A Phase 3 interventional study of Desvenlafaxine Succinate Sustained-Release (DVS SR) and Desvenlafaxine Succinate Sustained-Release (DVS SR) in Major Depressive Disorder, sponsored by Pfizer. Completed at 78 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-06-10.
Sponsored by Pfizer · Phase 3, Interventional, and Treatment
The primary purpose of this study is to compare the antidepressant efficacy and safety of two doses of DVS SR (25 and 50 mg/day) in the treatment of adults with Major Depressive Disorder. The study will also assess changes in sexual function and general and functional quality of life outcomes.
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's enrollment of 709 is above the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)
Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)
Drug: placebo
25 mg tablet, once daily dosing for 8 weeks
50 mg tablet, once daily dosing for 8 weeks
Matching placebo tablets (25 or 50 mg). Daily dosing for 10 +/- 4 days during a placebo lead-in period, and then 8 weeks during the double-blind period.
Change From Baseline in HAM-D17 Total Score at the Final On-therapy (FOT)Evaluation (Week 8 or ET)
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 ET)
Number of Participants With Categorical Scores on CGI-Improvement (CGI-I) at FOT Evaluation (Week 8 or ET)
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. Higher score = more affected.
Time frame: Week 8 (or ET)
Change From Baseline in Mean CGI-S Score at FOT Evaluation (Week 8 or ET)
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.
Time frame: Baseline and Week 8 (or ET)
Change From Baseline in MADRS Total Score at FOT Evaluation (Week 8 or ET)
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 ET)
Change From Baseline in HAM-D6 Total Score at FOT Evaluation (Week 8 or ET)
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 and all others are scored 0-4.
Time frame: Baseline and Week 8 (or ET)
Number of Participants With a Response on the HAM-D17 at FOT Evaluation (Week 8 or ET)
A HAM-D17 responder was defined as a participant with a 50% or greater decrease from baseline in HAM-D17 score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual 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: Week 8 (or ET)
Number of Participants in Remission Based on the HAM-D17 at FOT Evaluation (Week 8 or ET)
Remission was defined as a HAM-D17 score of less than or equal to 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual 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: Week 8 (or ET)
Number of Participants With a Response on the MADRS Score at FOT Evaluation (Week 8 or ET)
A MADRS responder was defined as a participant with a 50% or greater decrease from baseline in MADRS score. It 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: Week 8 (or ET)
Number of Participants With a Response on the CGI-I Score at FOT Evaluation (Week 8 or ET)
CGI-I responder was defined as a participant with a score of 1 (very much improved) or 2 (much improved) on the CGI-I. 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. Higher score = more affected.
Time frame: Week 8 (or ET)
Population Pharmacokinetics for Desvenlafaxine Plasma Concentrations
Relationship of demographic variables (age, gender, food, race, creatinine, aspartate aminotransaminase, alanine transaminase, bilirubin and concomitant medications) were examined by fitting measured DVS plasma concentrations to a 1 compartment model with first order absorption. Demographic variables were examined for clearance (CL/F), volume of distribution (V/F), Steady Area under Curve (AUC) using nonlinear mixed effects modeling. Final parameter estimates for demographic factors effecting CL/F, V/F and AUC were determined.
Time frame: Week 2, 4 and 8 (or ET)
Change From Baseline in SDS at FOT Evaluation (Week 8 or ET)
SDS: a self-administered tool that measures functional impairment in 3 domains: Work/School, Social Life, and Family Life/Home Responsibilities. The participant rates the extent to which each of these domains is impaired by his/her symptoms using a 10 point visual analog scale: (0=not at all impaired, 10=extremely impaired) for a total maximum score of 30.
Time frame: Baseline and Week 8 (or ET)
Change From Baseline in WHO-5 Total Score at FOT Evaluation (Week 8 or ET)
WHO-5 evaluates positive psychological well-being. WHO-5 consists of 5 questions and each is rated on a 6-point scale. The total score ranges from 0 to 25 (0= worst possible quality of life; 25=best possible quality of life).
