically important personality disorder as assessed during the psychiatric assessments.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
638 participants (actual)

Study arms

  • Experimental
    Desvenlafaxine succinate sustained-release 50 mg

    Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)

  • Experimental
    Desvenlafaxine succinate sustained-release 100 mg

    Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)

  • Placebo comparator
    Placebo

    Drug: Placebo

  • Other
    Duloxetine 60mg

    Active control to assess assay sensitivity

    Drug: Duloxetine 60 mg/day

Interventions

06

What researchers measure

Primary outcomes

  1. Change From Baseline in HAM-D17 Total Score at Week 8 or Final On-therapy (FOT) Evaluation

    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.

    Time frame: Baseline and Week 8 or FOT

Secondary outcomes

  1. Number of Participants With Categorical Scores on CGI-Improvement (CGI-I) Score at Week 8 or FOT Evaluation

    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.

    Time frame: Week 8 or FOT

  2. Change From Baseline in Mean CGI-S Score at Week 8 or FOT Evaluation

    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.

    Time frame: Baseline and Week 8 or FOT

  3. Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score at Week 8 or FOT Evaluation

    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).

    Time frame: Baseline and Week 8 or FOT

  4. Change From Baseline in the Lassitude Item of the MADRS Scale at Week 8 or FOT Evaluation

    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.

    Time frame: Baseline and Week 8 or FOT

  5. Change From Baseline in HAM-D6 Total Score at Week 8 or FOT Evaluation

    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).

    Time frame: Baseline and Week 8 or FOT

  6. Change From Baseline in the HAM-D Energy Subscale Score at Week 8 or FOT Evaluation

    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).

    Time frame: Baseline and Week 8 or FOT

  7. Change From Baseline in Covi Anxiety Scale at Week 8 or FOT Evaluation

    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.

    Time frame: Baseline and Week 8 or FOT

  8. Change From Baseline in Visual Analog Scale-Pain Intensity (VAS-PI) Overall and Subcomponent Score at Week 8 or FOT Evaluation

    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.

    Time frame: Baseline and Week 8 or FOT

07

Results

Posted Mar 15, 2012

Participant flow

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

Participant flow — Overall Study
MilestonePlaceboDVS SR 50 mgDVS SR 100 mgDuloxetine 60 mg
Started164155160159
Treated161148150157
Completed123120117119
Not completed41354340
Withdrew: Adverse event1081120
Withdrew: Failed to return1322
Withdrew: Physician decision1000
Withdrew: Lost to follow-up61277
Withdrew: Other2000
Withdrew: Protocol violation5056
Withdrew: Withdrawal by subject6252
Withdrew: Lack of efficacy7331
Withdrew: Randomized but not treated37102

Outcome measures

PrimaryChange From Baseline in HAM-D17 Total Score at Week 8 or Final On-therapy (FOT) Evaluation

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.

Time frame:
Baseline and Week 8 or FOT
Reported as:
Mean · Units on a Scale
Change From Baseline in HAM-D17 Total Score at Week 8 or Final On-therapy (FOT) Evaluation
Units on a ScalePlaceboDVS SR 50 mgDVS SR 100 mgDuloxetine 60 mg
Change From Baseline in HAM-D17 Total Score at Week 8 or Final On-therapy (FOT) Evaluation-8.68 ± 0.58-9.75 ± 0.60-10.5 ± 0.60-10.3 ± 0.60
Statistical analysis
  • Placebo vs DVS SR 50 mg · ANCOVA · p = 0.198 (The analysis was done at a significance level of alpha = 0.05, 2-sided. Global F-test was used to adjust for multiplicity. If global F-test was significant at 0.05 level, pair wise analysis was interpreted without any further p-value adjustment.) · Mean difference (final values): 1.10 · 95% CI -0.60 to 2.70
  • Placebo vs DVS SR 100 mg · ANCOVA · p = 0.028 (The analysis was done at a significance level of alpha = 0.05, 2-sided. Global F-test was used to adjust for multiplicity. If global F-test was significant at 0.05 level, pair wise analysis was interpreted without any further p-value adjustment.) · Mean difference (final values): 1.80 · 95% CI 0.20 to 3.40
  • Placebo vs Duloxetine 60 mg · ANCOVA · p = 0.047 (The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.) · Mean difference (final values): 1.70 · 95% CI 0.00 to 3.40
SecondaryNumber of Participants With Categorical Scores on CGI-Improvement (CGI-I) Score at Week 8 or FOT Evaluation

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.

