Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) Versus Placebo in Peri- and Postmenopausal Women
This study has been completed.
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
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
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
Desvenlafaxine succinate (DVS) is a potent and selective serotonin and norepinephrine reuptake inhibitor (SNRI). The sustained-release (SR) formulation, DVS SR, is being studied in the development program for the treatment of major depressive disorder (MDD), for vasomotor symptoms (VMS) associated with menopause, and for pain associated with peripheral diabetic neuropathy, as well as for the treatment of fibromyalgia syndrome. This study will investigate the safety, efficacy, and tolerability of DVS SR in women with MDD who are peri- and postmenopausal.
| Condition | Intervention | Phase |
|---|---|---|
|
Depression Depressive Disorder Depressive Disorder, Major |
Drug: Desvenlafaxine administered as a succinate salt in a sustained-release form (DVS SR) Drug: Placebo |
Phase 3 |
| 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 |
| Official Title: | A Multicenter, Randomized, 8-week, Double-blind, Placebo-controlled Study Followed by a 6-month Open-label Extension to Evaluate the Efficacy and Safety of DVS SR in Peri- and Postmenopausal Women With Major Depressive Disorder |
Resource links provided by NLM:
Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Primary Outcome Measures:
- Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Baseline to Week 8. [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total score of 50. Change= 8 week adjusted mean HAM-D17 minus baseline adjusted mean HAM-D17
Secondary Outcome Measures:
- Percentage of Patients With Each Clinical Global Impression Improvement (CGI-I) Score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale, the clinician rates how much the patient's illness has improved or worsened relative to the baseline status (1= very much improved; 7= very much worse).
- Percentage of Patients Achieving Remission [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total score of 50.
- Percentage of Patients Achieving Response to Treatment [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]A response is defined as ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total score of 50.
- Change in Hamilton Psychiatric Rating Scale for Anxiety (HAM-A) Score From Baseline to Week 8 [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]The HAM-A is a standardized, clinician-administered rating scale that assesses 14 items characteristically associated with major anxiety disorders. Items are scaled 0 - 4 (0=none and 4=very severe), with a maximum total score of 56. Change= 8 week adjusted mean HAM-A score minus baseline adjusted mean score.
- Change in Dimension Health State EuroQol (EQ-5D) Score From Baseline to Week 8 [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]EQ-5D is a standardized, subject-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health). Change=8 week score minus baseline score.
- 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 ] [ Designated as safety issue: No ]HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total s core of 50. Change= Final Evaluation mean HAM-D17 minus baseline mean HAM-D17.
- Clinical Global Impression Improvement (CGI-I) Score [ Time Frame: 6 months ] [ Designated as safety issue: No ]CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale the clinician rates how much the patient's illness has improved or worsened relative to the baseline status (1= very much improved; 7= very much worse)
- Percentage of Patients Achieving Remission [ Time Frame: 6 months ] [ Designated as safety issue: No ]Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total s core of 50.
- Percentage of Patients Achieving a Response to Treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]A responder is defined as a patient with ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression - 17-item (HAM-D17) score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total score of 50.
- 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 ] [ Designated as safety issue: No ]The HAM-A is a standardized, clinician-administered rating scale that assesses 14 items characteristically associated with major anxiety disorders. Items are scaled 0 - 4 (0=none and 4=very severe), with a maximum total score of 56. Change= Final Evaluation mean HAM-A score minus baseline mean score.
- Change in Dimension Health State EuroQol (EQ-5D) Score From Open Label Baseline to 6 Months [ Time Frame: open label baseline to 6 months ] [ Designated as safety issue: No ]EQ-5D is a standardized, subject-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health). Change=8 week score minus baseline score.
- Discontinuation-Emergent Signs and Symptoms (DESS) Total Score [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of "new symptoms" and "old (but worse) symptoms" (1) and 0 for "old and unchanged symptom," "absent," or "old symptom but improved" for a total possible range of 0 to 43. A higher score indicates more symptoms.
| Enrollment: | 381 |
| Study Start Date: | September 2006 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: Desvenlafaxine administered as a succinate salt in a sustained-release form (DVS SR)
DVS-SR 50-200mg, daily (QD), tablet form, treatment period up to 34 weeks
|
| Placebo Comparator: B |
Drug: Placebo
Placebo, daily (QD), tablet form, treatment period up to 8 weeks
|
Eligibility| Ages Eligible for Study: | 40 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Peri- and postmenopausal women between the ages of 40 and 70 years, inclusive.