Time frame: Baseline and Week 8 (or ET)
Percentage of Participants With Sexual Dysfunction at FOT Evaluation (Week 8 or ET)
ASEX scale includes 5 questions that evaluate sexual function exclusively during the week prior to completion in the following areas: libido, excitability and ability to reach orgasm. Sexual dysfunction=an ASEX total score of 19 or greater, or a score of 5 or greater on any item, or a score of 4 or greater on any 3 items. Participants who have had no sexual activity during the prior week should be instructed to not complete questions 3 through 5.
Time frame: Week 8 (or ET)
Number of Participants With Categorical Scores on the C-SSRS at FOT Evaluation (Week 8 or ET)
C-SSRS mapped into C-CASA(1-7) to assess whether participant:completed suicide(1),suicide attempt(2)(response of "Yes" on "Actual Attempt"),preparatory acts toward imminent suicidal behavior (3)("Yes" on "Preparatory Acts or Behavior"),suicidal ideation (4)("Yes" on "Wish to be dead","Non-Specific Active Suicidal Thoughts","Active Suicidal Ideation with methods without Intent to Act or Some Intent to Act,without Specific Plan or with Specific Plan and Intent),any suicidal behavior or ideation,self-injurious behaviour(7)("Yes" on "Has subject engaged in Non-suicidal Self-Injurious Behavior").
Time frame: Week 8 (or ET)
Discontinuation-Emergent Signs and Symptoms (DESS) Total Score
DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of "new symptoms" and "old (but worse) symptoms" (1) and 0 for "old and unchanged symptom," "absent," or "old symptom but improved" for a total possible range of 0 to 43. A higher score indicates more symptoms.
Time frame: Week 8 to 10 (or ET)
| Milestone | Placebo | DVS SR 25 mg | DVS SR 50 mg |
|---|---|---|---|
| Started | 235 | 237 | 237 |
| Treated | 231 | 232 | 236 |
| Completed | 209 | 204 | 215 |
| Not completed | 26 | 33 | 22 |
| Withdrew: Adverse event | 6 | 8 | 8 |
| Withdrew: Failed to return | 2 | 2 | 0 |
| Withdrew: Investigator | 0 | 1 | 2 |
| Withdrew: Lack of efficacy | 2 | 2 | 1 |
| Withdrew: Lost to follow-up | 5 | 6 | 6 |
| Withdrew: Other | 0 | 1 | 0 |
| Withdrew: Protocol violation | 4 | 0 | 2 |
| Withdrew: Withdrawal by subject | 3 | 8 | 2 |
| Withdrew: Randomized not treated | 4 | 5 | 1 |
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.
| Units on a scale | Placebo | DVS SR 25 mg | DVS SR 50 mg |
|---|---|---|---|
| Change From Baseline in HAM-D17 Total Score at the Final On-therapy (FOT)Evaluation (Week 8 or ET) | -8.52 ± 0.44 | -8.98 ± 0.44 | -10.02 ± 0.44 |
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. Higher score = more affected.
| Participants | Placebo | DVS SR 25 mg | DVS SR 50 mg |
|---|---|---|---|
| 1=Very much improved | 48 | 57 | 68 |
| 2=Much improved | 61 | 61 | 62 |
| 3=Minimally improved | 62 | 70 | 61 |
| 4=No change | 52 | 37 | 36 |
| 5=Minimally worse | 4 | 5 | 4 |
| 6=Much worse | 3 | 1 | 5 |
| 7=Very much worse | 1 | 1 | 0 |
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.
| Units on a scale | Placebo | DVS SR 25 mg | DVS SR 50 mg |
|---|---|---|---|
| Change From Baseline in Mean CGI-S Score at FOT Evaluation (Week 8 or ET) | -1.03 ± 0.07 | -1.22 ± 0.07 | -1.24 ± 0.07 |
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).
