Trials Sponsors Conditions Drugs Pricing

Conditions

Depression Depressive Disorder Depressive Disorder, Major

Keywords

MDDMajor Depressive DisorderDepression

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (12)

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
Clinical Global Impression Improvement (CGI-I) Score at 8 Weeks
8 weeks
Change in Clinical Global Impression Severity (CGI-S) Score From Baseline to Week
Baseline and 8 weeks
Change in Hamilton Psychiatric Rating Scale for Anxiety From Baseline to Week 8 (HAM-A) Score
Baseline and Week 8
+7 more secondary outcomes

Study Arms (2)

A

ACTIVE COMPARATOR

Drug: Desvenlafaxine succinate sustained-release (DVS SR)

B

ACTIVE COMPARATOR

Drug: Escitalopram

Interventions

Desvenlafaxine succinate sustained-release (DVS SR)Drug

flexible dose of DVS 50-100 or 200 mg every day during 56 days. Extension until 6 months.

EscitalopramDrug

Flexible dose of Escitalopram 10 or 20 mg every day during 56 days. Extension until 6 months.

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age40 Years - 70 Years

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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).

Sponsors & Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer
Industrylead

Study Sites (70)

Peoria, Arizona, 85381, United States

Pasadena, California, 91107, United States

San Diego, California, 92103, United States

San Diego, California, 92108, United States

Denver, Colorado, 80212, United States

Cromwell, Connecticut, 06416, United States

Farmington, Connecticut, 06030, United States

Related Publications (1)

Soares CN, Thase ME, Clayton A, Guico-Pabia CJ, Focht K, Jiang Q, Kornstein SG, Ninan PT, Kane CP. Open-label treatment with desvenlafaxine in postmenopausal women with major depressive disorder not responding to acute treatment with desvenlafaxine or escitalopram. CNS Drugs. 2011 Mar;25(3):227-38. doi: 10.2165/11586460-000000000-00000.
PMID: 21323394DERIVED

MeSH Terms

Conditions

DepressionDepressive DisorderDepressive Disorder, Major

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofurans

Results Point of Contact

Title: U. S. Contact Center
Organization: Wyeth

Study Officials

Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
STUDY DIRECTOR
Trial Manager
For Argentina: Scheima@wyeth.com
PRINCIPAL INVESTIGATOR
Trial Manager
For Chile: scheima@wyeth.com
PRINCIPAL INVESTIGATOR
Trial Manager
For Mexico: gomezzlj@wyeth.com
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Enrollment

595 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

November 29, 2006

First Posted

December 4, 2006

Study Start

December 2006

Date type not reported

This date has not been verified as actual or estimated.

Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) vs. Escitalopram in Postmenopausal Women

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (12)

Study Arms (2)

A

B

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (70)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (12)

Study Arms (2)

A

B

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (70)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations