Study Evaluating Long-Term Safety of Desvenlafaxine Succinate Sustained Release With Japanese Adult Subjects in Major Depressive Disorder (MDD)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT00831415

First received: January 27, 2009

Last updated: December 22, 2011

Last verified: December 2011

History of Changes

Results First Received: December 22, 2011

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Major Depressive Disorder
Intervention:	Drug: desvenlafaxine succinate sustained release tablets

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This was a 10-month, open-label, multicenter study of Japanese participants with Major Depressive Disorder (MDD) conducted from March 2009 to March 2011 at 61 sites in Japan.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 304 participants who completed the short-term Core Study (NCT00798707 [3151A1-3359 / B2061003]) consented to enroll in this long-term, open-label, flexible dosing Extension study (NCT00831415 [3151A1-3350 / B2061002]). Baseline in this Extension study = Day 56 of the Core study.

Reporting Groups

	Description
DVS SR	Desvenlafaxine succinate sustained release formulation (DVS SR) flexible dose 25 milligrams per day (mg/day) up to 100 mg/day.

Participant Flow: Overall Study

	DVS SR
STARTED	304
Completers for "Exposure"	227 ^[1]
Study "Completers"	227 ^[2]
COMPLETED	229 ^[3]
NOT COMPLETED	75
Adverse Event	14
Failed to return	3
Physician Decision	6
Lost to Follow-up	9
Protocol Violation	3
Withdrawal by Subject	35
Unsatisfactory response - Efficacy	4
Death	1

[1]	Participants with ≥ 301 days of exposure to study drug and completed study day 308 evaluations.
[2]	Defined as participants whose conclusion of study participation status was “study completed.”
[3]	In addition to Completers for Study includes 2 participants who discontinued after on-therapy period

Baseline Characteristics

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Reporting Groups

	Description
DVS SR	DVS SR flexible dose 25 mg/day up to 100 mg/day.

Baseline Measures

	DVS SR
Number of Participants [units: participants]	304
Age [units: years] Mean ± Standard Deviation	38.45 ± 10.81
Gender [units: participants]
Female	149
Male	155
Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) score ^[1] [units: scores on a scale] Mean ± Standard Deviation	12.86 ± 6.30
Categorical scores on Clinical Global Impression-Improvement [CGI-I] ^[2] [units: participants]
1=Very much improved	75
2=Much improved	81
3=Minimally improved	94
4=No change	51
5=Minimally worse	3
Clinical Global Impression-Severity of Illness [CGI-S] score ^[3] [units: scores on a scale] Mean ± Standard Deviation	3.25 ± 1.11

[1]	HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3-point (0 to 2) or a 5-point scale (0 to 4) with 0=none/absent and 4=most severe, for a maximum total score of 50. Higher scores indicate greater severity.
[2]	CGI-I is 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. Baseline for CGI-I in this Extension study (NCT00831415 [3151A1-3350 / B2061002]) was measured against CGI-I baseline (Day -1) data in Core study (NCT00798707 [3151A1-3359 / B2061003]).
[3]	CGI-S is a 7-point clinician rated scale to assess severity of current illness state. Range is 1 (normal - not ill at all) to 7 (among the most extremely ill). Higher score = more affected.

Outcome Measures

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1. Primary:

Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score [ Time Frame: Baseline (Extension Study) up to Day 308 or Final On-Therapy (FOT) Evaluation ]

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2. Primary:

Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: Baseline (Extension Study) up to Day 329 or 15 days after last dose of study treatment ]

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3. Secondary:

Number of Participants With Categorical Scores on Clinical Global Impression-Improvement (CGI-I) [ Time Frame: Day 308 or FOT Evaluation ]

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4. Secondary:

Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score [ Time Frame: Baseline (Extension Study) up to Day 308 or FOT Evaluation ]

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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
No text entered.

Results Point of Contact:

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

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00831415 History of Changes
Other Study ID Numbers:	3151A1-3350, B2061002
Study First Received:	January 27, 2009
Results First Received:	December 22, 2011
Last Updated:	December 22, 2011
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency United States: Institutional Review Board

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