Time frame:
Week 8 or FOT
Reported as:
Number · Participants
Number of Participants With Categorical Scores on CGI-Improvement (CGI-I) Score at Week 8 or FOT Evaluation
ParticipantsPlaceboDVS SR 50 mgDVS SR 100 mgDuloxetine 60 mg
1 = Very much improved31274545
2 = Much improved32383735
3 = Minimally improved35472837
4 = No change57343737
5 = Minimally worse5223
Statistical analysis
  • Placebo vs DVS SR 50 mg · Cochran-Mantel-Haenszel · p = 0.110 (The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.)
  • Placebo vs DVS SR 100 mg · Cochran-Mantel-Haenszel · p = 0.009 (The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.)
  • Placebo vs Duloxetine 60 mg · Cochran-Mantel-Haenszel · p = 0.008 (The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.)
SecondaryChange From Baseline in Mean CGI-S Score at Week 8 or FOT Evaluation

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.

Time frame:
Baseline and Week 8 or FOT
Reported as:
Mean · Units on a Scale
Change From Baseline in Mean CGI-S Score at Week 8 or FOT Evaluation
Units on a ScalePlaceboDVS SR 50 mgDVS SR 100 mgDuloxetine 60 mg
Change From Baseline in Mean CGI-S Score at Week 8 or FOT Evaluation-1.10 ± 0.09-1.25 ± 0.10-1.44 ± 0.10-1.41 ± 0.10
Statistical analysis
  • Placebo vs DVS SR 50 mg · ANCOVA · p = 0.248 (The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.) · Mean difference (final values): 0.20 · 95% CI -0.10 to 0.40
  • Placebo vs DVS SR 100 mg · ANCOVA · p = 0.011 (The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.) · Mean difference (final values): 0.30 · 95% CI 0.10 to 0.60
  • Placebo vs Duloxetine 60 mg · ANCOVA · p = 0.026 (The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.) · Median difference (final values): 0.30 · 95% CI 0.00 to 0.60
SecondaryChange From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score at Week 8 or FOT Evaluation

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).

Time frame:
Baseline and Week 8 or FOT
Reported as:
Mean · Units on a Scale
Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score at Week 8 or FOT Evaluation
Units on a ScalePlaceboDVS SR 50 mgDVS SR 100 mgDuloxetine 60 mg
Baseline31.10 ± NA30.10 ± NA30.70 ± NA30.80 ± NA
Change at Week 8 or FOT-11.00 ± 0.82-12.70 ± 0.85-14.40 ± 0.84-14.40 ± 0.87
Statistical analysis
  • Placebo vs DVS SR 50 mg · ANCOVA · p = 0.149 (The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.) · Mean difference (final values): 1.70 · 95% CI -0.60 to 4.00
  • Placebo vs DVS SR 100 mg · ANCOVA · p = 0.004 (The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.) · Mean difference (final values): 3.30 · 95% CI 1.10 to 5.60
  • Placebo vs Duloxetine 60 mg · ANCOVA · p = 0.005 (The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.) · Mean difference (final values): 3.40 · 95% CI 1.10 to 5.80
SecondaryChange From Baseline in the Lassitude Item of the MADRS Scale at Week 8 or FOT Evaluation

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.