| Units on a scale | Placebo | DVS SR 25 mg | DVS SR 50 mg |
|---|---|---|---|
| Change From Baseline in MADRS Total Score at FOT Evaluation (Week 8 or ET) | -9.23 ± 0.61 | -10.23 ± 0.60 | -11.29 ± 0.60 |
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 and all others are scored 0-4.
| Units on a scale | Placebo | DVS SR 25 mg | DVS SR 50 mg |
|---|---|---|---|
| Change From Baseline in HAM-D6 Total Score at FOT Evaluation (Week 8 or ET) | -4.94 ± 0.26 | -5.03 ± 0.26 | -5.65 ± 0.25 |
A HAM-D17 responder was defined as a participant with a 50% or greater decrease from baseline in HAM-D17 score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual 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.
| Participants | Placebo | DVS SR 25 mg | DVS SR 50 mg |
|---|---|---|---|
| Number of Participants With a Response on the HAM-D17 at FOT Evaluation (Week 8 or ET) | 80 | 97 | 109 |
Remission was defined as a HAM-D17 score of less than or equal to 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual 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.
| Participants | Placebo | DVS SR 25 mg | DVS SR 50 mg |
|---|---|---|---|
| Number of Participants in Remission Based on the HAM-D17 at FOT Evaluation (Week 8 or ET) | 44 | 40 | 62 |
A MADRS responder was defined as a participant with a 50% or greater decrease from baseline in MADRS score. It 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).
| Participants | Placebo | DVS SR 25 mg | DVS SR 50 mg |
|---|---|---|---|
| Number of Participants With a Response on the MADRS Score at FOT Evaluation (Week 8 or ET) | 68 | 81 | 102 |
CGI-I responder was defined as a participant with a score of 1 (very much improved) or 2 (much improved) on the CGI-I. 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. Higher score = more affected.
| Participants | Placebo | DVS SR 25 mg | DVS SR 50 mg |
|---|---|---|---|
| Number of Participants With a Response on the CGI-I Score at FOT Evaluation (Week 8 or ET) | 109 | 118 | 130 |
Relationship of demographic variables (age, gender, food, race, creatinine, aspartate aminotransaminase, alanine transaminase, bilirubin and concomitant medications) were examined by fitting measured DVS plasma concentrations to a 1 compartment model with first order absorption. Demographic variables were examined for clearance (CL/F), volume of distribution (V/F), Steady Area under Curve (AUC) using nonlinear mixed effects modeling. Final parameter estimates for demographic factors effecting CL/F, V/F and AUC were determined.
No measurements were reported for this outcome.
SDS: a self-administered tool that measures functional impairment in 3 domains: Work/School, Social Life, and Family Life/Home Responsibilities. The participant rates the extent to which each of these domains is impaired by his/her symptoms using a 10 point visual analog scale: (0=not at all impaired, 10=extremely impaired) for a total maximum score of 30.
| Units on a scale | Placebo | DVS SR 25 mg | DVS SR 50 mg |
|---|---|---|---|
| Total Score (n=227,224,235) | -2.17 ± 0.43 | -3.26 ± 0.43 | -3.23 ± 0.42 |
| Work/Studies Component (n=227,225,235) | -0.77 ± 0.16 | -1.07 ± 0.15 | -1.12 ± 0.15 |
| Social Life Component (n=229,231,235) | -0.86 ± 0.16 | -1.26 ± 0.15 | -1.21 ± 0.15 |
| Family Life/Home Responsibilities (n=14,2,13) | -0.54 ± 0.88 | -1.83 ± 2.12 | -0.97 ± 0.89 |
WHO-5 evaluates positive psychological well-being. WHO-5 consists of 5 questions and each is rated on a 6-point scale. The total score ranges from 0 to 25 (0= worst possible quality of life; 25=best possible quality of life).
