Phase 4
N=439
Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) In The Treatment Of Peri- And Postmenopausal Women With Major Depressive Disorder (DVS 3364)
Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01121484 ↗Enrolled (actual)
439
Serious AEs
0.9%
Results posted
Mar 2012
Primary outcome: Primary: Change From Baseline in Hamilton Depression Scale (HAM-D17) at Week 8 — 22.8; 22.4; -9.7; -7.4 Units on a scale — p=0.004
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- desvenlafaxine succinate sustained-release (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Female
- Sponsor
- Pfizer
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hamilton Depression Scale (HAM-D17) at Week 8 |
22.8; 22.4; -9.7; -7.4 | 0.004 sig |
| SECONDARY Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) |
51; 39; 67; 37; 53; 62 | <0.001 sig |
| SECONDARY Change From Baseline in Clinical Global Impression - Severity (CGI-S) at Week 8 |
4.4; 4.3; -1.5; -1.1 | 0.002 sig |
| SECONDARY Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score at Week 8 |
31.0; 30.6; -14.8; -11.6 | 0.002 sig |
| SECONDARY Change From Baseline in Quick Inventory of Depressive Symptoms, 16 Question Self-report (QIDS-SR) |
15.1; 14.8; -5.9; -5.2 | 0.158 |
| SECONDARY Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Week 8 |
4.0; 4.0; -1.5; -0.8 | <0.001 sig |
Summary
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
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01121484). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.