Time frame:
Baseline and Week 8 or FOT
Reported as:
Mean · Units on a Scale
Change From Baseline in the Lassitude Item of the MADRS Scale at Week 8 or FOT Evaluation
Units on a ScalePlaceboDVS SR 50 mgDVS SR 100 mgDuloxetine 60 mg
Baseline3.49 ± NA3.53 ± NA3.70 ± NA3.50 ± NA
Change at Week 8 or FOT-1.27 ± 0.12-1.39 ± 0.13-1.54 ± 0.13-1.26 ± 0.12
Statistical analysis
  • Placebo vs DVS SR 50 mg · ANCOVA · p = 0.473 (The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.) · Mean difference (final values): 0.12 · 95% CI -0.22 to 0.46
  • Placebo vs DVS SR 100 mg · ANCOVA · p = 0.119 (The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.) · Mean difference (final values): 0.27 · 95% CI -0.07 to 0.61
  • Placebo vs Duloxetine 60 mg · ANCOVA · p = 0.710 (The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.) · Mean difference (final values): 0.06 · 95% CI -0.27 to 0.40
SecondaryChange From Baseline in HAM-D6 Total Score at Week 8 or FOT Evaluation

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).

Time frame:
Baseline and Week 8 or FOT
Reported as:
Mean · Units on a Scale
Change From Baseline in HAM-D6 Total Score at Week 8 or FOT Evaluation
Units on a ScalePlaceboDVS SR 50 mgDVS SR 100 mgDuloxetine 60 mg
Baseline13.00 ± NA12.80 ± NA12.90 ± NA12.90 ± NA
Change at Week 8 or FOT-4.82 ± 0.33-5.41 ± 0.35-6.15 ± 0.34-5.91 ± 0.36
Statistical analysis
  • Placebo vs DVS SR 50 mg · ANCOVA · p = 0.215 (The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.) · Mean difference (final values): 0.60 · 95% CI -0.30 to 1.50
  • Placebo vs DVS SR 100 mg · ANCOVA · p = 0.005 (The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.) · Mean difference (final values): 1.30 · 95% CI 0.40 to 2.30
  • Placebo vs Duloxetine 60 mg · ANCOVA · p = 0.024 (The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.) · Mean difference (final values): 1.1 · 95% CI 0.20 to 2.10
SecondaryChange From Baseline in the HAM-D Energy Subscale Score at Week 8 or FOT Evaluation

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).

Time frame:
Baseline and Week 8 or FOT
Reported as:
Mean · Units on a Scale
Change From Baseline in the HAM-D Energy Subscale Score at Week 8 or FOT Evaluation
Units on a ScalePlaceboDVS SR 50 mgDVS SR 100 mgDuloxetine 60 mg
Baseline8.38 ± NA8.43 ± NA8.51 ± NA8.38 ± NA
Change at Week 8 or FOT-3.13 ± 0.23-3.66 ± 0.23-3.92 ± 0.23-3.80 ± 0.24
Statistical analysis
  • Placebo vs DVS SR 50 mg · ANCOVA · p = 0.100 (The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.) · Mean difference (final values): 0.53 · 95% CI -0.10 to 1.17
  • Placebo vs DVS SR 100 mg · ANCOVA · p = 0.014 (The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.) · Mean difference (final values): 0.79 · 95% CI 0.16 to 1.42
  • Placebo vs Duloxetine 60 mg · ANCOVA · p = 0.032 (The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.) · Mean difference (final values): 0.72 · 95% CI 0.06 to 1.38
SecondaryChange From Baseline in Covi Anxiety Scale at Week 8 or FOT Evaluation

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.

Time frame:
Baseline and Week 8 or FOT
Reported as:
Mean · Units on a Scale
Change From Baseline in Covi Anxiety Scale at Week 8 or FOT Evaluation
Units on a ScalePlaceboDVS SR 50 mgDVS SR 100 mgDuloxetine 60 mg
Baseline6.50 ± NA6.30 ± NA6.30 ± NA6.30 ± NA
Change at Week 8 or FOT-1.02 ± 0.12-1.15 ± 0.13-1.35 ± 0.13-1.47 ± 0.13
Statistical analysis
  • Placebo vs DVS SR 50 mg · ANCOVA · p = 0.445 (The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.) · Mean difference (final values): 0.10 · 95% CI -0.20 to 0.50
  • Placebo vs DVS SR 100 mg · ANCOVA · p = 0.056 (The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.) · Mean difference (final values): 0.30 · 95% CI -0.00 to 0.70
  • Placebo vs Duloxetine 60 mg · ANCOVA · p = 0.006 (The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.) · Median difference (final values): 0.50 · 95% CI 0.10 to 0.90
SecondaryChange From Baseline in Visual Analog Scale-Pain Intensity (VAS-PI) Overall and Subcomponent Score at Week 8 or FOT Evaluation

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.

