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| ID | Type | Description | Link |
|---|---|---|---|
| 3151A6-3357 | Other Identifier | Alias Study Number | |
| 2008-002064-34 | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Experiencing a Treatment Emergent Adverse Event | Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline at Week 26 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score Based on Observed Cases | 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. |
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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 |
| 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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Participants who completed the 8-week, double-blind treatment phase of Desvenlafaxine Succinate Sustained Release (DVS SR B2061014 NCT01372150) and completed the 1-week transition phase (week 9) of the short-term study were eligible to participate in this study (DVS SR B2061031).
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo / DVS SR | Placebo in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031 |
| FG001 | Fluoxetine / DVS SR | Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg - 50 mg in extension study B2061031 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study |
| Change From Baseline at Week 26 in the Clinical Global Impression of Severity (CGI-S) Score Based on Observed Cases | 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. | Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study |
| Percentage of Participants With a Clinical Global Impression, Improvement (CGI-I) Response Defined as a Score of 'Very Much Improved' or 'Much Improved' at Week 26 | A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Higher score = more affected. | Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study |
| Percentage of Participants With Remission as Determined by a CDRS-R Score of ≤28 at Week 26 Based on Observed Cases | 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. | Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study |
| Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Week 26 Based on Observed Cases | 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. | Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study |
| 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, Incorporated | 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 |
| 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 |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | United States |
| Institute for Behavioral Medicine, LLC | Smyrna | Georgia | 30080 | United States |
| Psychiatric Associates | Overland Park | Kansas | 66211 | United States |
| Lake Charles Clinical Trials, | Lake Charles | Louisiana | 70629 | United States |
| Precise Research Centers | Flowood | Mississippi | 39232 | United States |
| St. Charles Psychiatric Associates - Midwest Research Group | Saint Charles | Missouri | 63303 | United States |
| Center for Psychiatry and Behavioral Medicine, Incorporated | Las Vegas | Nevada | 89128 | 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 | Witchita 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, Incorporated | 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 | 64010 | Mexico |
| FG002 | Desvenlafaxine Succinate Sustained Release / DVS SR | DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031 |
| 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 / DVS SR | Placebo in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031 |
| BG001 | Fluoxetine / DVS SR | Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg - 50 mg in extension study B2061031 |
| BG002 | Desvenlafaxine Succinate Sustained Release / DVS SR | DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031 |
| 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, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Gender | Count of Participants | 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 | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Change From Baseline at Week 26 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score Based on Observed Cases | 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. | ITT-included all randomized participants who had a baseline (of study B2061031) CDRS-R evaluation (Week 9 of study B2061014) took at least 1 dose of study drug and had at least 1 CDRS-R evaluation after the first dose of study drug in the B2061031 study period. | Posted | Mean | Standard Deviation | Score on a Scale | Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study |
|
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| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline at Week 26 in the Clinical Global Impression of Severity (CGI-S) Score Based on Observed Cases | 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-included all randomized participants who had a baseline (of study B2061031) CDRS-R evaluation (Week 9 of study B2061014) took at least 1 dose of study drug and had at least 1 CDRS-R evaluation after the first dose of study drug in the B2061031 study period. | Posted | Mean | Standard Deviation | Score on a Scale | Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Clinical Global Impression, Improvement (CGI-I) Response Defined as a Score of 'Very Much Improved' or 'Much Improved' at Week 26 | A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Higher score = more affected. | ITT-included all randomized participants who had a baseline (of study B2061031) CDRS-R evaluation (Week 9 of study B2061014) took at least 1 dose of study drug and had at least 1 CDRS-R evaluation after the first dose of study drug in the B2061031 study period. | Posted | Number | Percentage of Participants | Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Remission as Determined by a CDRS-R Score of ≤28 at Week 26 Based on Observed Cases | 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. | ITT-included all randomized participants who had a baseline (of study B2061031) CDRS-R evaluation (Week 9 of study B2061014) took at least 1 dose of study drug and had at least 1 CDRS-R evaluation after the first dose of study drug in the B2061031 study period. | Posted | Number | Percentage of Participants | Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study |
| |||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Experiencing a Treatment Emergent Adverse Event | Safety Population-includes all treatment-assigned participants who took at least one dose of investigational product in the period of study B2061031. | Posted | Number | Percentage of Participants | Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Week 26 Based on Observed Cases | 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-included all randomized participants who had a baseline (of study B2061031) CDRS-R evaluation (Week 9 of study B2061014) took at least 1 dose of study drug and had at least 1 CDRS-R evaluation after the first dose of study drug in the B2061031 study period. | Posted | Number | Percentage of Participants | Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study |
|
Adverse events (AEs) recorded from informed consent and assent through Week 30 and Serious Adverse events (SAEs) collected through Week 32 visit. Participants discontinuing prior to Week 28 visit, AEs collected for 14 days and SAEs for 28 days.
Same event may appear as both an AE and an SAE.Data presented are distinct events.Aneven may be categorized as serious in 1 participant and non-serious in another or 1 participant may have experienced both a serious and non-serious event during study.Safety population included all randomized participants receiving at least 1 dose of study drug
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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 | Placebo in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031 | 5 | 87 | 47 | 87 | ||
| EG001 | Fluoxetine / DVS SR | Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg - 50 mg in extension study B2061031 | 2 | 89 | 61 | 89 | ||
| EG002 | Desvenlafaxine Succinate Sustained Release / DVS SR | DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031 | 3 | 92 | 62 | 92 | ||
| EG003 | Combination | Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg - 50 mg in extension study B2061031 | 10 | 268 | 170 | 268 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Aggression | Psychiatric disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Frustration | Psychiatric disorders | MedDRA v18.1 | Non-systematic Assessment |
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| Hallucination, auditory | Psychiatric disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Self injurious behaviour | Psychiatric disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA v18.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA v18.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v18.1 | Non-systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA v18.1 | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA v18.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Increased appetite | Metabolism and nutrition disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v18.1 | Non-systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v18.1 | Non-systematic Assessment |
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The sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The PI must remove any previously undisclosed Confidential Information (other than the Study results themselves) before public release.
| 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 |
Not provided
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| Male |
|
| OG003 | Combination | Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg - 50 mg in extension study B2061031 |
|
|
| OG003 | Combination | Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg - 50 mg in extension study B2061031 |
|
|
DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031 |
| OG003 | Combination | Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg - 50 mg in extension study B2061031 |
|
|
|
|
| OG003 | Combination | Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg - 50 mg in extension study B2061031 |
|
|