Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) In The Treatment Of Peri- And Postmenopausal Women With Major Depressive Disorder (DVS 3364)
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01121484
First received: May 3, 2010
Last updated: March 30, 2012
Last verified: January 2012
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Purpose
A multicenter, 10-week study to evaluate the efficacy and safety of 50 mg of desvenlafaxine succinate sustained-release formulation (DVS SR) versus placebo in the treatment of peri- and postmenopausal women with major depressive disorder
| Condition | Intervention | Phase |
|---|---|---|
|
Major Depressive Disorder |
Drug: desvenlafaxine succinate sustained-release Drug: placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Multicenter, Parallel-Group, Randomized, 10-Week, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of 50 mg Of DVS SR In The Treatment Of Peri- And Postmenopausal Women With Major Depressive Disorder |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Change From Baseline in Hamilton Depression Scale (HAM-D17) at Week 8 [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]HAM-D17, clinician-rated interview, measures presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, & weight loss). Total score ranges from 0 to 52; higher scores indicate more severe depression. Change from baseline: score at observation minus score at baseline.
Secondary Outcome Measures:
- Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]CGI-I: 7-point scale in which the clinician rated how much the participant's condition has changed compared to baseline. Scores ranged from 1 (very much improved) to 7 (very much worse). Improvement defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
- Change From Baseline in Clinical Global Impression - Severity (CGI-S) at Week 8 [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline.
- Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score at Week 8 [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Change: score at observation minus score at baseline.
- Change From Baseline in Quick Inventory of Depressive Symptoms, 16 Question Self-report (QIDS-SR) [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]This is a 16-item self reported questionnaire that measures depressive symptoms. Improvement reported as change in depressive score. Score ranges from 0 to 42, with higher numbers indicating more severe symptom reporting. Change: score at observation minus score at baseline.
- Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Week 8 [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]10 centimeter (cm) line (Visual Analog Scale) marked by participant. Intensity of pain range (over past week): 0 = no pain to 10 = worst possible pain. Change: score at observation minus score at baseline.
| Enrollment: | 439 |
| Study Start Date: | June 2010 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: desvenlafaxine succinate sustained-release |
Drug: desvenlafaxine succinate sustained-release
50-mg DVS SR tablets taken orally once daily.
Other Name: Pristiq
|
| Placebo Comparator: Placebo |
Drug: placebo
Placebo tablets taken orally once daily.
|
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 aged 40 to 70 years who are fluent in both written and spoken English.
Postmenopausal status defined by 12 consecutive months of spontaneous amenorrhea; less than 12 consecutive months with at least 6 consecutive months of spontaneous amenorrhea and a pre-baseline follicle-stimulating hormone (FSH) level >40 mIU/mL; or 6 months postsurgical bilateral oophorectomy (with or without hysterectomy). Perimenopausal women defined by the presence of any of the following within 6 months before baseline:
- an absolute change of 7 days or more in menstrual cycle length within 6 months before baseline;
- a change in menstrual flow amount (2 or more flow categories, eg, from light or moderately light to moderately heavy or heavy);
- a change in duration (absolute change of 2 or more days); or
- periods of amenorrhea lasting at least 3 months.
- A primary diagnosis of major depressive disorder (MDD) based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR), single or recurrent episode, without psychotic features using the modified Mini International Neuropsychiatric Interview (MINI).
- A Montgomery and Asberg Depression Rating Scale (MADRS) total score >=25 at the screening and baseline (day -1) visits and no more than a 5-point improvement from screening to baseline.
Exclusion Criteria:
- Treatment with DVS SR (Pristiq®) at any time in the past and/or venlafaxine, ie, Effexor® or Effexor XR®, 1 year prior to baseline.
- Treatment-resistant; eg, in the past 3 years if any of the following treatments have failed: (a) 3 or more previous adequate trials of >=2 classes of antidepressant medication, (b) electroconvulsive therapy, or (c) 2 adequate trials of psychotherapy (eg, behavior therapy, behavior-marital therapy).
- History or current evidence of gastrointestinal disease known to interfere with the absorption or excretion of drugs or a history of surgery known to interfere with the absorption or excretion of drugs.
- Known presence of raised intraocular pressure or history of narrow-angle glaucoma.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01121484
Show 44 Study Locations
Show 44 Study LocationsSponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01121484 History of Changes |
| Other Study ID Numbers: | 3151A1-3364, B2061029 |
| Study First Received: | May 3, 2010 |
| Results First Received: | February 16, 2012 |
| Last Updated: | March 30, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Depressive Disorder Depression Depressive Disorder, Major Mood Disorders Mental Disorders Behavioral Symptoms 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 16, 2013