Time frame:
Baseline and Week 8 or FOT
Reported as:
Mean · mm
Change From Baseline in Visual Analog Scale-Pain Intensity (VAS-PI) Overall and Subcomponent Score at Week 8 or FOT Evaluation
mmPlaceboDVS SR 50 mgDVS SR 100 mgDuloxetine 60 mg
Overall pain (Baseline)26.30 ± NA30.80 ± NA25.90 ± NA26.10 ± NA
Stomach pain (Baseline)16.70 ± NA19.40 ± NA17.00 ± NA14.00 ± NA
Back pain (Baseline)25.90 ± NA32.90 ± NA28.30 ± NA25.50 ± NA
Chest pain (Baseline)9.40 ± NA10.90 ± NA10.40 ± NA6.60 ± NA
Arms, legs or joint pain (Baseline)25.80 ± NA29.10 ± NA28.70 ± NA22.40 ± NA
Overall pain (Change at Week 8 or FOT)-5.61 ± 1.57-9.08 ± 1.64-10.30 ± 1.63-8.84 ± 1.74
Stomach pain (Change at Week 8 or FOT)-1.86 ± 1.62-4.98 ± 1.69-6.42 ± 1.68-4.38 ± 1.58
Back pain (Change at Week 8 or FOT)-7.04 ± 1.67-10.70 ± 1.74-12.80 ± 1.73-9.33 ± 1.83
Chest pain (Change at Week 8 or FOT)-1.95 ± 1.12-3.34 ± 1.17-3.90 ± 1.16-1.67 ± 1.21
Arms, legs or joint pain (Change at Week 8 or FOT)-6.99 ± 1.70-8.98 ± 1.76-11.90 ± 1.76-8.35 ± 1.64
Statistical analysis
  • Placebo vs DVS SR 50 mg · ANCOVA · p = 0.124 (The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.) · Mean difference (final values): 3.50 · 95% CI -0.90 to 7.90
  • Placebo vs DVS SR 100 mg · ANCOVA · p = 0.035 (The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.) · Mean difference (final values): 4.7 · 95% CI 0.30 to 9.10
  • Placebo vs Duloxetine 60 mg · ANCOVA · p = 0.093 (The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.) · Median difference (final values): 4.10 · 95% CI -0.70 to 8.80
  • Placebo vs DVS SR 50 mg · ANCOVA · p = 0.177 (The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.) · Mean difference (final values): 3.10 · 95% CI -1.40 to 7.70
  • Placebo vs DVS SR 100 mg · ANCOVA · p = 0.048 (The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.) · Mean difference (final values): 4.60 · 95% CI 0.10 to 9.10
  • Placebo vs Duloxetine 60 mg · ANCOVA · p = 0.088 (The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.) · Mean difference (final values): 3.80 · 95% CI -0.50 to 8.10
  • Placebo vs DVS SR 50 mg · ANCOVA · p = 0.122 (The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.) · Mean difference (final values): 3.70 · 95% CI -1.00 to 8.40
  • Placebo vs DVS SR 100 mg · ANCOVA · p = 0.015 (The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.) · Mean difference (final values): 5.80 · 95% CI 1.10 to 10.50
  • Placebo vs Duloxetine 60 mg · ANCOVA · p = 0.103 (The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.) · Mean difference (final values): 4.20 · 95% CI -0.80 to 9.20
  • Placebo vs DVS SR 50 mg · ANCOVA · p = 0.384 (The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.) · Mean difference (final values): 1.40 · 95% CI -1.70 to 4.50
  • Placebo vs DVS SR 100 mg · ANCOVA · p = 0.221 (The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.) · Mean difference (final values): 2.00 · 95% CI -1.20 to 5.10
  • Placebo vs Duloxetine 60 mg · ANCOVA · p = 0.411 (The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.) · Mean difference (final values): 1.40 · 95% CI -1.90 to 4.70
  • Placebo vs DVS SR 50 mg · ANCOVA · p = 0.412 (The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.) · Mean difference (final values): 2.00 · 95% CI -2.80 to 6.70
  • Placebo vs DVS SR 100 mg · ANCOVA · p = 0.042 (The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.) · Mean difference (final values): 4.90 · 95% CI 0.20 to 9.60
  • Placebo vs Duloxetine 60 mg · ANCOVA · p = 0.155 (The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.) · Mean difference (final values): 3.30 · 95% CI -1.20 to 7.80

