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

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01371708
• Collaborator: (none)
• Enrollment: 283
• Locations: 36
• Arm: 1
• Actual Duration (Months): 50.6
• Patients Per Site: 7.9
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Drug: DVS SR	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 283 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A 6-month, Open-label, Multi-center, Flexible Dose Extension Study To The B2061032 Study To Evaluate The Safety, Tolerability And Efficacy Of Desvenlafaxine Succinate Sustained Release (Dvs Sr) Tablets In The Treatment Of Children And Adolescent Outpatients With Major Depressive Disorder
• Actual Study Start Date: Feb 2, 2012
• Actual Primary Completion Date: Apr 22, 2016
• Actual Study Completion Date: Apr 22, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Desvenlafaxine Succinate Sustained-Release	Drug: DVS SR; Subjects will receive a flexible-dose of 20, 25, 35, or 50 mg/day as prescribed by the investigator

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) [From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030]

   A TEAE was defined as an event that was absent before treatment and emerged or worsened during the treatment period.

2. Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) (Combination Group) [From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030]

   A TEAE was defined as an event that was absent before treatment and emerged or worsened during the treatment period.

Secondary Outcome Measures

1. Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases [From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030]

   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.

2. 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) [From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030]

   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.

3. Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases [From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030]

   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.

4. Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases (Combination Group) [From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030]

   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.

5. 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 [From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030]

   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.

6. 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) [From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030]

   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.

7. Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases [From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030]

   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.

8. Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases (Combination Group) [From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030]

   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.

9. 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 [From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030]

   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.

10. 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) [From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Completed study B2061032 and who in the investigator's opinion, would benefit from long term treatment with DVS SR

• Willingness and ability to comply with scheduled visits, treatment plan, and procedures

Exclusion Criteria:

• Requires precaution against suicide

• Not in generally healthy medical condition

• Poor compliance with study drug or study procedures during participation in study B2061032

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University Of Alabama At Birmingham, Office Of Psychiatric Research	Birmingham	Alabama	United States	35294-0009
2	Center for Advanced Improvement	Tucson	Arizona	United States	85719
3	Sun Valley Research Center	Imperial	California	United States	92251
4	MCB Clinical Research Centers	Colorado Springs	Colorado	United States	80910
5	Institute of Living/Hartford Hospital	Hartford	Connecticut	United States	06106
6	SJS Clinical Research, Inc.	Destin	Florida	United States	32541
7	Sarkis Clinical Trials	Gainesville	Florida	United States	32607
8	Clinical Neuroscience Solutions	Jacksonville	Florida	United States	32256
9	Medical Research Group of Central Florida	Orange City	Florida	United States	32763
10	Millenia Psychiatry & Research, Inc.	Orlando	Florida	United States	32839
11	Janus Center for Psychiatric Research	West Palm Beach	Florida	United States	33407
12	Northwest Behavioral Research Center	Marietta	Georgia	United States	30060
13	Capstone Clinical Research	Libertyville	Illinois	United States	60048
14	Baber Research Group	Naperville	Illinois	United States	60563
15	Clinco	Terre Haute	Indiana	United States	47802
16	Pharmasite Research, Inc	Baltimore	Maryland	United States	21208
17	Millennium Psychiatric Associates, LLC	Creve Coeur	Missouri	United States	63141
18	Premier Psychiatric Research Institute, LLC	Lincoln	Nebraska	United States	68526
19	Erie County Medical Center/State University of New York (SUNY) at Buffalo Affiliate	Buffalo	New York	United States	14215
20	The Zucker Hillside Hospital, North Shore-Long Island Jewish Health System	Glen Oaks	New York	United States	11004
21	Bioscience Research, LLC.	Mount Kisco	New York	United States	10549
22	Finger Lakes Clinical Research	Rochester	New York	United States	14618
23	Stony Brook University Medical Center, child and Adolescent Psychiatry	Stony Brook	New York	United States	11794-8790
24	Neuro-Behavioral Clinical Research, Inc.	Canton	Ohio	United States	44718
25	Discovery and Wellness Center for Children/University Hospitals Case Medical Center	Cleveland	Ohio	United States	44106
26	Sooner Clinical Research	Oklahoma City	Oklahoma	United States	73112
27	Research Strategies of Memphis, LLC.	Memphis	Tennessee	United States	38119
28	FutureSearch Trials	Austin	Texas	United States	78731
29	Clinical Trials of Texas, Inc.	San Antonio	Texas	United States	78229
30	Clinical Trials of Texas, INC	San Antonio	Texas	United States	78229
31	Allance Research Group	Richmond	Virginia	United States	23230
32	Alliance Research Group	Richmond	Virginia	United States	23230
33	Virginia Commonwealth University	Richmond	Virginia	United States	23298
34	Virginia Treatment Center for Children	Richmond	Virginia	United States	23298
35	Eastside Therapeutic Resource	Kirkland	Washington	United States	98033
36	Biomedica Research Group	Santiago	Region Metropolitana	Chile	7500710

