A Phase 3 interventional study of DVS SR in Major Depressive Disorder, sponsored by Pfizer. Completed at 36 sites in 2 countries. Open to participants aged 7 Years to 17 Years. Per ClinicalTrials.gov, last updated 2017-07-27.
Sponsored by Pfizer · Phase 3, Interventional, and Treatment
This is a 6-month, open-label, flexible-dose study evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) in the Treatment of Child and Adolescent Outpatients with Major Depressive Disorder (MDD).
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's enrollment of 283 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.
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Exclusion Criteria:
Drug: DVS SR
Subjects will receive a flexible-dose of 20, 25, 35, or 50 mg/day as prescribed by the investigator
Percentage of Participants With a Treatment-emergent Adverse Event (TEAE)
A TEAE was defined as an event that was absent before treatment and emerged or worsened during the treatment period.
Time frame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) (Combination Group)
A TEAE was defined as an event that was absent before treatment and emerged or worsened during the treatment period.
Time frame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases
The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total scores indicate lower intensity of symptoms. Remission on the CDRS-R was defined as a CDRS-R score \<=28. It was recommended that the CDRS-R be performed prior to the Clinical Global Impression assessments. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Time frame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases (Combination Group)
The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total scores indicate lower intensity of symptoms. Remission on the CDRS-R was defined as a CDRS-R score \<=28. It was recommended that the CDRS-R be performed prior to the Clinical Global Impression assessments. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Time frame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases
The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-S, which rates the severity of illness from 1 to 7, and the CGI-Improvement Scale, which assesses improvement in illness since baseline. The CGI-S is a 7-point scale a clinician uses to rate a patient's severity of illness. Scores range from 1 to 7, with 1 indicating "normal, not at all ill" and 7, "among the most extremely ill patients." Higher score on the CGI-S indicates greater severity of illness. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Time frame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases (Combination Group)
The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-S, which rates the severity of illness from 1 to 7, and the CGI-Improvement Scale, which assesses improvement in illness since baseline. The CGI-S is a 7-point scale a clinician uses to rate a patient's severity of illness. Scores range from 1 to 7, with 1 indicating "normal, not at all ill" and 7, "among the most extremely ill patients." Higher score on the CGI-S indicates greater severity of illness. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Time frame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Percentage of Participants With a Response of Very Much Improved or Much Improved on the Clinical Global Impression-Improvement (CGI-I) Scale at Week 26, Based on Observed Cases
The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing "very much improved" and 7 representing "very much worse"; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Time frame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Percentage of Participants With a Response of Very Much Improved or Much Improved on the Clinical Global Impression-Improvement (CGI-I) Scale at Week 26, Based on Observed Cases (Combination Group)
The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing "very much improved" and 7 representing "very much worse"; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Time frame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases
The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale used a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing "very much improved" and 7 representing "very much worse"; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Time frame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases (Combination Group)
The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale used a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing "very much improved" and 7 representing "very much worse"; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Time frame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Percentage of Participants With Remission at Week 26, Based on Score on the Children's Depression Rating Scale, Revised (CDRS-R), <=28 and on Observed Cases
Remission on the CDRS-R was defined as a CDRS-R score \<=28. The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total s cores indicate lower intensity of symptoms.
Time frame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Percentage of Participants With Remission at Week 26, Based on a Score on the Children's Depression Rating Scale, Revised (CDRS-R), <=28 and on Observed Cases (Combination Group)
Remission on the CDRS-R was defined as a CDRS-R score \<=28. The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total s cores indicate lower intensity of symptoms.
Time frame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
| Milestone | Placebo/DVS-SR | DVS-SR, Low Dose/DVS-SR | DVS-SR, High Dose/DVS-SR |
|---|---|---|---|
| Started | 92 | 93 | 98 |
| Received treatment | 91 | 93 | 97 |
| Completed | 66 | 63 | 59 |
| Not completed | 26 | 30 | 39 |
| Withdrew: Insufficient clinical response | 3 | 2 | 0 |
| Withdrew: Lost to follow-up | 5 | 9 | 7 |
| Withdrew: Protocol violation | 2 | 1 | 2 |
| Withdrew: No longer willing to participate | 7 | 7 | 13 |
| Withdrew: Medication error/not related to ae | 0 | 1 | 0 |
| Withdrew: Other | 3 | 2 | 4 |
| Withdrew: Adverse event | 5 | 8 | 12 |
| Withdrew: Started but did not receive treatment | 1 | 0 | 1 |
A TEAE was defined as an event that was absent before treatment and emerged or worsened during the treatment period.
