Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) Versus Placebo in Peri- and Postmenopausal Women

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Wyeth is now a wholly owned subsidiary of Pfizer

ClinicalTrials.gov Identifier:

NCT00369343

First received: August 25, 2006

Last updated: April 9, 2012

Last verified: April 2012

History of Changes

Results First Received: November 26, 2008

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator); Primary Purpose: Treatment
Conditions:	Depression Depressive Disorder Depressive Disorder, Major
Interventions:	Drug: Desvenlafaxine administered as a succinate salt in a sustained-release form (DVS SR) Drug: Placebo

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
Patients were recruited in the United States from September 2006 to September 2007.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were screened over 4 weeks.

Reporting Groups

Description

Desvenlafaxine Succinate Sustained-Release (DVS SR)

Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.

Placebo

Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.

Participant Flow for 2 periods

Period 1: Double-blind Phase

	Desvenlafaxine Succinate Sustained-Release (DVS SR)	Placebo
STARTED	256	125
COMPLETED	212	109
NOT COMPLETED	44	16
Adverse Event	19	4
Failed to return	2	0
Lost to Follow-up	9	2
Protocol Violation	2	0
Withdrawal by Subject	8	6
Lack of Efficacy	0	4
Protocol deviation	4	0

Period 2: Open-label Phase

	Desvenlafaxine Succinate Sustained-Release (DVS SR)	Placebo
STARTED	212	109
COMPLETED	155	79
NOT COMPLETED	57	30
Adverse Event	19	7
Failed to return	4	0
Physician Decision	2	0
Lost to Follow-up	5	3
inadvertently reported study completers	3	2
Protocol Violation	1	3
Withdrawal by Subject	15	6
Lack of Efficacy	4	3
Lack of continuance tolerability	3	4
did not take study drug	1	2

Baseline Characteristics

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Reporting Groups

	Description
Desvenlafaxine Succinate Sustained-Release (DVS SR)	Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
Placebo	Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
Total	Total of all reporting groups

Baseline Measures

	Desvenlafaxine Succinate Sustained-Release (DVS SR)	Placebo	Total
Number of Participants [units: participants]	256	125	381
Age [units: years] Mean ± Standard Deviation	52.01 ± 6.50	52.56 ± 7.17	52.19 ± 6.72
Gender [units: participants]
Female	256	125	381
Male	0	0	0

Outcome Measures

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1. Primary:

Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Baseline to Week 8. [ Time Frame: Baseline to 8 weeks ]

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2. Secondary:

Percentage of Patients With Each Clinical Global Impression Improvement (CGI-I) Score [ Time Frame: 8 weeks ]

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3. Secondary:

Percentage of Patients Achieving Remission [ Time Frame: 8 weeks ]

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4. Secondary:

Percentage of Patients Achieving Response to Treatment [ Time Frame: 8 weeks ]

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5. Secondary:

Change in Hamilton Psychiatric Rating Scale for Anxiety (HAM-A) Score From Baseline to Week 8 [ Time Frame: Baseline to 8 weeks ]

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6. Secondary:

Change in Dimension Health State EuroQol (EQ-5D) Score From Baseline to Week 8 [ Time Frame: Baseline to 8 weeks ]

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7. Secondary:

Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Open Label Baseline to 6 Months [ Time Frame: open label baseline and 6 months ]

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8. Secondary:

Clinical Global Impression Improvement (CGI-I) Score [ Time Frame: 6 months ]

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9. Secondary:

Percentage of Patients Achieving Remission [ Time Frame: 6 months ]

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10. Secondary:

Percentage of Patients Achieving a Response to Treatment [ Time Frame: 6 months ]

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11. Secondary:

Change in Hamilton Psychiatric Rating Scale for Anxiety (HAM-A) Score From Open Label Baseline to 6 Months [ Time Frame: open label baseline to 6 months ]

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12. Secondary:

Change in Dimension Health State EuroQol (EQ-5D) Score From Open Label Baseline to 6 Months [ Time Frame: open label baseline to 6 months ]

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13. Secondary:

Discontinuation-Emergent Signs and Symptoms (DESS) Total Score [ Time Frame: 6 months ]

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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: The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.

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: U. S. Contact Center
Organization: Wyeth
e-mail: clintrialresults@wyeth.com

No publications provided by Wyeth is now a wholly owned subsidiary of Pfizer

Publications automatically indexed to this study:

Kornstein SG, Jiang Q, Reddy S, Musgnung JJ, Guico-Pabia CJ. Short-term efficacy and safety of desvenlafaxine in a randomized, placebo-controlled study of perimenopausal and postmenopausal women with major depressive disorder. J Clin Psychiatry. 2010 Aug;71(8):1088-96.

Responsible Party:	Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:	NCT00369343 History of Changes
Other Study ID Numbers:	3151A1-403
Study First Received:	August 25, 2006
Results First Received:	November 26, 2008
Last Updated:	April 9, 2012
Health Authority:	United States: Food and Drug Administration

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