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01371708
• Other Study ID Numbers: B2061030; 3151A6-3344; 2008-001876-67
• First Posted: Jun 13, 2011
• Last Update Posted: Jul 27, 2017
• Last Verified: Jun 1, 2017

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Pfizer: Major Depressive Disorder; MDD; Depression
• Additional relevant MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major

Study Results

Participant Flow

Pre-assignment Detail	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
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

Baseline Characteristics

Arm/Group Title	Placebo/DVS-SR	DVS-SR, Low Dose/DVS-SR	DVS-SR, High Dose/DVS-SR	Total
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 Participants	91	93	97	281
Age, Customized (Number) [Number]
7 to 11 years	28 30.8%	26 28%	33 34%	87 31%
12 to 17 years	63 69.2%	67 72%	64 66%	194 69%
Sex: Female, Male (Count of 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 (Number) [Number]
Asian	1 1.1%	1 1.1%	0 0%	2 0.7%
Black or African American	20 22%	23 24.7%	28 28.9%	71 25.3%
White	62 68.1%	65 69.9%	60 61.9%	187 66.5%
Other	8 8.8%	4 4.3%	9 9.3%	21 7.5%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With a Treatment-emergent Adverse Event (TEAE)
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

Outcome Measure Data

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
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.
Measure Participants	91	93	97
Number [Percentage of participants]	78.0 85.7%	73.1 78.6%	71.1 73.3%

2. Primary Outcome

Title	Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) (Combination Group)
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

Outcome Measure Data

Analysis Population Description

All participants who received at least 1 dose of study drug in study B2061030

Arm/Group Title	Combination Group
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.
Measure Participants	281
Number [Percentage of participants]	74.0 81.3%

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
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

Outcome Measure Data

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
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.
Measure Participants	63	57	56
Mean (Standard Deviation) [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)
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

Outcome Measure Data

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
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.
Measure Participants	176
Mean (Standard Deviation) [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
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

Outcome Measure Data

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
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.
Measure Participants	63	57	56
Mean (Standard Deviation) [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)
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

Outcome Measure Data

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
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.
Measure Participants	176
Mean (Standard Deviation) [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
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

Outcome Measure Data

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
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.
Measure Participants	63	57	56
Number [Percentage of participants]	87.3 95.9%	94.7 101.8%	89.3 92.1%

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)
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

Outcome Measure Data

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
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.
Measure Participants	176
Number [Percentage of participants]	90.3 99.2%

9. Secondary Outcome

Title	Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases
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