| Percentage of participants | Placebo/DVS-SR | DVS-SR, Low Dose/DVS-SR | DVS-SR, High Dose/DVS-SR |
|---|---|---|---|
| Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) | 78.0 | 73.1 | 71.1 |
A TEAE was defined as an event that was absent before treatment and emerged or worsened during the treatment period.
| Percentage of participants | Combination Group |
|---|---|
| Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) (Combination Group) | 74.0 |
The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total scores indicate lower intensity of symptoms. Remission on the CDRS-R was defined as a CDRS-R score \<=28. It was recommended that the CDRS-R be performed prior to the Clinical Global Impression assessments. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
| Units on a scale | Placebo/DVS-SR | DVS-SR, Low Dose/DVS-SR | DVS-SR, High Dose/DVS-SR |
|---|---|---|---|
| Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases | -6.79 ± 12.05 | -10.72 ± 10.80 | -8.57 ± 13.01 |
The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total scores indicate lower intensity of symptoms. Remission on the CDRS-R was defined as a CDRS-R score \<=28. It was recommended that the CDRS-R be performed prior to the Clinical Global Impression assessments. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
| Units on a scale | Combination Group |
|---|---|
| Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases (Combination Group) | -8.63 ± 12.03 |
The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-S, which rates the severity of illness from 1 to 7, and the CGI-Improvement Scale, which assesses improvement in illness since baseline. The CGI-S is a 7-point scale a clinician uses to rate a patient's severity of illness. Scores range from 1 to 7, with 1 indicating "normal, not at all ill" and 7, "among the most extremely ill patients." Higher score on the CGI-S indicates greater severity of illness. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
| Units on a scale | Placebo/DVS-SR | DVS-SR, Low Dose/DVS-SR | DVS-SR, High Dose/DVS-SR |
|---|---|---|---|
| Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases | -1.02 ± 1.18 | -1.44 ± 1.12 | -0.70 ± 1.37 |
The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-S, which rates the severity of illness from 1 to 7, and the CGI-Improvement Scale, which assesses improvement in illness since baseline. The CGI-S is a 7-point scale a clinician uses to rate a patient's severity of illness. Scores range from 1 to 7, with 1 indicating "normal, not at all ill" and 7, "among the most extremely ill patients." Higher score on the CGI-S indicates greater severity of illness. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
| Units on a scale | Combination Group |
|---|---|
| Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases (Combination Group) | -1.05 ± 1.26 |
The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing "very much improved" and 7 representing "very much worse"; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
| Percentage of participants | Placebo/DVS-SR | DVS-SR, Low Dose/DVS-SR | DVS-SR, High Dose/DVS-SR |
|---|---|---|---|
| Percentage of Participants With a Response of Very Much Improved or Much Improved on the Clinical Global Impression-Improvement (CGI-I) Scale at Week 26, Based on Observed Cases | 87.3 | 94.7 | 89.3 |
The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing "very much improved" and 7 representing "very much worse"; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
| Percentage of participants | Combination Group |
|---|---|
| Percentage of Participants With a Response of Very Much Improved or Much Improved on the Clinical Global Impression-Improvement (CGI-I) Scale at Week 26, Based on Observed Cases (Combination Group) | 90.3 |
The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale used a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing "very much improved" and 7 representing "very much worse"; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
| Percentage of participants | Placebo/DVS-SR | DVS-SR, Low Dose/DVS-SR | DVS-SR, High Dose/DVS-SR |
|---|---|---|---|
| Week 26: Very much improved | 54.0 | 73.7 | 53.6 |
| Week 26: Much improved | 33.3 | 21.1 | 35.7 |
| Week 26: Minimally improved | 9.5 | 5.3 | 10.7 |
| Week 26: No change | 1.6 | 0.0 | 0.0 |
| Week 26: Minimally worse | 1.6 | 0.0 | 0.0 |
| Week 26: Much worse | 0.0 | 0.0 | 0.0 |
| Week 26: Very much worse | 0.0 | 0.0 | 0.0 |
The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale used a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing "very much improved" and 7 representing "very much worse"; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
| Percentage of participants | Combination Group |
|---|---|
| Week 26: Very much improved | 60.2 |
| Week 26: Much improved | 30.1 |
| Week 26: Minimally improved | 8.5 |
| Week 26: No change | 0.6 |
| Week 26: Minimally worse | 0.6 |
| Week 26: Much worse | 0.0 |
| Week 26: Very much worse | 0.0 |
Remission on the CDRS-R was defined as a CDRS-R score \<=28. The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total s cores indicate lower intensity of symptoms.