| Units on a scale | Placebo | DVS SR 25 mg | DVS SR 50 mg |
|---|---|---|---|
| Change From Baseline in WHO-5 Total Score at FOT Evaluation (Week 8 or ET) | 2.62 ± 0.31 | 3.43 ± 0.31 | 3.25 ± 0.31 |
ASEX scale includes 5 questions that evaluate sexual function exclusively during the week prior to completion in the following areas: libido, excitability and ability to reach orgasm. Sexual dysfunction=an ASEX total score of 19 or greater, or a score of 5 or greater on any item, or a score of 4 or greater on any 3 items. Participants who have had no sexual activity during the prior week should be instructed to not complete questions 3 through 5.
| Percentage of Participants | Placebo | DVS SR 25 mg | DVS SR 50 mg |
|---|---|---|---|
| Percentage of Participants With Sexual Dysfunction at FOT Evaluation (Week 8 or ET) | 55.0 | 52.7 | 55.8 |
C-SSRS mapped into C-CASA(1-7) to assess whether participant:completed suicide(1),suicide attempt(2)(response of "Yes" on "Actual Attempt"),preparatory acts toward imminent suicidal behavior (3)("Yes" on "Preparatory Acts or Behavior"),suicidal ideation (4)("Yes" on "Wish to be dead","Non-Specific Active Suicidal Thoughts","Active Suicidal Ideation with methods without Intent to Act or Some Intent to Act,without Specific Plan or with Specific Plan and Intent),any suicidal behavior or ideation,self-injurious behaviour(7)("Yes" on "Has subject engaged in Non-suicidal Self-Injurious Behavior").
| Participants | Placebo | DVS SR 25 mg | DVS SR 50 mg |
|---|---|---|---|
| Completed suicide | 0 | 0 | 0 |
| Suicide attempt | 0 | 0 | 1 |
| Preparatory acts toward imminent suicidal behavior | 0 | 0 | 0 |
| Suicidal ideation | 42 | 50 | 47 |
| Any suicidal behavior and/or ideation | 42 | 50 | 47 |
| Self-injurious behavior, no suicidal intent | 0 | 1 | 1 |
DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of "new symptoms" and "old (but worse) symptoms" (1) and 0 for "old and unchanged symptom," "absent," or "old symptom but improved" for a total possible range of 0 to 43. A higher score indicates more symptoms.
| Units on a scale | Placebo | DVS SR 25 mg | DVS SR 50 mg |
|---|---|---|---|
| Week 8 (or ET) (n=96,88,100) | 0.67 ± 1.62 | 0.63 ± 1.30 | 0.62 ± 1.53 |
| Week 9 (or ET + 1 week) (n=93,84,98) | 1.08 ± 2.68 | 1.38 ± 2.58 | 1.50 ± 2.81 |
| Week 10 (or ET + 2 weeks) (n=83,76,89) | 0.94 ± 2.28 | 0.74 ± 1.23 | 0.63 ± 1.60 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 3/231 (1.3%) | 158/231 (68.4%) |
| DVS SR 25 mg | — | 1/232 (0.4%) | 160/232 (69%) |
| DVS SR 50 mg | — | 5/236 (2.1%) | 174/236 (73.7%) |
| Event | Placebo | DVS SR 25 mg | DVS SR 50 mg |
|---|---|---|---|
| DepressionPsychiatric disorders | 1/231 | 0/232 | 2/236 |
| Grand mal convulsionNervous system disorders | 1/231 | 0/232 | 0/236 |
| PneumothoraxRespiratory, thoracic and mediastinal disorders | 1/231 | 0/232 | 0/236 |
| Post procedural complicationInjury, poisoning and procedural complications | 0/231 | 1/232 | 0/236 |