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo—2/161 (1.2%)129/161 (80.1%)
DVS SR 50 mg—2/148 (1.4%)134/148 (90.5%)
DVS SR 100 mg—2/150 (1.3%)134/150 (89.3%)
Duloxetine 60 mg—1/157 (0.6%)141/157 (89.8%)
Most frequent serious events
Most frequent serious events
EventPlaceboDVS SR 50 mgDVS SR 100 mgDuloxetine 60 mg
Accidental injuryGeneral disorders1/1611/1480/1500/157
Suicidal ideationNervous system disorders0/1611/1480/1500/157
Gastrointestinal hemorrhageGastrointestinal disorders0/1610/1481/1500/157
MenorrhagiaRenal and urinary disorders0/1610/1481/1500/157
Suicide attemptGeneral disorders0/1610/1480/1501/157
AsthmaRespiratory, thoracic and mediastinal disorders1/1610/1480/1500/157
Most frequent other events
Showing 10 of 24
Most frequent other events
EventPlaceboDVS SR 50 mgDVS SR 100 mgDuloxetine 60 mg
NauseaGastrointestinal disorders22/16136/14840/15052/157
Withdrawal syndromeGeneral disorders24/16142/14842/15049/157
HeadacheGeneral disorders38/16127/14828/15030/157
InsomniaNervous system disorders9/16123/14828/15037/157
Dry mouthGastrointestinal disorders25/16126/14831/15033/157
SomnolenceNervous system disorders12/16116/14818/15033/157
AnorexiaGastrointestinal disorders7/16114/14814/15029/157
DizzinessNervous system disorders15/16115/14826/15027/157
DiarrheaGastrointestinal disorders22/16118/14824/15026/157
Upper respiratory infectionRespiratory, thoracic and mediastinal disorders20/16124/14820/15025/157

Baseline characteristics

Age Continuous
Age Continuous(Years)PlaceboDVS SR 50 mgDVS SR 100 mgDuloxetine 60 mgTotal
Mean39.24 ± 12.7440.67 ± 13.2038.77 ± 12.0738.94 ± 12.0139.39 ± 12.50
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboDVS SR 50 mgDVS SR 100 mgDuloxetine 60 mgTotal
Female9410299104399
Male67465153217
Hamilton psychiatric scale for depression-17 item (HAM-D17) total score
Hamilton psychiatric scale for depression-17 item (HAM-D17) total score(Units on a Scale)PlaceboDVS SR 50 mgDVS SR 100 mgDuloxetine 60 mgTotal
Mean23.86 ± 2.6823.49 ± 2.5223.49 ± 2.5522.99 ± 2.4523.46 ± 2.57
Clinical global impressions scale-severity (CGI-S) score
Clinical global impressions scale-severity (CGI-S) score(Units on a Scale)PlaceboDVS SR 50 mgDVS SR 100 mgDuloxetine 60 mgTotal
Mean4.39 ± 0.544.29 ± 0.484.31 ± 0.494.28 ± 0.464.32 ± 0.50
08

