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Trial record 50 of 89 for:    DESVENLAFAXINE

A 6-Month Extension Study To The B2061032 Study To Evaluate The Safety, Tolerability, And Efficacy Of DVS SR In The Treatment Of Child And Adolescent Outpatients With MDD

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ClinicalTrials.gov Identifier: NCT01371708
Recruitment Status : Completed
First Posted : June 13, 2011
Results First Posted : December 8, 2016
Last Update Posted : July 27, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Intervention Drug: DVS SR
Enrollment 283
Recruitment Details  
Pre-assignment Details A total of 304 participants completed study B2061032, 283 of whom were enrolled in the current extension study, B2061030, and 281 received treatment.
Arm/Group Title Placebo/DVS-SR DVS-SR, Low Dose/DVS-SR DVS-SR, High Dose/DVS-SR
Hide Arm/Group Description 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. 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. 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.
Period Title: Overall Study
Started 92 93 98
Received Treatment 91 93 97
Completed 66 63 59
Not Completed 26 30 39
Reason Not Completed
Insufficient clinical response             3             2             0
Lost to Follow-up             5             9             7
Protocol Violation             2             1             2
No longer willing to participate             7             7             13
Medication error/not related to AE             0             1             0
Not specified             3             2             4
Adverse Event             5             8             12
Started but did not receive treatment             1             0             1
Arm/Group Title Placebo/DVS-SR DVS-SR, Low Dose/DVS-SR DVS-SR, High Dose/DVS-SR Total
Hide Arm/Group Description 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. 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 91 93 97 281
Hide Baseline Analysis Population Description
All participants who received at least 1 dose of study drug
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 91 participants 93 participants 97 participants 281 participants
7 to 11 years 28 26 33 87
12 to 17 years 63 67 64 194
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants 93 participants 97 participants 281 participants
Female
43
  47.3%
52
  55.9%
60
  61.9%
155
  55.2%
Male
48
  52.7%
41
  44.1%
37
  38.1%
126
  44.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 91 participants 93 participants 97 participants 281 participants
Asian 1 1 0 2
Black or African American 20 23 28 71
White 62 65 60 187
Other 8 4 9 21
1.Primary Outcome
Title Percentage of Participants With a Treatment-emergent Adverse Event (TEAE)
Hide Description A TEAE was defined as an event that was absent before treatment and emerged or worsened during the treatment period.
Time Frame From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug in study B2061030
Arm/Group Title Placebo/DVS-SR DVS-SR, Low Dose/DVS-SR DVS-SR, High Dose/DVS-SR
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 91 93 97
Measure Type: Number
Unit of Measure: Percentage of participants
78.0 73.1 71.1
2.Primary Outcome
Title Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) (Combination Group)
Hide Description A TEAE was defined as an event that was absent before treatment and emerged or worsened during the treatment period.
Time Frame From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug in study B2061030
Arm/Group Title Combination Group
Hide Arm/Group Description:
Combination of 3 groups of participants from previous study B2061032 received desvenlafaxine succinate sustained release in flexible dosing ranging from 20 to 50 mg in the current extension study, B2061030.
Overall Number of Participants Analyzed 281
Measure Type: Number
Unit of Measure: Percentage of participants
74.0
3.Secondary Outcome
Title Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases
Hide Description 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.
Time Frame From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo/DVS-SR DVS-SR, Low Dose/DVS-SR DVS-SR, High Dose/DVS-SR
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 63 57 56
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-6.79  (12.05) -10.72  (10.80) -8.57  (13.01)
4.Secondary Outcome
Title 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)
Hide Description 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.
Time Frame From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Combination Group
Hide Arm/Group Description:
Combination of 3 groups of participants from previous study B2061032 received desvenlafaxine succinate sustained release in flexible dosing ranging from 20 to 50 mg in the current extension study, B2061030.
Overall Number of Participants Analyzed 176
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-8.63  (12.03)
5.Secondary Outcome
Title Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases
Hide Description 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.
Time Frame From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo/DVS-SR DVS-SR, Low Dose/DVS-SR DVS-SR, High Dose/DVS-SR
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 63 57 56
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-1.02  (1.18) -1.44  (1.12) -0.70  (1.37)
6.Secondary Outcome
Title Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases (Combination Group)
Hide Description 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.
Time Frame From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Combination Group
Hide Arm/Group Description:
Combination of 3 groups of participants from previous study B2061032 received desvenlafaxine succinate sustained release in flexible dosing ranging from 20 to 50 mg in the current extension study, B2061030.
Overall Number of Participants Analyzed 176
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-1.05  (1.26)
7.Secondary Outcome
Title 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
Hide Description 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.
Time Frame From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo/DVS-SR DVS-SR, Low Dose/DVS-SR DVS-SR, High Dose/DVS-SR
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 63 57 56
Measure Type: Number
Unit of Measure: Percentage of participants
87.3 94.7 89.3
8.Secondary Outcome
Title 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)
Hide Description 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.
Time Frame From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Combination Group
Hide Arm/Group Description:
Combination of 3 groups of participants from previous study B2061032 received desvenlafaxine succinate sustained release in flexible dosing ranging from 20 to 50 mg in the current extension study, B2061030.
