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| ID | Type | Description | Link |
|---|---|---|---|
| 3151A6-3343 | Other Identifier | Alias Study Number | |
| 2008-001875-32 | EudraCT Number |
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This is a double-blind study evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) versus placebo in the Treatment of Children and Adolescent Outpatients with Major Depressive Disorder (MDD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Arm 1 - high dose | Experimental |
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| Experimental Arm 2 - low dose | Experimental |
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| Placebo Arm | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Desvenlafaxine Succinate Sustained-Release | Drug | Subjects randomized to DVS SR treatment arm will receive 25, 35, or 50 mg/day based on subject weight at the Baseline visit. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score (n=102, 104, 106) | Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment. Mean change from baseline was adjusted for the baseline total score, age group and gender. | Baseline and Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score (n=102, 105, 106) | A 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. Change: score at observation minus score at baseline. Mean change from baseline was adjusted for the baseline total score, age group and gender. |
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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 |
|---|---|---|---|---|---|---|
| Children's Hospital of Alabama Laboratory | Birmingham | Alabama | 35233 | United States | ||
| The University of Alabama at Birmingham, Office of Psychiatric Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29185786 | Derived | Atkinson S, Lubaczewski S, Ramaker S, England RD, Wajsbrot DB, Abbas R, Findling RL. Desvenlafaxine Versus Placebo in the Treatment of Children and Adolescents with Major Depressive Disorder. J Child Adolesc Psychopharmacol. 2018 Feb;28(1):55-65. doi: 10.1089/cap.2017.0099. Epub 2017 Nov 29. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Matched placebo tablets administered once daily for 8 weeks (treatment phase), followed by placebo tablets administered once daily for 1 week (taper phase) only for those participants not entering the extension study. |
| FG001 | DVS SR Low Dose |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Desvenlafaxine Succinate Sustained-Release | Drug | Subjects randomized to DVS SR treatment arm will receive 20, 25, or 35 mg/day based on subject weight at the Baseline visit. |
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| Placebo | Drug | Subjects randomized to the Placebo treatment arm will receive placebo tablets |
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| Baseline and Week 8 |
| Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | A 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 equals (=) more affected. | Weeks 1, 2, 3, 4, 6, and 8 |
| Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved' | A 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) or 2 (much improved) on the scale. Higher score = more affected. | Weeks 1, 2, 3, 4, 6, and 8 |
| Birmingham |
| Alabama |
| 35294 |
| United States |
| 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 |
| Bliss Basement Pharmacy - Hartford Hospital | Hartford | Connecticut | 06102 | United States |
| Institute of Living/Hartford Hospital | Hartford | Connecticut | 06106 | United States |
| Institute of Living | 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 |
| AMR-Baber Research Inc. | Naperville | Illinois | 60563 | United States |
| Clinco | Terre Haute | Indiana | 47802 | United States |
| Louisiana State University Health Sciences Center-Psychopharmacology Research Clinic | Shreveport | Louisiana | 71103 | United States |
| Drug:University Health Shreveport Outpatient | Shreveport | Louisiana | 71130 | 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 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 |
| Alliance Research Group | Richmond | Virginia | 23230 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| Virginia Treatment Center | Richmond | Virginia | 23298 | United States |
| Carilion Medical Center | Roanoke | Virginia | 24014 | United States |
| Eastside Therapeutic Resource | Kirkland | Washington | 98033 | United States |
| Biomedica Research Group | Santiago | Santiago Metropolitan | 7500710 | Chile |
| Optima Salud | Santiago | Santiago Metropolitan | 8320325 | Chile |
| Hospital Universitario Dr. Jose Eleuterio Gonzalez, Departamento de Psiquiatria | Monterrey | Nuevo León | 064460 | Mexico |
DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 20, 25 or 35 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study. |
| FG002 | DVS SR High Dose | DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study. |
| COMPLETED |
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| NOT COMPLETED |
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Safety population - included all randomized participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Matched placebo tablets administered once daily for 8 weeks (treatment phase), followed by placebo tablets administered once daily for 1 week (taper phase) only for those participants not entering the extension study. |
| BG001 | DVS SR Low Dose | DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 20, 25 or 35 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study. |
| BG002 | DVS SR High Dose | DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score (n=102, 104, 106) | Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment. Mean change from baseline was adjusted for the baseline total score, age group and gender. | Intention-To-Treat (ITT) Population - included all randomized participants who received at least 1 dose of study drug, had a baseline primary efficacy assessment, and had at least one post-baseline primary efficacy assessment. n is the number of participants with evaluable data. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline and Week 8 |
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| Secondary | Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score (n=102, 105, 106) | A 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. Change: score at observation minus score at baseline. Mean change from baseline was adjusted for the baseline total score, age group and gender. | ITT Population n is the number of participants with evaluable data. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline and Week 8 |
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| Secondary | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | A 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 equals (=) more affected. | ITT Population n is the number of participants with non-missing values | Posted | Number | Percentage of Participants | Weeks 1, 2, 3, 4, 6, and 8 |
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| Secondary | Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved' | A 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) or 2 (much improved) on the scale. Higher score = more affected. | ITT Population n is the number of participants with non-missing values | Posted | Number | Percentage of Participants | Weeks 1, 2, 3, 4, 6, and 8 |
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Adverse events (AEs) were recorded from informed consent and assent through the first follow up visit (Week 11) for non-serious AEs; the second follow up visit (Week 13) for serious AEs (SAEs); or at Week 8 for participants entering the extension study.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
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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 | Matched placebo tablets administered once daily for 8 weeks (treatment phase), followed by placebo tablets administered once daily for 1 week (taper phase) only for those participants not entering the extension study. | 2 | 120 | 34 | 120 | ||
| EG001 | DVS SR Low Dose | DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 20, 25 or 35 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study. | 2 | 122 | 46 | 122 | ||
| EG002 | DVS SR High Dose | DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study. | 1 | 121 | 53 | 121 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abscess | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Aggression | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
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| Suicide attempt | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
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| Dermatomyositis | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Male |
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Adjusted mean difference = Placebo - DVS SR High Dose
| Mixed-effects model for repeated measure |
Hochberg procedure was used to control for multiplicity |
| 0.333 |
| Mean Difference (Net) |
| 1.52 |
| 2-Sided |
| 95 |
| -1.56 |
| 4.61 |
| Superiority or Other |
| DVS SR High Dose |
DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study. |
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DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
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DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
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