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| ID | Type | Description | Link |
|---|---|---|---|
| 3151A6-3356 | Other Identifier | Alias Study Number | |
| 2008-002063-13 | EudraCT Number |
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This is a Double-blind Study Evaluating Desvenlafaxine Succinate (DVS SR) Sustained Release vs Placebo in the Treatment of Children and Adolescent Outpatients with Major Depressive Disorder (MDD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DVS SR | Experimental |
| |
| Fluoxetine | Other | Active control for assay sensitivity |
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| Placebo | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| desvenlafaxine succinate sustained release | Drug | Subjects randomized to DVS SR group receive 25, 35 or 50 mg/day based on subject weight at the Baseline visit. DVS SR provided as oral tablets. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score | 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. Adjusted mean presented. | Baseline and Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score | 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. Adjusted mean presented. | Baseline and Week 8 |
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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 |
|---|---|---|---|---|---|---|
| Harmonex Neuroscience Research, Inc. | Dothan | Alabama | 36303 | United States | ||
| Dedicated Clinical Research |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase). |
| FG001 | Fluoxetine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| fluoxetine | Drug | Subjects randomized to the fluoxetine group receive 20 mg/day. Fluoxetine provided as oral capsules |
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| placebo | Drug | Subjects randomized to the placebo group receive corresponding placebo tablets and/capsules |
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| 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 = more affected. | Baseline and 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), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. | Weeks 1, 2, 3, 4, 6, and 8 |
| Goodyear |
| Arizona |
| 85395 |
| United States |
| University of Arizona Clinical and Translational Science Center (CATS) | Tucson | Arizona | 85724 | United States |
| University of Arizona College of Medicine Dept of Psychiatry | Tucson | Arizona | 85724 | United States |
| Arkansas Psychiatric Clinic Clinical Research Trials, P.A. | Little Rock | Arkansas | 72211 | United States |
| ATP Clinical Research, Inc. 1 | Costa Mesa | California | 92626 | United States |
| Behavioral Research Specialists, LLC | Glendale | California | 91206 | United States |
| Synergy Clinical Research Center | National City | California | 91950 | United States |
| Neuropsychiatric Research Center of Orange County | Orange | California | 92868 | United States |
| Pacific Clinical Research Medical Group | Orange | California | 92868 | United States |
| Sharp Mesa Vista Hospital | San Diego | California | 92123 | United States |
| Elite Clinical Trials, Incorporated | Wildomar | California | 92595 | United States |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
| Amedica Research Institute, Incorporated | Hialeah | Florida | 33013 | United States |
| Clinical Neuroscience Solutions, Inc. | Orlando | Florida | 32801 | United States |
| Kolin Research Group | Winter Park | Florida | 32789-3747 | United States |
| Winter Park Memorial Hospital | Winter Park | Florida | 32792 | United States |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | United States |
| Institute for Behavioral Medicine | Smyrna | Georgia | 30080 | United States |
| Psychiatric Associates | Overland Park | Kansas | 66211 | United States |
| Lake Charles Clinical Trials, | Lake Charles | Louisiana | 70629 | United States |
| Neuroscientific Insights | Rockville | Maryland | 20852 | United States |
| Precise Research Centers | Flowood | Mississippi | 39232 | United States |
| Midwest Research Group | Saint Charles | Missouri | 63304 | United States |
| St. Charles Psychiatric Associates - Midwest Research Group | Saint Charles | Missouri | 63304 | United States |
| Heartland Pharma Developments | North Platte | Nebraska | 69101 | United States |
| Creighton University | Omaha | Nebraska | 68131 | United States |
| Center for Psychiatry and Behavioral Medicine, Incorporated | Las Vegas | Nevada | 89128 | United States |
| Cincinnati Children's Hospital Medical Center (New) | Cincinnati | Ohio | 45229 | United States |
| Nina F. Wimpie, MD Pediatrics | Middleburg Heights | Ohio | 44130 | United States |
| North Star Medical Research, LLC | Middleburg Heights | Ohio | 44130 | United States |
| IPS Research Company | Oklahoma City | Oklahoma | 73103 | United States |
| Cutting Edge Research Group | Oklahoma City | Oklahoma | 73116 | United States |
| Paradigm Research Professionals, LLC | Oklahoma City | Oklahoma | 73118 | United States |
| Summit Research Network (Oregon), Incorporated | Portland | Oregon | 97210 | United States |
| Clinical Neuroscience Solutions, Inc | Memphis | Tennessee | 38119 | United States |
| Focus & Balance, LLC | San Antonio | Texas | 78229 | United States |
| Grayline Clinical Drug Trials | Wichita Falls | Texas | 76309 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | United States |
| Summit Research Network (Seattle) LLC | Seattle | Washington | 98104 | United States |
| Rogers Center For Research And Training | Milwaukee | Wisconsin | 53227 | United States |
| Hospital Aranda de la Parra S.A. de C.V. | León | Guanajuato | 37000 | Mexico |
| CIT - Neuropsique, S.C. | Monterrey | Nuevo León | 64610 | Mexico |
Fluoxetine capsules 10 (milligram) mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily as appropriate for 1 week (taper/transition phase).
| FG002 | Desvenlafaxine Succinate Sustained Release (DVS SR) | DVS SR capsules 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) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week. |
| Treated |
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| 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 | Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase). |
| BG001 | Fluoxetine | Fluoxetine capsules 10 mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily for 1 week as appropriate (taper/transition phase). |
| BG002 | DVS SR | DVS SR capsules 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) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week. |
| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score | 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. Adjusted mean presented. | 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. | Posted | 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 | 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. Adjusted mean presented. | ITT Population | Posted | 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 = more affected. | ITT Population | Posted | Number | Percentage of Participants | Baseline and 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), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. | ITT Population | 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 9 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 | Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase). | 0 | 112 | 44 | 112 | ||
| EG001 | Fluoxetine | Fluoxetine capsules 10 mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily for 1 week as appropriate (taper/transition phase). | 2 | 112 | 39 | 112 | ||
| EG002 | DVS SR | DVS SR capsules 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) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week. | 2 | 115 | 47 | 115 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Disinhibition | Psychiatric disorders | MedDRA 17.1 | Non-systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRA 17.1 | Non-systematic Assessment |
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| Suicide attempt | Psychiatric disorders | MedDRA 17.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA 17.1 | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 17.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 17.1 | Non-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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| ID | Term |
|---|---|
| D005473 | Fluoxetine |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Male |
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DVS SR versus Placebo |
| MMRM |
| 0.739 |
| Mean Difference (Final Values) |
| -0.47 |
| 2-Sided |
| 95 |
| -3.23 |
| 2.30 |
Adjusted mean difference = Placebo - DVS SR |
| Superiority or Other |
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