Outcome Measure Data

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
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.
Measure Participants	63	57	56
Week 26: Very much improved	54.0 59.3%	73.7 79.2%	53.6 55.3%
Week 26: Much improved	33.3 36.6%	21.1 22.7%	35.7 36.8%
Week 26: Minimally improved	9.5 10.4%	5.3 5.7%	10.7 11%
Week 26: No change	1.6 1.8%	0.0 0%	0.0 0%
Week 26: Minimally worse	1.6 1.8%	0.0 0%	0.0 0%
Week 26: Much worse	0.0 0%	0.0 0%	0.0 0%
Week 26: Very much worse	0.0 0%	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)
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

Outcome Measure Data

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
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.
Measure Participants	176
Week 26: Very much improved	60.2 66.2%
Week 26: Much improved	30.1 33.1%
Week 26: Minimally improved	8.5 9.3%
Week 26: No change	0.6 0.7%
Week 26: Minimally worse	0.6 0.7%
Week 26: Much worse	0.0 0%
Week 26: Very much worse	0.0 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
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

Outcome Measure Data

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
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.
Measure Participants	63	57	56
Number [Percentage of participants]	73.0 80.2%	89.5 96.2%	75.0 77.3%

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)
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

Outcome Measure Data

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
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.
Measure Participants	176
Number [Percentage of participants]	79.0 86.8%

