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| ID | Type | Description | Link |
|---|---|---|---|
| 3151A6-3344 | Other Identifier | Alias Study Number | |
| 2008-001876-67 | EudraCT Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Desvenlafaxine Succinate Sustained-Release | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DVS SR | Drug | Subjects will receive a flexible-dose of 20, 25, 35, or 50 mg/day as prescribed by the investigator |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University Of Alabama At Birmingham, Office Of Psychiatric Research | Birmingham | Alabama | 35294-0009 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30419989 | Derived | Atkinson S, Thurman L, Ramaker S, Buckley G, Jones SR, England R, Wajsbrot D. Safety, Tolerability, and Efficacy of Desvenlafaxine in Children and Adolescents with Major Depressive Disorder: Results from Two Open-Label Extension Trials. CNS Spectr. 2019 Oct;24(5):496-506. doi: 10.1017/S1092852918001128. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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A total of 304 participants completed study B2061032, 283 of whom were enrolled in the current extension study, B2061030, and 281 received treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo/DVS-SR | Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030. |
| FG001 | DVS-SR, Low Dose/DVS-SR |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 |
| Center for Advanced Improvement |
| Tucson |
| Arizona |
| 85719 |
| United States |
| Sun Valley Research Center | Imperial | California | 92251 | United States |
| MCB Clinical Research Centers | Colorado Springs | Colorado | 80910 | United States |
| Institute of Living/Hartford Hospital | Hartford | Connecticut | 06106 | United States |
| SJS Clinical Research, Inc. | Destin | Florida | 32541 | United States |
| Sarkis Clinical Trials | Gainesville | Florida | 32607 | United States |
| Clinical Neuroscience Solutions | Jacksonville | Florida | 32256 | United States |
| Medical Research Group of Central Florida | Orange City | Florida | 32763 | United States |
| Millenia Psychiatry & Research, Inc. | Orlando | Florida | 32839 | United States |
| Janus Center for Psychiatric Research | West Palm Beach | Florida | 33407 | United States |
| Northwest Behavioral Research Center | Marietta | Georgia | 30060 | United States |
| Capstone Clinical Research | Libertyville | Illinois | 60048 | United States |
| Baber Research Group | Naperville | Illinois | 60563 | United States |
| Clinco | Terre Haute | Indiana | 47802 | United States |
| Pharmasite Research, Inc | Baltimore | Maryland | 21208 | United States |
| Millennium Psychiatric Associates, LLC | Creve Coeur | Missouri | 63141 | United States |
| Premier Psychiatric Research Institute, LLC | Lincoln | Nebraska | 68526 | United States |
| Erie County Medical Center/State University of New York (SUNY) at Buffalo Affiliate | Buffalo | New York | 14215 | United States |
| The Zucker Hillside Hospital, North Shore-Long Island Jewish Health System | Glen Oaks | New York | 11004 | United States |
| Bioscience Research, LLC. | Mount Kisco | New York | 10549 | United States |
| Finger Lakes Clinical Research | Rochester | New York | 14618 | United States |
| Stony Brook University Medical Center, child and Adolescent Psychiatry | Stony Brook | New York | 11794-8790 | United States |
| Neuro-Behavioral Clinical Research, Inc. | Canton | Ohio | 44718 | United States |
| Discovery and Wellness Center for Children/University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States |
| Sooner Clinical Research | Oklahoma City | Oklahoma | 73112 | United States |
| Research Strategies of Memphis, LLC. | Memphis | Tennessee | 38119 | United States |
| FutureSearch Trials | Austin | Texas | 78731 | United States |
| Clinical Trials of Texas, Inc. | San Antonio | Texas | 78229 | United States |
| Clinical Trials of Texas, INC | San Antonio | Texas | 78229 | United States |
| Allance Research Group | Richmond | Virginia | 23230 | United States |
| Alliance Research Group | Richmond | Virginia | 23230 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| Virginia Treatment Center for Children | Richmond | Virginia | 23298 | United States |
| Eastside Therapeutic Resource | Kirkland | Washington | 98033 | United States |
| Biomedica Research Group | Santiago | Santiago Metropolitan | 7500710 | Chile |
Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030. |
| FG002 | DVS-SR, High Dose/DVS-SR | Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030. |
| Received Treatment |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
All participants who received at least 1 dose of study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo/DVS-SR | Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030. |
| BG001 | DVS-SR, Low Dose/DVS-SR | Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030. |
| BG002 | DVS-SR, High Dose/DVS-SR | Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All participants who received at least 1 dose of study drug in study B2061030 | Posted | Number | Percentage of participants | From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 |
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| Primary | 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. | All participants who received at least 1 dose of study drug in study B2061030 | Posted | Number | Percentage of participants | From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 |
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| Secondary | 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. | All participants who had a CDRS-R evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, and had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030. | Posted | Mean | Standard Deviation | Units on a scale | From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 |
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| Secondary | 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. | All participants who had a CDRS-R evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030, and were available for evaluation. | Posted | Mean | Standard Deviation | Units on a scale | From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 |
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| Secondary | 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. | All participants who had a Children's Depression Rating Scale-Revised (CDRS-R) evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, and had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030. | Posted | Mean | Standard Deviation | Units on a scale | From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 |
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| Secondary | 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. | All participants who had a Children's Depression Rating Scale-Revised (CDRS-R) evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030, and were available for evaluation. | Posted | Mean | Standard Deviation | Units on a scale | From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 |