| Percentage of participants | Placebo/DVS-SR | DVS-SR, Low Dose/DVS-SR | DVS-SR, High Dose/DVS-SR |
|---|---|---|---|
| Percentage of Participants With Remission at Week 26, Based on Score on the Children's Depression Rating Scale, Revised (CDRS-R), <=28 and on Observed Cases | 73.0 | 89.5 | 75.0 |
Remission on the CDRS-R was defined as a CDRS-R score \<=28. The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total s cores indicate lower intensity of symptoms.
| Percentage of participants | Combination Group |
|---|---|
| Percentage of Participants With Remission at Week 26, Based on a Score on the Children's Depression Rating Scale, Revised (CDRS-R), <=28 and on Observed Cases (Combination Group) | 79.0 |
Collected over From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo/DVS-SR | — | 4/91 (4.4%) | 60/91 (65.9%) |
| DVS-SR, Low Dose/DVS-SR | — | 6/93 (6.5%) | 57/93 (61.3%) |
| DVS-SR, High Dose/DVS-SR | — | 3/97 (3.1%) | 58/97 (59.8%) |
| Combination Group | — | 13/281 (4.6%) | 175/281 (62.3%) |
| Event | Placebo/DVS-SR | DVS-SR, Low Dose/DVS-SR | DVS-SR, High Dose/DVS-SR | Combination Group |
|---|---|---|---|---|
| Suicidal ideationPsychiatric disorders | 2/91 | 1/93 | 2/97 | 5/281 |
| Suicide attemptPsychiatric disorders | 0/91 | 2/93 | 1/97 | 3/281 |
| AggressionPsychiatric disorders | 1/91 | 0/93 | 0/97 | 1/281 |
| AgitationPsychiatric disorders | 1/91 | 1/93 | 0/97 | 2/281 |
| Major depressionPsychiatric disorders | 1/91 | 0/93 | 0/97 | 1/281 |
| Suicide threatPsychiatric disorders | 1/91 | 0/93 | 0/97 | 1/281 |
| KetoacidosisMetabolism and nutrition disorders | 0/91 | 1/93 | 0/97 | 1/281 |
| Generalised tonic-clonic seizureNervous system disorders | 0/91 | 1/93 | 0/97 | 1/281 |
| Hallucination, auditoryPsychiatric disorders | 0/91 | 1/93 | 0/97 | 1/281 |
| Initial insomniaPsychiatric disorders | 0/91 | 1/93 | 0/97 | 1/281 |
| Event | Placebo/DVS-SR | DVS-SR, Low Dose/DVS-SR | DVS-SR, High Dose/DVS-SR | Combination Group |
|---|---|---|---|---|
| HeadacheNervous system disorders | 12/91 | 16/93 | 17/97 | 45/281 |
| NauseaGastrointestinal disorders | 4/91 | 11/93 | 6/97 | 21/281 |
| SomnolenceNervous system disorders | 10/91 | 3/93 | 1/97 | 14/281 |
| Upper respiratory tract infectionInfections and infestations | 4/91 | 10/93 | 2/97 | 16/281 |
| NasopharyngitisInfections and infestations | 9/91 | 4/93 | 8/97 | 21/281 |
| Accidental overdoseInjury, poisoning and procedural complications | 8/91 | 4/93 | 8/97 | 20/281 |
| Abdominal pain upperGastrointestinal disorders | 4/91 | 1/93 | 8/97 | 13/281 |
| Gastroenteritis viralInfections and infestations | 7/91 | 3/93 | 6/97 | 16/281 |
| InsomniaPsychiatric disorders | 7/91 | 6/93 | 4/97 | 17/281 |
| IrritabilityPsychiatric disorders | 3/91 | 4/93 | 7/97 | 14/281 |
All participants who received at least 1 dose of study drug
| Age, Customized(Participants) | Placebo/DVS-SR | DVS-SR, Low Dose/DVS-SR | DVS-SR, High Dose/DVS-SR | Total |
|---|---|---|---|---|
| 7 to 11 years | 28 | 26 | 33 | 87 |
| 12 to 17 years | 63 | 67 | 64 | 194 |
| Sex: Female, Male(Participants) | Placebo/DVS-SR | DVS-SR, Low Dose/DVS-SR | DVS-SR, High Dose/DVS-SR | Total |
|---|---|---|---|---|
| Female | 43 | 52 | 60 | 155 |
| Male | 48 | 41 | 37 | 126 |
| Race/Ethnicity, Customized(Participants) | Placebo/DVS-SR | DVS-SR, Low Dose/DVS-SR | DVS-SR, High Dose/DVS-SR | Total |
|---|---|---|---|---|
| Asian | 1 | 1 | 0 | 2 |
| Black or African American | 20 | 23 | 28 | 71 |
| White | 62 | 65 | 60 | 187 |
| Other | 8 | 4 | 9 | 21 |
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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