Adverse Events

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,
Arm/Group Title	Placebo/DVS-SR		DVS-SR, Low Dose/DVS-SR		DVS-SR, High Dose/DVS-SR		Combination Group
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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo/DVS-SR		DVS-SR, Low Dose/DVS-SR		DVS-SR, High Dose/DVS-SR		Combination Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/91 (4.4%)		6/93 (6.5%)		3/97 (3.1%)		13/281 (4.6%)
Injury, poisoning and procedural complications
Femur fracture	0/91 (0%)		0/93 (0%)		1/97 (1%)		1/281 (0.4%)
Metabolism and nutrition disorders
Ketoacidosis	0/91 (0%)		1/93 (1.1%)		0/97 (0%)		1/281 (0.4%)
Nervous system disorders
Generalised tonic-clonic seizure	0/91 (0%)		1/93 (1.1%)		0/97 (0%)		1/281 (0.4%)
Psychiatric disorders
Aggression	1/91 (1.1%)		0/93 (0%)		0/97 (0%)		1/281 (0.4%)
Agitation	1/91 (1.1%)		1/93 (1.1%)		0/97 (0%)		2/281 (0.7%)
Hallucination, auditory	0/91 (0%)		1/93 (1.1%)		0/97 (0%)		1/281 (0.4%)
Initial insomnia	0/91 (0%)		1/93 (1.1%)		0/97 (0%)		1/281 (0.4%)
Major depression	1/91 (1.1%)		0/93 (0%)		0/97 (0%)		1/281 (0.4%)
Pyromania	0/91 (0%)		1/93 (1.1%)		0/97 (0%)		1/281 (0.4%)
Suicidal ideation	2/91 (2.2%)		1/93 (1.1%)		2/97 (2.1%)		5/281 (1.8%)
Suicide attempt	0/91 (0%)		2/93 (2.2%)		1/97 (1%)		3/281 (1.1%)
Suicide threat	1/91 (1.1%)		0/93 (0%)		0/97 (0%)		1/281 (0.4%)
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity	0/91 (0%)		1/93 (1.1%)		0/97 (0%)		1/281 (0.4%)
Other (Not Including Serious) Adverse Events
	Placebo/DVS-SR		DVS-SR, Low Dose/DVS-SR		DVS-SR, High Dose/DVS-SR		Combination Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	60/91 (65.9%)		57/93 (61.3%)		58/97 (59.8%)		175/281 (62.3%)
Gastrointestinal disorders
Abdominal pain upper	4/91 (4.4%)		1/93 (1.1%)		8/97 (8.2%)		13/281 (4.6%)
Constipation	0/91 (0%)		0/93 (0%)		3/97 (3.1%)		3/281 (1.1%)
Diarrhoea	2/91 (2.2%)		1/93 (1.1%)		5/97 (5.2%)		8/281 (2.8%)
Nausea	4/91 (4.4%)		11/93 (11.8%)		6/97 (6.2%)		21/281 (7.5%)
Vomiting	6/91 (6.6%)		2/93 (2.2%)		4/97 (4.1%)		12/281 (4.3%)
General disorders
Fatigue	3/91 (3.3%)		0/93 (0%)		3/97 (3.1%)		6/281 (2.1%)
Infections and infestations
Gastroenteritis	3/91 (3.3%)		2/93 (2.2%)		1/97 (1%)		6/281 (2.1%)
Gastroenteritis viral	7/91 (7.7%)		3/93 (3.2%)		6/97 (6.2%)		16/281 (5.7%)
Nasopharyngitis	9/91 (9.9%)		4/93 (4.3%)		8/97 (8.2%)		21/281 (7.5%)
Otitis media	3/91 (3.3%)		1/93 (1.1%)		1/97 (1%)		5/281 (1.8%)
Pharyngitis streptococcal	1/91 (1.1%)		1/93 (1.1%)		3/97 (3.1%)		5/281 (1.8%)
Sinusitis	1/91 (1.1%)		2/93 (2.2%)		5/97 (5.2%)		8/281 (2.8%)
Upper respiratory tract infection	4/91 (4.4%)		10/93 (10.8%)		2/97 (2.1%)		16/281 (5.7%)
Injury, poisoning and procedural complications
Accidental overdose	8/91 (8.8%)		4/93 (4.3%)		8/97 (8.2%)		20/281 (7.1%)
Ligament sprain	3/91 (3.3%)		0/93 (0%)		0/97 (0%)		3/281 (1.1%)
Investigations
Weight increased	5/91 (5.5%)		4/93 (4.3%)		5/97 (5.2%)		14/281 (5%)
Metabolism and nutrition disorders
Decreased appetite	4/91 (4.4%)		2/93 (2.2%)		1/97 (1%)		7/281 (2.5%)
Increased appetite	0/91 (0%)		3/93 (3.2%)		1/97 (1%)		4/281 (1.4%)
Musculoskeletal and connective tissue disorders
Back pain	3/91 (3.3%)		2/93 (2.2%)		2/97 (2.1%)		7/281 (2.5%)
Nervous system disorders
Dizziness	4/91 (4.4%)		6/93 (6.5%)		5/97 (5.2%)		15/281 (5.3%)
Headache	12/91 (13.2%)		16/93 (17.2%)		17/97 (17.5%)		45/281 (16%)
Psychomotor hyperactivity	3/91 (3.3%)		1/93 (1.1%)		0/97 (0%)		4/281 (1.4%)
Somnolence	10/91 (11%)		3/93 (3.2%)		1/97 (1%)		14/281 (5%)
Psychiatric disorders
Agitation	0/91 (0%)		2/93 (2.2%)		3/97 (3.1%)		5/281 (1.8%)
Attention deficit/hyperactivity disorder	3/91 (3.3%)		1/93 (1.1%)		2/97 (2.1%)		6/281 (2.1%)
Depression	1/91 (1.1%)		3/93 (3.2%)		4/97 (4.1%)		8/281 (2.8%)
Initial insomnia	5/91 (5.5%)		0/93 (0%)		1/97 (1%)		6/281 (2.1%)
Insomnia	7/91 (7.7%)		6/93 (6.5%)		4/97 (4.1%)		17/281 (6%)
Irritability	3/91 (3.3%)		4/93 (4.3%)		7/97 (7.2%)		14/281 (5%)
Self injurious behaviour	0/91 (0%)		3/93 (3.2%)		1/97 (1%)		4/281 (1.4%)
Reproductive system and breast disorders
Dysmenorrhoea	1/91 (1.1%)		0/93 (0%)		3/97 (3.1%)		4/281 (1.4%)
Skin and subcutaneous tissue disorders
Rash	2/91 (2.2%)		3/93 (3.2%)		0/97 (0%)		5/281 (1.8%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.