- A primary diagnosis of MDD, single or recurrent episode, without psychotic features using the modified International Neuropsychiatric Interview (MINI).
- Montgomery-Asberg Depression Rating Scale (MADRS) total score > or = 22 at the screening and baseline visit.
Exclusion Criteria:
- Use of oral estrogen-, progestin-, androgen-, or Selective Estrogen Receptor Modulator (SERM)-containing drug products 8 weeks before baseline.
- Current (within 12 months) psychoactive substance abuse or dependence (including alcohol), manic episode, post-traumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder.
- A history or active presence of clinically important medical disease.
Additional criteria apply.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00369343
Hide Study Locations
Hide Study LocationsLocations
| United States, Alabama | |
| Birmingham, Alabama, United States, 35226 | |
| United States, Arkansas | |
| Little Rock, Arkansas, United States, 72223 | |
| Springdale, Arkansas, United States, 72762 | |
| United States, California | |
| Palo Alto, California, United States, 94305 | |
| San Diego, California, United States, 92103 | |
| United States, Connecticut | |
| New London, Connecticut, United States, 06320 | |
| United States, Florida | |
| Bradenton, Florida, United States, 34208 | |
| Miami, Florida, United States, 33133 | |
| Tampa, Florida, United States, 33613 | |
| Winter Park, Florida, United States, 32789 | |
| United States, Georgia | |
| Atlanta, Georgia, United States, 30308 | |
| Sandy Springs, Georgia, United States, 30328 | |
| Savannah, Georgia, United States, 31406 | |
| Smyrna, Georgia, United States, 30080 | |
| United States, Idaho | |
| Idaho Falls, Idaho, United States, 83404 | |
| United States, Illinois | |
| Chicago, Illinois, United States, 60634 | |
| United States, Indiana | |
| Indianapolis, Indiana, United States, 46202 | |
| Terre Haute, Indiana, United States, 47802 | |
| United States, Louisiana | |
| Shreveport, Louisiana, United States, 71101 | |
| United States, Maryland | |
| Rockville, Maryland, United States, 20852 | |
| United States, Nebraska | |
| Omaha, Nebraska, United States, 68131 | |
| United States, New Jersey | |
| Cherry Hill, New Jersey, United States, 08002 | |
| United States, New York | |
| Brooklyn, New York, United States, 11235 | |
| United States, North Dakota | |
| Minot, North Dakota, United States, 58701 | |
| United States, Ohio | |
| Beachwood, Ohio, United States, 44122 | |
| Dayton, Ohio, United States, 45408 | |
| Toledo, Ohio, United States, 43623 | |
| United States, Oklahoma | |
| Oklahoma City, Oklahoma, United States, 73118 | |
| Tulsa, Oklahoma, United States, 74135 | |
| United States, Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19131 | |
| United States, South Carolina | |
| Hilton Head Island, South Carolina, United States, 29926 | |
| United States, Texas | |
| Austin, Texas, United States, 78756 | |
| Houston, Texas, United States, 77007 | |
| United States, Virginia | |
| Richmond, Virginia, United States, 23229 | |
| Richmond, Virginia, United States, 23230 | |
| United States, Washington | |
| Seattle, Washington, United States, 98105 | |
| United States, Wisconsin | |
| Brown Deer, Wisconsin, United States, 53223 | |
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
| Study Director: | Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer |
More Information
No publications provided by Wyeth is now a wholly owned subsidiary of Pfizer
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
|
Major Depressive Disorder vasomotor symptoms menopause diabetic neuropathy fibromyalgia |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Depressive Disorder, Major Behavioral Symptoms Mood Disorders Mental Disorders O-desmethylvenlafaxine Neurotransmitter Uptake Inhibitors |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013