| Chest discomfortGeneral disorders | 0/231 | 0/232 | 1/236 |
| Peritonsillar abscessInfections and infestations | 0/231 | 0/232 | 1/236 |
| Pancreatic neuroendocrine tumour metastaticNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/231 | 0/232 | 1/236 |
| Hallucination, auditoryPsychiatric disorders | 0/231 | 0/232 | 1/236 |
| Homicidal ideationPsychiatric disorders | 0/231 | 0/232 | 1/236 |
| Suicidal ideationPsychiatric disorders | 0/231 | 0/232 | 1/236 |
| Event | Placebo | DVS SR 25 mg | DVS SR 50 mg |
|---|---|---|---|
| NasopharyngitisInfections and infestations | 37/231 | 26/232 | 30/236 |
| NauseaGastrointestinal disorders | 15/231 | 23/232 | 36/236 |
| HeadacheNervous system disorders | 25/231 | 23/232 | 28/236 |
| DizzinessNervous system disorders | 9/231 | 21/232 | 19/236 |
| DiarrhoeaGastrointestinal disorders | 14/231 | 15/232 | 14/236 |
| Dry mouthGastrointestinal disorders | 10/231 | 15/232 | 10/236 |
| SomnolenceNervous system disorders | 12/231 | 12/232 | 15/236 |
| ConstipationGastrointestinal disorders | 4/231 | 6/232 | 13/236 |
| Abnormal dreamsPsychiatric disorders | 10/231 | 9/232 | 12/236 |
| InsomniaPsychiatric disorders | 10/231 | 10/232 | 12/236 |
| Age Continuous(Years) | Placebo | DVS SR 25 mg | DVS SR 50 mg | Total |
|---|---|---|---|---|
| Mean | 40.26 ± 12.32 | 40.19 ± 11.88 | 38.59 ± 12.08 | 39.67 ± 12.10 |
| Sex: Female, Male(Participants) | Placebo | DVS SR 25 mg | DVS SR 50 mg | Total |
|---|---|---|---|---|
| Female | 128 | 127 | 131 | 386 |
| Male | 103 | 105 | 105 | 313 |
| Hamilton Psychiatric Scale for Depression-17 item (HAM-D17) total score(Units on a scale) | Placebo | DVS SR 25 mg | DVS SR 50 mg | Total |
|---|---|---|---|---|
| Mean | 23.06 ± 2.59 | 23.08 ± 2.93 | 22.81 ± 2.61 | 22.98 ± 2.71 |
| Clinical Global Impressions Scale-Severity of Illness (CGI-S) Score(Units on a scale) | Placebo | DVS SR 25 mg | DVS SR 50 mg | Total |
|---|---|---|---|---|
| Mean | 4.39 ± 0.59 | 4.35 ± 0.57 | 4.33 ± 0.56 | 4.36 ± 0.58 |
| Montgomery-Asberg Depression Rating Scale (MADRS) total score(Units on a scale) | Placebo | DVS SR 25 mg | DVS SR 50 mg | Total |
|---|---|---|---|---|
| Mean | 28.19 ± 5.74 | 28.08 ± 5.46 | 28.21 ± 5.38 | 28.16 ± 5.52 |
| HAM-D6 total score(Units on a scale) | Placebo | DVS SR 25 mg | DVS SR 50 mg | Total |
|---|---|---|---|---|
| Mean | 12.58 ± 1.79 | 12.61 ± 1.77 | 12.43 ± 1.75 | 12.54 ± 1.77 |
| Sheehan Disability Scale (SDS) Total Score(Units on a scale) | Placebo | DVS SR 25 mg | DVS SR 50 mg | Total |
|---|---|---|---|---|
| Mean | 16.31 ± 7.78 | 17.02 ± 7.34 | 16.39 ± 7.27 | 16.57 ± 7.46 |
| World Health Organization 5-Item Well-Being Index (WHO-5)(Units on a scale) | Placebo | DVS SR 25 mg | DVS SR 50 mg | Total |
|---|---|---|---|---|
| Mean | 7.21 ± 4.47 | 6.89 ± 3.99 | 7.18 ± 4.34 | 7.09 ± 4.27 |
2 further baseline measures are reported on the registry.
This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.
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