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Clinical Trials/NCT00406640
NCT00406640CompletedPhase 3

A Multicenter, Randomized, 8-Week Double-Blind Acute Phase Followed By a 6-Month Continuation Phase (Open-Label Or Double-Blind) Study to Evaluate the Efficacy, Safety, and Tolerability of DVS SR Versus Escitalopram in Postmenopausal Women With Major Depressive Disorder

Wyeth is now a wholly owned subsidiary of Pfizer0 sites595 target enrollmentStarted: December 2006Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Enrollment
595
Primary Endpoint
Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Baseline to Week 8
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Desvenlafaxine succinate (DVS) is a potent and selective serotonin and norepinephrine reuptake inhibitor (SNRI). This study will investigate the safety, efficacy, and tolerability of DVS SR versus escitalopram in women with major depressive disorder (MDD) who are postmenopausal.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
40 Years to 70 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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 MINI 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.

Arms & Interventions

A

Active Comparator

Intervention: Desvenlafaxine succinate sustained-release (DVS SR) (Drug)

B

Active Comparator

Intervention: Escitalopram (Drug)

Outcomes

Primary Outcomes

Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Baseline to Week 8

Time Frame: Baseline and 8 weeks

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. Change= 8 week adjusted mean HAM-D17 minus baseline adjusted mean HAM-D17.

Secondary Outcomes

  • Percentage of Patients Achieving Response to Treatment at Final On-therapy Evaluation (Acute Phase)(8 weeks)
  • Percentage of Patients Achieving Remission at Final On-therapy Evaluation (Acute Phase)(8 weeks)
  • Change in Hamilton Psychiatric Rating Scale for Anxiety From Baseline to Week 8 (HAM-A) Score(Baseline and Week 8)
  • Change in Dimension Health State EuroQol (EQ-5D) Score From Baseline to Week 8(Baseline and week 8)
  • Discontinuation-Emergent Signs and Symptoms (DESS) Total Score(6 months)
  • Change in Clinical Global Impression Severity (CGI-S) Score From Baseline to Week(Baseline and 8 weeks)
  • Percentage of Responders Maintaining Response to Treatment at Final On-therapy Evaluation (Double Blind Continuation Phase)(6 months)
  • Percentage of Responders Improving Response to Remission During 6-month Double Blind Continuation Phase(6 months)
  • Clinical Global Impression Improvement (CGI-I) Score at 8 Weeks(8 weeks)
  • Percentage of Non-Responders Achieving Response at Final Evaluation of 6-month Open-Label (OL)Extension Phase(6 months)
  • Percentage of Responders Achieving Remission at Final On-therapy Evaluation (Double Blind Continuation Phase)(6 months)
  • Percentage of Non-Responders Achieving Remission at Final Evaluation of 6-month Open-Label Extension Phase(6 months)

Investigators

Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor Class
Industry

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