Overall Number of Participants Analyzed 176
Measure Type: Number
Unit of Measure: Percentage of participants
90.3
9.Secondary Outcome
Title Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases
Hide Description 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.
Time Frame From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo/DVS-SR DVS-SR, Low Dose/DVS-SR DVS-SR, High Dose/DVS-SR
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 63 57 56
Measure Type: Number
Unit of Measure: Percentage of participants
Week 26: Very much improved 54.0 73.7 53.6
Week 26: Much improved 33.3 21.1 35.7
Week 26: Minimally improved 9.5 5.3 10.7
Week 26: No change 1.6 0.0 0.0
Week 26: Minimally worse 1.6 0.0 0.0
Week 26: Much worse 0.0 0.0 0.0
Week 26: Very much worse 0.0 0.0 0.0
10.Secondary Outcome
Title Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases (Combination Group)
Hide Description 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.
Time Frame From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Combination Group
Hide Arm/Group Description:
Combination of 3 groups of participants from previous study B2061032 received desvenlafaxine succinate sustained release in flexible dosing ranging from 20 to 50 mg in the current extension study, B2061030.
Overall Number of Participants Analyzed 176
Measure Type: Number
Unit of Measure: Percentage of participants
Week 26: Very much improved 60.2
Week 26: Much improved 30.1
Week 26: Minimally improved 8.5
Week 26: No change 0.6
Week 26: Minimally worse 0.6
Week 26: Much worse 0.0
Week 26: Very much worse 0.0
11.Secondary Outcome
Title 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
Hide Description 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.
Time Frame From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo/DVS-SR DVS-SR, Low Dose/DVS-SR DVS-SR, High Dose/DVS-SR
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 63 57 56
Measure Type: Number
Unit of Measure: Percentage of participants
73.0 89.5 75.0
12.Secondary Outcome
Title 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)
Hide Description 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.
Time Frame From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Combination Group
Hide Arm/Group Description:
Combination of 3 groups of participants from previous study B2061032 received desvenlafaxine succinate sustained release in flexible dosing ranging from 20 to 50 mg in the current extension study, B2061030.
Overall Number of Participants Analyzed 176
Measure Type: Number
Unit of Measure: Percentage of participants
79.0
Time Frame 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,
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo/DVS-SR DVS-SR, Low Dose/DVS-SR DVS-SR, High Dose/DVS-SR Combination Group
Hide Arm/Group Description 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. 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. 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. 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.
All-Cause Mortality
Placebo/DVS-SR DVS-SR, Low Dose/DVS-SR DVS-SR, High Dose/DVS-SR Combination Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo/DVS-SR DVS-SR, Low Dose/DVS-SR DVS-SR, High Dose/DVS-SR Combination Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/91 (4.40%)   6/93 (6.45%)   3/97 (3.09%)   13/281 (4.63%) 
Injury, poisoning and procedural complications         
Femur fracture  1  0/91 (0.00%)  0/93 (0.00%)  1/97 (1.03%)  1/281 (0.36%) 
Metabolism and nutrition disorders         
Ketoacidosis  1  0/91 (0.00%)  1/93 (1.08%)  0/97 (0.00%)  1/281 (0.36%) 
Nervous system disorders         
Generalised tonic-clonic seizure  1  0/91 (0.00%)  1/93 (1.08%)  0/97 (0.00%)  1/281 (0.36%) 
Psychiatric disorders         
Aggression  1  1/91 (1.10%)  0/93 (0.00%)  0/97 (0.00%)  1/281 (0.36%) 
Agitation  1  1/91 (1.10%)  1/93 (1.08%)  0/97 (0.00%)  2/281 (0.71%) 
Hallucination, auditory  1  0/91 (0.00%)  1/93 (1.08%)  0/97 (0.00%)  1/281 (0.36%) 
Initial insomnia  1  0/91 (0.00%)  1/93 (1.08%)  0/97 (0.00%)  1/281 (0.36%) 
Major depression  1  1/91 (1.10%)  0/93 (0.00%)  0/97 (0.00%)  1/281 (0.36%) 
