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A 6-Month Open-Label Extension Study to the B2061014 Study to Evaluate the Safety, Tolerability and Efficacy of DVS SR in the Treatment of Children and Adolescents With MDD

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ClinicalTrials.gov Identifier: NCT01371721
Recruitment Status : Completed
First Posted : June 13, 2011
Results First Posted : February 8, 2017
Last Update Posted : February 8, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Masking: None (Open Label);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Intervention Drug: DVS SR
Enrollment 269
Recruitment Details 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).
Pre-assignment Details  
Arm/Group Title Placebo / DVS SR Fluoxetine / DVS SR Desvenlafaxine Succinate Sustained Release / DVS SR
Hide Arm/Group Description Placebo in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031 Fluoxetine 20 mg in previous study B2061014 /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
Period Title: Overall Study
Started 88 89 92
Treated 87 89 92
Completed 59 65 62
Not Completed 29 24 30
Reason Not Completed
Adverse Event             5             4             5
Protocol Violation             6             4             5
Lost to Follow-up             8             2             6
Withdrawal by Subject             5             7             11
Not specified             2             3             0
Lack of Efficacy             2             4             3
Randomized but not treated             1             0             0
Arm/Group Title Placebo / DVS SR Fluoxetine / DVS SR Desvenlafaxine Succinate Sustained Release / DVS SR Total
Hide Arm/Group Description Placebo in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031 Fluoxetine 20 mg in previous study B2061014 /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 Total of all reporting groups
Overall Number of Baseline Participants 87 89 92 268
Hide Baseline Analysis Population Description
Safety population - included all randomized participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 87 participants 89 participants 92 participants 268 participants
12.5  (2.90) 12.4  (3.01) 12.8  (3.14) 12.6  (3.01)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 89 participants 92 participants 268 participants
Female
47
  54.0%
39
  43.8%
49
  53.3%
135
  50.4%
Male
40
  46.0%
50
  56.2%
43
  46.7%
133
  49.6%
1.Primary Outcome
Title Percentage of Participants Experiencing a Treatment Emergent Adverse Event
Hide Description [Not Specified]
Time Frame Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population-includes all treatment-assigned participants who took at least one dose of investigational product in the period of study B2061031.
Arm/Group Title Placebo / DVS SR Fluoxetine / DVS SR Desvenlafaxine Succinate Sustained Release / DVS SR Combination
Hide Arm/Group Description:
Placebo in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
Fluoxetine 20 mg in previous study B2061014 /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
Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
Overall Number of Participants Analyzed 87 89 92 268
Measure Type: Number
Unit of Measure: Percentage of Participants
70.1 75.3 73.9 73.1
2.Secondary Outcome
Title Change From Baseline at Week 26 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score Based on Observed Cases
Hide Description 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.
Time Frame Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo / DVS SR Fluoxetine / DVS SR Desvenlafaxine Succinate Sustained Release / DVS SR Combination
Hide Arm/Group Description:
Placebo in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
Fluoxetine 20 mg in previous study B2061014 /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
Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
Overall Number of Participants Analyzed 55 61 56 172
Mean (Standard Deviation)
Unit of Measure: Score on a Scale
-5.55  (10.80) -6.41  (11.50) -5.32  (7.29) -5.78  (10.03)
3.Secondary Outcome
Title Change From Baseline at Week 26 in the Clinical Global Impression of Severity (CGI-S) Score Based on Observed Cases
Hide Description 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.
Time Frame Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo / DVS SR Fluoxetine / DVS SR Desvenlafaxine Succinate Sustained Release / DVS SR Combination
Hide Arm/Group Description:
Placebo in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
Fluoxetine 20 mg in previous study B2061014 /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
Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
Overall Number of Participants Analyzed 55 61 56 172
Mean (Standard Deviation)
Unit of Measure: Score on a Scale
-0.78  (1.23) -0.77  (1.16) -0.82  (0.92) -0.79  (1.10)
4.Secondary Outcome
Title 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
Hide Description A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Higher score = more affected.
Time Frame Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo / DVS SR Fluoxetine / DVS SR Desvenlafaxine Succinate Sustained Release / DVS SR Combination
Hide Arm/Group Description:
Placebo in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
Fluoxetine 20 mg in previous study B2061014 /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
Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
Overall Number of Participants Analyzed 55 61 56 172
Measure Type: Number
Unit of Measure: Percentage of Participants
90.9 93.4 92.9 92.4
5.Secondary Outcome
Title Percentage of Participants With Remission as Determined by a CDRS-R Score of ≤28 at Week 26 Based on Observed Cases
Hide Description 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.
Time Frame Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo / DVS SR Fluoxetine / DVS SR Desvenlafaxine Succinate Sustained Release / DVS SR Combination
Hide Arm/Group Description:
Placebo in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
Fluoxetine 20 mg in previous study B2061014 /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
Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
Overall Number of Participants Analyzed 55 61 56 172
Measure Type: Number
Unit of Measure: Percentage of Participants
74.5 78.7 73.2 75.6
6.Secondary Outcome
Title Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Week 26 Based on Observed Cases
Hide Description 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.
Time Frame Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo / DVS SR Fluoxetine / DVS SR Desvenlafaxine Succinate Sustained Release / DVS SR Combination
Hide Arm/Group Description:
Placebo in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
Fluoxetine 20 mg in previous study B2061014 /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
Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
Overall Number of Participants Analyzed 55 61 56 172
Measure Type: Number
Unit of Measure: Percentage of Participants
Very Much Improved 63.6 63.9 57.1 61.6
Much Improved 27.3 29.5 35.7 30.8
Minimally Improved 3.6 3.3 5.4 4.1
No Change 3.6 1.6 1.8 2.3
Minimally Worse 0.0 1.6 0.0 0.6
Much Worse 1.8 0.0 0.0 0.6
Very Much Worse 0.0 0.0 0.0 0.0
Time Frame 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.
Adverse Event Reporting Description 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
 
Arm/Group Title Placebo / DVS SR Fluoxetine / DVS SR Desvenlafaxine Succinate Sustained Release / DVS SR Combination
Hide Arm/Group Description Placebo in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031 Fluoxetine 20 mg in previous study B2061014 /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 Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
All-Cause Mortality
Placebo / DVS SR Fluoxetine / DVS SR Desvenlafaxine Succinate Sustained Release / DVS SR Combination
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo / DVS SR Fluoxetine / DVS SR Desvenlafaxine Succinate Sustained Release / DVS SR Combination
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/87 (5.75%)   2/89 (2.25%)   3/92 (3.26%)   10/268 (3.73%) 
Infections and infestations         
Appendicitis * 1  0/87 (0.00%)  0/89 (0.00%)  1/92 (1.09%)  1/268 (0.37%) 
Psychiatric disorders         
Aggression * 1  1/87 (1.15%)  0/89 (0.00%)  0/92 (0.00%)  1/268 (0.37%) 
Frustration * 1  1/87 (1.15%)  0/89 (0.00%)  0/92 (0.00%)  1/268 (0.37%) 
Hallucination, auditory * 1  1/87 (1.15%)  0/89 (0.00%)  0/92 (0.00%)  1/268 (0.37%) 
Irritability * 1  1/87 (1.15%)  0/89 (0.00%)  0/92 (0.00%)  1/268 (0.37%) 
Self injurious behaviour * 1  1/87 (1.15%)  0/89 (0.00%)  0/92 (0.00%)  1/268 (0.37%) 
Suicide attempt * 1  3/87 (3.45%)  1/89 (1.12%)  1/92 (1.09%)  5/268 (1.87%) 
Reproductive system and breast disorders         
Ovarian cyst * 1  0/87 (0.00%)  0/89 (0.00%)  1/92 (1.09%)  1/268 (0.37%) 
Respiratory, thoracic and mediastinal disorders         
Asthma * 1  0/87 (0.00%)  1/89 (1.12%)  0/92 (0.00%)  1/268 (0.37%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v18.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Placebo / DVS SR Fluoxetine / DVS SR Desvenlafaxine Succinate Sustained Release / DVS SR Combination
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   47/87 (54.02%)   61/89 (68.54%)   62/92 (67.39%)   170/268 (63.43%) 
Gastrointestinal disorders         
Abdominal discomfort * 1  3/87 (3.45%)  3/89 (3.37%)  3/92 (3.26%)  9/268 (3.36%) 