Study locations

22 sites
  • Pfizer Investigational Site
    Beverly Hills, California 90210, United States
  • Pfizer Investigational Site
    Burbank, California 91506, United States
  • Pfizer Investigational Site
    Encino, California 91316, United States
  • Pfizer Investigational Site
    Los Alamitos, California 90720, United States
  • Pfizer Investigational Site
    Newport Beach, California 92660, United States
  • Pfizer Investigational Site
    Northridge, California 91324, United States
  • Pfizer Investigational Site
    Orange, California 92868, United States
  • Pfizer Investigational Site
    Pasadena, California 91105, United States
  • Pfizer Investigational Site
    Upland, California 91786, United States
  • Pfizer Investigational Site
    South Miami, Florida 33143, United States
  • Pfizer Investigational Site
    St. Petersburg, Florida 33702, United States
  • Pfizer Investigational Site
    Edwardsville, Illinois 62025, United States
  • Pfizer Investigational Site
    Farmington Hills, Michigan 48336, United States
  • Pfizer Investigational Site
    Flint, Michigan 48507, United States
  • Pfizer Investigational Site
    Okemos, Michigan 48864, United States
  • Pfizer Investigational Site
    Clementon, New Jersey 08021, United States
  • Pfizer Investigational Site
    Dayton, Ohio 45408, United States
  • Pfizer Investigational Site
    Portland, Oregon 97210, United States
  • Pfizer Investigational Site
    Philadelphia, Pennsylvania 19149, United States
  • Pfizer Investigational Site
    Salt Lake City, Utah 84107, United States
  • Pfizer Investigational Site
    Seattle, Washington 98104, United States
  • Pfizer Investigational Site
    Brown Deer, Wisconsin 53223, United States
09

References and documents

Publications

  • Zilcha-Mano S, Wang X, Wajsbrot DB, Boucher M, Fine SA, Rutherford BR. Trajectories of Function and Symptom Change in Desvenlafaxine Clinical Trials: Toward Personalized Treatment for Depression. J Clin Psychopharmacol. 2021 Sep-Oct 01;41(5):579-584. doi: 10.1097/JCP.0000000000001435. PubMed 34183490 ↗
  • Soares CN, Zhang M, Boucher M. Categorical improvement in functional impairment in depressed patients treated with desvenlafaxine. CNS Spectr. 2019 Jun;24(3):322-332. doi: 10.1017/S1092852917000633. Epub 2017 Nov 15. PubMed 29140227 ↗
  • McIntyre RS, Fayyad R, Mackell JA, Boucher M. Effect of metabolic syndrome and thyroid hormone on efficacy of desvenlafaxine 50 and 100 mg/d in major depressive disorder. Curr Med Res Opin. 2016;32(3):587-99. doi: 10.1185/03007995.2015.1136603. Epub 2016 Jan 13. PubMed 26709542 ↗
  • McIntyre RS, Fayyad RS, Guico-Pabia CJ, Boucher M. A Post Hoc Analysis of the Effect of Weight on Efficacy in Depressed Patients Treated With Desvenlafaxine 50 mg/d and 100 mg/d. Prim Care Companion CNS Disord. 2015 Jun 4;17(3):10.4088/PCC.14m01741. doi: 10.4088/PCC.14m01741. eCollection 2015. PubMed 26644956 ↗
  • Thase ME, Fayyad R, Cheng RF, Guico-Pabia CJ, Sporn J, Boucher M, Tourian KA. Effects of desvenlafaxine on blood pressure in patients treated for major depressive disorder: a pooled analysis. Curr Med Res Opin. 2015 Apr;31(4):809-20. doi: 10.1185/03007995.2015.1020365. Epub 2015 Mar 26. PubMed 25758058 ↗
  • Soares CN, Endicott J, Boucher M, Fayyad RS, Guico-Pabia CJ. Predictors of functional response and remission with desvenlafaxine 50 mg/d in patients with major depressive disorder. CNS Spectr. 2014 Dec;19(6):519-27. doi: 10.1017/S1092852914000066. Epub 2014 Feb 26. PubMed 24571916 ↗
  • Tourian KA, Padmanabhan SK, Groark J, Brisard C, Farrington D. Desvenlafaxine 50 and 100 mg/d in the treatment of major depressive disorder: an 8-week, phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial and a post hoc pooled analysis of three studies. Clin Ther. 2009 Jun;31 Pt 1:1405-23. doi: 10.1016/j.clinthera.2009.07.006. PubMed 19698901 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 15, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00384033
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Oct 4, 2006
Start date
Sep 2006
Primary completion
Sep 2007
Completion
Sep 2007
Results posted
Mar 15, 2012
Last update
Mar 15, 2012

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Desvenlafaxine

Other studies in this condition

Depressive Disorder, Major →

Other studies from this sponsor

Pfizer →

Start the discussion