Pyromania  1  0/91 (0.00%)  1/93 (1.08%)  0/97 (0.00%)  1/281 (0.36%) 
Suicidal ideation  1  2/91 (2.20%)  1/93 (1.08%)  2/97 (2.06%)  5/281 (1.78%) 
Suicide attempt  1  0/91 (0.00%)  2/93 (2.15%)  1/97 (1.03%)  3/281 (1.07%) 
Suicide threat  1  1/91 (1.10%)  0/93 (0.00%)  0/97 (0.00%)  1/281 (0.36%) 
Respiratory, thoracic and mediastinal disorders         
Bronchial hyperreactivity  1  0/91 (0.00%)  1/93 (1.08%)  0/97 (0.00%)  1/281 (0.36%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA v19
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 DVS-SR, Low Dose/DVS-SR DVS-SR, High Dose/DVS-SR Combination Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   60/91 (65.93%)   57/93 (61.29%)   58/97 (59.79%)   175/281 (62.28%) 
Gastrointestinal disorders         
Abdominal pain upper  1  4/91 (4.40%)  1/93 (1.08%)  8/97 (8.25%)  13/281 (4.63%) 
Constipation  1  0/91 (0.00%)  0/93 (0.00%)  3/97 (3.09%)  3/281 (1.07%) 
Diarrhoea  1  2/91 (2.20%)  1/93 (1.08%)  5/97 (5.15%)  8/281 (2.85%) 
Nausea  1  4/91 (4.40%)  11/93 (11.83%)  6/97 (6.19%)  21/281 (7.47%) 
Vomiting  1  6/91 (6.59%)  2/93 (2.15%)  4/97 (4.12%)  12/281 (4.27%) 
General disorders         
Fatigue  1  3/91 (3.30%)  0/93 (0.00%)  3/97 (3.09%)  6/281 (2.14%) 
Infections and infestations         
Gastroenteritis  1  3/91 (3.30%)  2/93 (2.15%)  1/97 (1.03%)  6/281 (2.14%) 
Gastroenteritis viral  1  7/91 (7.69%)  3/93 (3.23%)  6/97 (6.19%)  16/281 (5.69%) 
Nasopharyngitis  1  9/91 (9.89%)  4/93 (4.30%)  8/97 (8.25%)  21/281 (7.47%) 
Otitis media  1  3/91 (3.30%)  1/93 (1.08%)  1/97 (1.03%)  5/281 (1.78%) 
Pharyngitis streptococcal  1  1/91 (1.10%)  1/93 (1.08%)  3/97 (3.09%)  5/281 (1.78%) 
Sinusitis  1  1/91 (1.10%)  2/93 (2.15%)  5/97 (5.15%)  8/281 (2.85%) 
Upper respiratory tract infection  1  4/91 (4.40%)  10/93 (10.75%)  2/97 (2.06%)  16/281 (5.69%) 
Injury, poisoning and procedural complications         
Accidental overdose  1  8/91 (8.79%)  4/93 (4.30%)  8/97 (8.25%)  20/281 (7.12%) 
Ligament sprain  1  3/91 (3.30%)  0/93 (0.00%)  0/97 (0.00%)  3/281 (1.07%) 
Investigations         
Weight increased  1  5/91 (5.49%)  4/93 (4.30%)  5/97 (5.15%)  14/281 (4.98%) 
Metabolism and nutrition disorders         
Decreased appetite  1  4/91 (4.40%)  2/93 (2.15%)  1/97 (1.03%)  7/281 (2.49%) 
Increased appetite  1  0/91 (0.00%)  3/93 (3.23%)  1/97 (1.03%)  4/281 (1.42%) 
Musculoskeletal and connective tissue disorders         
Back pain  1  3/91 (3.30%)  2/93 (2.15%)  2/97 (2.06%)  7/281 (2.49%) 
Nervous system disorders         
Dizziness  1  4/91 (4.40%)  6/93 (6.45%)  5/97 (5.15%)  15/281 (5.34%) 
Headache  1  12/91 (13.19%)  16/93 (17.20%)  17/97 (17.53%)  45/281 (16.01%) 
Psychomotor hyperactivity  1  3/91 (3.30%)  1/93 (1.08%)  0/97 (0.00%)  4/281 (1.42%) 
Somnolence  1  10/91 (10.99%)  3/93 (3.23%)  1/97 (1.03%)  14/281 (4.98%) 
Psychiatric disorders         
Agitation  1  0/91 (0.00%)  2/93 (2.15%)  3/97 (3.09%)  5/281 (1.78%) 
Attention deficit/hyperactivity disorder  1  3/91 (3.30%)  1/93 (1.08%)  2/97 (2.06%)  6/281 (2.14%) 
Depression  1  1/91 (1.10%)  3/93 (3.23%)  4/97 (4.12%)  8/281 (2.85%) 
Initial insomnia  1  5/91 (5.49%)  0/93 (0.00%)  1/97 (1.03%)  6/281 (2.14%) 
Insomnia  1  7/91 (7.69%)  6/93 (6.45%)  4/97 (4.12%)  17/281 (6.05%) 
Irritability  1  3/91 (3.30%)  4/93 (4.30%)  7/97 (7.22%)  14/281 (4.98%) 
Self injurious behaviour  1  0/91 (0.00%)  3/93 (3.23%)  1/97 (1.03%)  4/281 (1.42%) 
Reproductive system and breast disorders         
Dysmenorrhoea  1  1/91 (1.10%)  0/93 (0.00%)  3/97 (3.09%)  4/281 (1.42%) 
Skin and subcutaneous tissue disorders         
Rash  1  2/91 (2.20%)  3/93 (3.23%)  0/97 (0.00%)  5/281 (1.78%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA v19
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.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01371708     History of Changes
Other Study ID Numbers: B2061030
3151A6-3344 ( Other Identifier: Alias Study Number )
2008-001876-67 ( EudraCT Number )
First Submitted: June 9, 2011
First Posted: June 13, 2011
Results First Submitted: October 14, 2016
Results First Posted: December 8, 2016
Last Update Posted: July 27, 2017