Abdominal pain upper * 1  7/87 (8.05%)  8/89 (8.99%)  7/92 (7.61%)  22/268 (8.21%) 
Constipation * 1  2/87 (2.30%)  3/89 (3.37%)  1/92 (1.09%)  6/268 (2.24%) 
Diarrhoea * 1  3/87 (3.45%)  5/89 (5.62%)  2/92 (2.17%)  10/268 (3.73%) 
Dyspepsia * 1  2/87 (2.30%)  0/89 (0.00%)  3/92 (3.26%)  5/268 (1.87%) 
Gastrooesophageal reflux disease * 1  0/87 (0.00%)  1/89 (1.12%)  3/92 (3.26%)  4/268 (1.49%) 
Nausea * 1  9/87 (10.34%)  14/89 (15.73%)  8/92 (8.70%)  31/268 (11.57%) 
Vomiting * 1  5/87 (5.75%)  9/89 (10.11%)  6/92 (6.52%)  20/268 (7.46%) 
General disorders         
Fatigue * 1  2/87 (2.30%)  3/89 (3.37%)  3/92 (3.26%)  8/268 (2.99%) 
Infections and infestations         
Bronchitis * 1  0/87 (0.00%)  1/89 (1.12%)  4/92 (4.35%)  5/268 (1.87%) 
Gastroenteritis * 1  2/87 (2.30%)  3/89 (3.37%)  2/92 (2.17%)  7/268 (2.61%) 
Gastroenteritis viral * 1  4/87 (4.60%)  3/89 (3.37%)  5/92 (5.43%)  12/268 (4.48%) 
Influenza * 1  5/87 (5.75%)  1/89 (1.12%)  1/92 (1.09%)  7/268 (2.61%) 
Nasopharyngitis * 1  11/87 (12.64%)  4/89 (4.49%)  6/92 (6.52%)  21/268 (7.84%) 
Pharyngitis * 1  1/87 (1.15%)  2/89 (2.25%)  4/92 (4.35%)  7/268 (2.61%) 
Pharyngitis streptococcal * 1  2/87 (2.30%)  2/89 (2.25%)  3/92 (3.26%)  7/268 (2.61%) 
Sinusitis * 1  2/87 (2.30%)  3/89 (3.37%)  3/92 (3.26%)  8/268 (2.99%) 
Upper respiratory tract infection * 1  7/87 (8.05%)  9/89 (10.11%)  8/92 (8.70%)  24/268 (8.96%) 
Viral infection * 1  0/87 (0.00%)  3/89 (3.37%)  1/92 (1.09%)  4/268 (1.49%) 
Injury, poisoning and procedural complications         
Accidental overdose * 1  0/87 (0.00%)  2/89 (2.25%)  3/92 (3.26%)  5/268 (1.87%) 
Fall * 1  0/87 (0.00%)  3/89 (3.37%)  2/92 (2.17%)  5/268 (1.87%) 
Ligament sprain * 1  0/87 (0.00%)  2/89 (2.25%)  3/92 (3.26%)  5/268 (1.87%) 
Investigations         
Blood pressure increased * 1  0/87 (0.00%)  3/89 (3.37%)  3/92 (3.26%)  6/268 (2.24%) 
Weight increased * 1  7/87 (8.05%)  11/89 (12.36%)  12/92 (13.04%)  30/268 (11.19%) 
Metabolism and nutrition disorders         
Decreased appetite * 1  3/87 (3.45%)  1/89 (1.12%)  1/92 (1.09%)  5/268 (1.87%) 
Increased appetite * 1  1/87 (1.15%)  2/89 (2.25%)  3/92 (3.26%)  6/268 (2.24%) 
Musculoskeletal and connective tissue disorders         
Back pain * 1  2/87 (2.30%)  2/89 (2.25%)  3/92 (3.26%)  7/268 (2.61%) 
Myalgia * 1  4/87 (4.60%)  0/89 (0.00%)  2/92 (2.17%)  6/268 (2.24%) 
Nervous system disorders         
Dizziness * 1  5/87 (5.75%)  5/89 (5.62%)  8/92 (8.70%)  18/268 (6.72%) 
Headache * 1  12/87 (13.79%)  16/89 (17.98%)  19/92 (20.65%)  47/268 (17.54%) 
Psychiatric disorders         
Insomnia * 1  2/87 (2.30%)  5/89 (5.62%)  0/92 (0.00%)  7/268 (2.61%) 
Irritability * 1  3/87 (3.45%)  3/89 (3.37%)  2/92 (2.17%)  8/268 (2.99%) 
Reproductive system and breast disorders         
Dysmenorrhoea * 1  1/87 (1.15%)  0/89 (0.00%)  5/92 (5.43%)  6/268 (2.24%) 
Respiratory, thoracic and mediastinal disorders         
Cough * 1  6/87 (6.90%)  1/89 (1.12%)  4/92 (4.35%)  11/268 (4.10%) 
Epistaxis * 1  1/87 (1.15%)  3/89 (3.37%)  1/92 (1.09%)  5/268 (1.87%) 
Oropharyngeal pain * 1  6/87 (6.90%)  3/89 (3.37%)  1/92 (1.09%)  10/268 (3.73%) 
Sinus congestion * 1  0/87 (0.00%)  0/89 (0.00%)  3/92 (3.26%)  3/268 (1.12%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v18.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01371721     History of Changes
Other Study ID Numbers: B2061031
3151A6-3357 ( Other Identifier: Alias Study Number )
2008-002064-34 ( EudraCT Number )
First Submitted: June 9, 2011
First Posted: June 13, 2011
Results First Submitted: April 19, 2016
Results First Posted: February 8, 2017
Last Update Posted: February 8, 2017