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| Secondary | 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. | All participants who had a Children's Depression Rating Scale-Revised (CDRS-R) evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, and had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030. | Posted | Number | Percentage of participants | From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 |
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| Secondary | 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. | All participants who had a Children's Depression Rating Scale-Revised (CDRS-R) evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030, and were available for evaluation. | Posted | Number | Percentage of participants | From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 |
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| Secondary | 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. | All participants who had a Children's Depression Rating Scale-Revised (CDRS-R) evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, and had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030. | Posted | Number | Percentage of participants | From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 |
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| Secondary | 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. | All participants who had a Children's Depression Rating Scale-Revised (CDRS-R) evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030, and were available for evaluation. | Posted | Number | Percentage of participants | From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 |
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| Secondary | 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. | All participants who had a CDRS-R evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, and had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030. | Posted | Number | Percentage of participants | From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 |
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| Secondary | 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. | All participants who had a CDRS-R evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030, and were available for evaluation. | Posted | Number | Percentage of participants | From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 |
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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,
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo/DVS-SR | Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030. | 4 | 91 | 60 | 91 | ||
| EG001 | DVS-SR, Low Dose/DVS-SR | Participants received DVS-SR in weight-based dosing(20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030. | 6 | 93 | 57 | 93 | ||
| EG002 | DVS-SR, High Dose/DVS-SR | Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030. | 3 | 97 | 58 | 97 | ||
| EG003 | Combination Group | Combination of 3 groups of participants from previous study B2061032 received DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030. | 13 | 281 | 175 | 281 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA v19 | Systematic Assessment |
| |
| Ketoacidosis | Metabolism and nutrition disorders | MedDRA v19 | Systematic Assessment |
| |
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA v19 | Systematic Assessment |
| |
| Aggression | Psychiatric disorders | MedDRA v19 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA v19 | Systematic Assessment |
| |
| Hallucination, auditory | Psychiatric disorders | MedDRA v19 | Systematic Assessment |
| |
| Initial insomnia | Psychiatric disorders | MedDRA v19 | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA v19 | Systematic Assessment |
| |
| Pyromania | Psychiatric disorders | MedDRA v19 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA v19 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA v19 | Systematic Assessment |
| |
| Suicide threat | Psychiatric disorders | MedDRA v19 | Systematic Assessment |
| |
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA v19 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v19 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v19 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v19 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v19 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v19 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v19 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v19 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA v19 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v19 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA v19 | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA v19 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v19 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v19 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA v19 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA v19 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA v19 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v19 | Systematic Assessment |
| |
| Increased appetite | Metabolism and nutrition disorders | MedDRA v19 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v19 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v19 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v19 | Systematic Assessment |
| |
| Psychomotor hyperactivity | Nervous system disorders | MedDRA v19 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA v19 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA v19 | Systematic Assessment |
| |
| Attention deficit/hyperactivity disorder | Psychiatric disorders | MedDRA v19 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA v19 | Systematic Assessment |
| |
| Initial insomnia | Psychiatric disorders | MedDRA v19 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v19 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA v19 | Systematic Assessment |
| |
| Self injurious behaviour | Psychiatric disorders | MedDRA v19 | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA v19 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v19 | Systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
| 12 to 17 years |
|
| Male |
|
| Black or African American |
|
| White |
|
| Other |
|
|
| DVS-SR, High Dose/DVS-SR |
Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030. |
|
|
|
Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
| OG002 | DVS-SR, High Dose/DVS-SR | Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030. |
|
|
| Units | Counts |
|---|
| Participants |
|
|
| DVS-SR, Low Dose/DVS-SR |
Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030. |
| OG002 | DVS-SR, High Dose/DVS-SR | Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030. |
|
|
|
|
Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030. |
| OG002 | DVS-SR, High Dose/DVS-SR | Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
|
|
|