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

NCT00406640 | Completed Phase 3 Results

• 1 other identifier: 3151A1-402
• Study Type: interventional
• Target: 595
• Locations: 6 countries
• Sites: 70

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.

Conditions

Depression; Depressive Disorder; Depressive Disorder, Major

Keywords

MDD; Major Depressive Disorder; Depression

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

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.

A

Escitalopram DRUG

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

B

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (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).
• Montgomery-Asberg Depression Rating Scale (MADRS) total score \> or = 22 at the screening and baseline visit.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Study Sites (70)

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Peoria, Arizona, 85381, United States

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Pasadena, California, 91107, United States

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San Diego, California, 92103, United States

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San Diego, California, 92108, United States

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Denver, Colorado, 80212, United States

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Cromwell, Connecticut, 06416, United States

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Farmington, Connecticut, 06030, United States

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Waterbury, Connecticut, 06708, United States

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Brooksville, Florida, 34613, United States

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Coral Springs, Florida, 33065, United States

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Fort Myers, Florida, 33912, United States

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Gainesville, Florida, 32607, United States

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Maitland, Florida, 32751, United States

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Atlanta, Georgia, 30328, United States

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Roswell, Georgia, 30076, United States

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Northfield, Illinois, 60093, United States

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Oak Brook, Illinois, 60523, United States

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Overland Park, Kansas, 66211, United States

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Wichita, Kansas, 67214, United States

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New Orleans, Louisiana, 70115, United States

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Shreveport, Louisiana, 71130, United States

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Baltimore, Maryland, 21208, United States

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Boston, Massachusetts, 02114, United States

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Fall River, Massachusetts, 02721, United States

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Saint Paul, Minnesota, 55101, United States

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Las Vegas, Nevada, 89106, United States

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Piscataway, New Jersey, 08854, United States

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Elmsford, New York, 10523, United States

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Hollis, New York, 11423, United States

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New York, New York, 10032, United States

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New York, New York, 10128, United States

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Syracuse, New York, 13210, United States

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Raleigh, North Carolina, 27612, United States

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Oklahoma City, Oklahoma, 73103, United States

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Philadelphia, Pennsylvania, 19104, United States

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Pittsburgh, Pennsylvania, 15206, United States

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Pittsburgh, Pennsylvania, 15213, United States

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East Providence, Rhode Island, 02914, United States

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Lincoln, Rhode Island, 02865, United States

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Charleston, South Carolina, 29407, United States

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Columbia, South Carolina, 29201, United States

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Mt. Pleasant, South Carolina, 29464, United States

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Memphis, Tennessee, 38117, United States

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Bellaire, Texas, 77401, United States

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Dallas, Texas, 75235, United States

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Denton, Texas, 76201, United States

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Houston, Texas, 77090, United States

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Burlington, Vermont, 05401, United States

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Charlottesville, Virginia, 22903, United States

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Richmond, Virginia, 23230, United States

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Morgantown, West Virginia, 26506, United States

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Middleton, Wisconsin, 53562, United States

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Buenos Aires, 1062, Argentina

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Buenos Aires, 1119, Argentina

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Buenos Aires, 1126, Argentina

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Buenos Aires, 1205, Argentina

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Buenos Aires, 1221, Argentina

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Buenos Aires, 1414, Argentina

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Buenos Aires, 1425, Argentina

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La Plata, 1900, Argentina

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Mendoza, 5500, Argentina

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Santiago, Chile

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Barranquilla, Colombia

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Bogotá, Colombia

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Bucamaranga, Colombia

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Mexico City, Mexico

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Monterrey, Mexico

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Tobasco, Mexico

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Chiclayo, Peru

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Lima, Peru

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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: 21323394 DERIVED

MeSH Terms

Conditions

Depression; Depressive Disorder; Depressive Disorder, Major

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: U. S. Contact Center
• Organization: Wyeth

clintrialresults@wyeth.com

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

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 1, 2006
• Primary Completion: February 1, 2008
• Study Completion: October 1, 2008
• Last Updated: December 28, 2023
• Results First Posted: June 29, 2010

Record last verified: 2023-12

Locations

US (52); CL (1); AR (9); CO (3); ME (3); PE (2)