Study Evaluating Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR) In The Treatment Of Child and Adolescent Outpatients With Major Depressive Disorder - Study Results

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Depressive Disorder, Major Depressive Disorder
Intervention:	Drug: Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR)

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Eligible participants transitioned from preceding Core study NCT00619619 (3151A6-2000 [B2061012]) on Day 56 to this Extension study NCT00669110 (3151A6-2001 [B2061013]) to continue treatment on a flexible dose schedule. A total of 8 participants (Children n=2 and Adolescent n=6) discontinued during Taper/post-study or Follow-up phase of Core study.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Baseline (Day-1) in the Extension study = Week 8 (Day 56) in the Core study. However, Baseline for the Clinical Global Impressions Scale - Improvement (CGI-I) = Inpatient Day 1 through 4 in the Core study and Baseline for the Columbia Suicide-Severity Rating Scale (C-SSRS) = Day-1 in the Core study.

Reporting Groups

	Description
DVS SR - Children	Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
DVS SR - Adolescents	Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.

Participant Flow: Overall Study

	DVS SR - Children	DVS SR - Adolescents
STARTED	20	20
COMPLETED	12	7
NOT COMPLETED	8	13
Adverse Event	4	3
Caregiver request	3	2
Physician Decision	0	1
Lost to Follow-up	1	0
Protocol Violation	0	5
Withdrawal by Subject	0	2

Baseline Characteristics

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Reporting Groups

	Description
DVS SR - Children	Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
DVS SR - Adolescents	Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.

Baseline Measures

	DVS SR - Children	DVS SR - Adolescents	Total
Number of Participants [units: participants]	20	20	40
Age [units: years] Mean ± Standard Deviation	9.65 ± 1.31	13.55 ± 1.64	11.60 ± 2.46
Gender [units: participants]
Female	11	9	20
Male	9	11	20
Number of participants for Tanner Assessment: Females ^[1] [units: participants]
Breasts Stage 1	4	0	4
Breasts Stage 2	4	1	5
Breasts Stage 3	1	0	1
Breasts Stage 4	0	1	1
Breasts Stage 5	0	7	7
Pubic hair Stage 1	6	0	6
Pubic hair Stage 2	3	2	5
Pubic hair Stage 3	0	0	0
Pubic hair Stage 4	0	2	2
Pubic hair Stage 5	0	5	5
Number of participants for Tanner Assessment: Males ^[2] [units: participants]
Penis Stage 1	5	0	5
Penis Stage 2	3	2	5
Penis Stage 3	1	2	3
Penis Stage 4	0	3	3
Penis Stage 5	0	3	3
Pubic hair Stage 1	6	0	6
Pubic hair Stage 2	2	1	3
Pubic hair Stage 3	1	3	4
Pubic hair Stage 4	0	4	4
Pubic hair Stage 5	0	2	2
Testes Stage 1	5	0	5
Testes Stage 2	2	1	3
Testes Stage 3	2	3	5
Testes Stage 4	0	3	3
Testes Stage 5	0	3	3

[1]	Female pubertal development of secondary sexual characteristics documented by pubic hair development and breast size (test categories). Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). N=9 Children, 9 Adolescent participants at observation. Participants may be represented in more than 1 test category.
[2]	Male pubertal development of secondary sexual characteristics documented by size of genitalia and pubic hair development (test categories). Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity, size). N=9 Children, 10 Adolescent participants at observation. Participants may be represented in > than 1 test category.

Outcome Measures

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1. Primary:

Number of Participants With Adverse Events AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline (Extension study) up to Extension study Week 29 Follow up visit ]

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2. Primary:

Number of Participants for Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories [ Time Frame: Postbaseline (≥Day 1 in Core study NCT00619619) up to Week 26 (Extension study) ]

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3. Other Pre-specified:

Change From Baseline (Bsl) in Children's Depression Rating Scale – Revised (CDRS-R) Total Score at Final On-therapy Visit [ Time Frame: Baseline (Extension study), Extension study Outpatient Weeks 26 and >Week 26 (up to Week 29 or early termination) ]

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4. Other Pre-specified:

Percentage of Participants With Remission (Total Score ≤28) Based on Children's Depression Rating Scale – Revised (CDRS-R) [ Time Frame: Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29) ]

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5. Other Pre-specified:

Change From Baseline (Bsl) in Hamilton Rating Scale for Depression 17-item (HAM-D17) Total Score [ Time Frame: Baseline (Extension study), Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29) ]

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6. Other Pre-specified:

Percentage of Participants With a Categorical Clinical Global Impressions Scales - Severity (CGI-S) Score [ Time Frame: Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29) ]

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7. Other Pre-specified:

Percentage of Participants With a Categorical Clinical Global Impressions Scales - Improvement (CGI-I) Score [ Time Frame: Baseline (Core study NCT00619619), Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29) ]

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8. Other Pre-specified:

Percentage of Participants With a Response of Much Improved or Very Much Improved Based on the Clinical Global Impressions Scales - Improvement (CGI-I) Score [ Time Frame: Baseline (Core study NCT00619619), Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29) ]

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9. Other Pre-specified:

Change From Baseline in Number of Participants for Tanner Assessment at Week 26: Females [ Time Frame: Baseline (Extension study), Week 26 (Extension study) ]

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10. Other Pre-specified:

Change From Baseline in Number of Participants for Tanner Assessment at Week 26: Males [ Time Frame: Baseline (Extension study), Week 26 (Extension study) ]

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11. Other Pre-specified:

Number of Participants With Vital Sign Results of Potential Clinical Importance (PCI): Blood Pressure (BP) [ Time Frame: Baseline (Extension study) up to Week 26 (Extension study) ]

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12. Other Pre-specified:

Number of Participants With Vital Sign Results of Potential Clinical Importance (PCI): Weight [ Time Frame: Baseline (Extension study) up to Week 26 (Extension study) ]

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13. Other Pre-specified:

Number of Participants With Vital Sign Results of Potential Clinical Importance (PCI): Pulse Rate [ Time Frame: Baseline (Extension study) up to Week 26 (Extension study) ]

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14. Other Pre-specified:

Number of Participants With Electrocardiogram (ECG) Results of Potential Clinical Importance (PCI) [ Time Frame: Baseline (Extension study) up to Week 26 (Extension study) ]

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15. Other Pre-specified:

Number of Participants With Electrocardiogram (ECG) Results of Potential Clinical Importance (PCI): Heart Rate (Low) [ Time Frame: Baseline (Extension study) up to Week 26 (Extension study) ]

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16. Other Pre-specified:

Number of Participants With Laboratory Test Results of Potential Clinical Importance (PCI) [ Time Frame: Baseline (Extension study) up to Week 26 (Extension study) ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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 agreement is:

	The only disclosure restriction on the PI is that 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. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier:	NCT00669110 History of Changes
Other Study ID Numbers:	3151A6-2001, B2061013
Study First Received:	April 25, 2008
Results First Received:	April 21, 2011
Last Updated:	April 21, 2011
Health Authority:	United States: Food and Drug Administration