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Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) in the Treatment of Major Depressive Disorder

Primary Purpose

Major Depressive Disorder

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Desvenlafaxine Succinate Sustained-Release (DVS SR)

placebo

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major Depressive Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adult, outpatient with primary diagnosis of Major Depressive Disorder (depressive symptoms for at least 30 days prior to screening)
Hamilton Psychiatric Rating Scale for Depression (HAM-D 17) total score of >= 20
Clinical Global Impressions Scale-Severity (CGI-S) score of >= 4

Exclusion Criteria:

Clinical instability - 25% or greater increase/decrease in HAM-D 17 total score from screening to baseline
Significant risk of suicide as assessed by clinician judgement, HAM-D 17 and Columbia Suicide-Severity Rating Scale scores Other eligibility criteria also apply

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Desvenlafaxine succinate sustained-release 25 mg

Desvenlafaxine succinate sustained-release 50 mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in HAM-D17 Total Score at the Final On-therapy (FOT)Evaluation (Week 8 or ET)

HAM-D17: 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.

Secondary Outcome Measures

Number of Participants With Categorical Scores on CGI-Improvement (CGI-I) at FOT Evaluation (Week 8 or ET)

CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is 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 Mean CGI-S Score at FOT Evaluation (Week 8 or ET)

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 From Baseline in MADRS Total Score at FOT Evaluation (Week 8 or ET)

MADRS 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 From Baseline in HAM-D6 Total Score at FOT Evaluation (Week 8 or ET)

HAM-D6: a standardized, clinician-administered rating scale that assesses 6 items characteristically associated with major depression and is a subset of HAM-D17. HAM-D6 score ranges from 0-22. The scale uses HAM-D17 items: 1, 2, 7, 8, 10 and 13. Item 13 is scored 0-2 and all others are scored 0-4.

Number of Participants With a Response on the HAM-D17 at FOT Evaluation (Week 8 or ET)

A HAM-D17 responder was defined as a participant with a 50% or greater decrease from baseline in HAM-D17 score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual 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.

Number of Participants in Remission Based on the HAM-D17 at FOT Evaluation (Week 8 or ET)

Remission was defined as a HAM-D17 score of less than or equal to 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual 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.

Number of Participants With a Response on the MADRS Score at FOT Evaluation (Week 8 or ET)

A MADRS responder was defined as a participant with a 50% or greater decrease from baseline in MADRS score. It 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).

Number of Participants With a Response on the CGI-I Score at FOT Evaluation (Week 8 or ET)

CGI-I responder was defined as a participant with a score of 1 (very much improved) or 2 (much improved) on the CGI-I. CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.

Full Information

NCT ID

NCT00798707

First Posted

November 25, 2008

Last Updated

June 8, 2011

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00798707

Brief Title

Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) in the Treatment of Major Depressive Disorder

Official Title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of 2 Fixed Doses (25 and 50 mg/Day) of DVS SR Tablets in Adult Outpatients With Major Depressive Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

June 2011

Overall Recruitment Status

Completed

Study Start Date

December 2008 (undefined)

Primary Completion Date

April 2010 (Actual)

Study Completion Date

April 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The primary purpose of this study is to compare the antidepressant efficacy and safety of two doses of DVS SR (25 and 50 mg/day) in the treatment of adults with Major Depressive Disorder. The study will also assess changes in sexual function and general and functional quality of life outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

Keywords

Major Depressive Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

709 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Desvenlafaxine succinate sustained-release 25 mg

Arm Type

Experimental

Arm Title

Desvenlafaxine succinate sustained-release 50 mg

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Desvenlafaxine Succinate Sustained-Release (DVS SR)

Intervention Description

25 mg tablet, once daily dosing for 8 weeks

Intervention Type

Drug

Intervention Name(s)

Desvenlafaxine Succinate Sustained-Release (DVS SR)

Intervention Description

50 mg tablet, once daily dosing for 8 weeks

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

Matching placebo tablets (25 or 50 mg). Daily dosing for 10 +/- 4 days during a placebo lead-in period, and then 8 weeks during the double-blind period.

Primary Outcome Measure Information:

Title

Change From Baseline in HAM-D17 Total Score at the Final On-therapy (FOT)Evaluation (Week 8 or ET)

Description

Time Frame

Baseline and Week 8 (or ET)

Secondary Outcome Measure Information:

Title

Number of Participants With Categorical Scores on CGI-Improvement (CGI-I) at FOT Evaluation (Week 8 or ET)

Description

Time Frame

Week 8 (or ET)

Title

Change From Baseline in Mean CGI-S Score at FOT Evaluation (Week 8 or ET)

Description

Time Frame

Baseline and Week 8 (or ET)

Title

Change From Baseline in MADRS Total Score at FOT Evaluation (Week 8 or ET)

Description

Time Frame

Baseline and Week 8 (or ET)

Title

Change From Baseline in HAM-D6 Total Score at FOT Evaluation (Week 8 or ET)

Description

Time Frame

Baseline and Week 8 (or ET)

Title

Number of Participants With a Response on the HAM-D17 at FOT Evaluation (Week 8 or ET)

Description

Time Frame

Week 8 (or ET)

Title

Number of Participants in Remission Based on the HAM-D17 at FOT Evaluation (Week 8 or ET)

Description

Time Frame

Week 8 (or ET)

Title

Number of Participants With a Response on the MADRS Score at FOT Evaluation (Week 8 or ET)

Description

Time Frame

Week 8 (or ET)

Title

Number of Participants With a Response on the CGI-I Score at FOT Evaluation (Week 8 or ET)

Description

Time Frame

Week 8 (or ET)

Other Pre-specified Outcome Measures:

Title

Population Pharmacokinetics for Desvenlafaxine Plasma Concentrations

Description

Relationship of demographic variables (age, gender, food, race, creatinine, aspartate aminotransaminase, alanine transaminase, bilirubin and concomitant medications) were examined by fitting measured DVS plasma concentrations to a 1 compartment model with first order absorption. Demographic variables were examined for clearance (CL/F), volume of distribution (V/F), Steady Area under Curve (AUC) using nonlinear mixed effects modeling. Final parameter estimates for demographic factors effecting CL/F, V/F and AUC were determined.

Time Frame

Week 2, 4 and 8 (or ET)

Title

Change From Baseline in SDS at FOT Evaluation (Week 8 or ET)

Description

SDS: a self-administered tool that measures functional impairment in 3 domains: Work/School, Social Life, and Family Life/Home Responsibilities. The participant rates the extent to which each of these domains is impaired by his/her symptoms using a 10 point visual analog scale: (0=not at all impaired, 10=extremely impaired) for a total maximum score of 30.

Time Frame

Baseline and Week 8 (or ET)

Title

Change From Baseline in WHO-5 Total Score at FOT Evaluation (Week 8 or ET)

Description

WHO-5 evaluates positive psychological well-being. WHO-5 consists of 5 questions and each is rated on a 6-point scale. The total score ranges from 0 to 25 (0= worst possible quality of life; 25=best possible quality of life).

Time Frame

Baseline and Week 8 (or ET)

Title

Percentage of Participants With Sexual Dysfunction at FOT Evaluation (Week 8 or ET)

Description

ASEX scale includes 5 questions that evaluate sexual function exclusively during the week prior to completion in the following areas: libido, excitability and ability to reach orgasm. Sexual dysfunction=an ASEX total score of 19 or greater, or a score of 5 or greater on any item, or a score of 4 or greater on any 3 items. Participants who have had no sexual activity during the prior week should be instructed to not complete questions 3 through 5.

Time Frame

Week 8 (or ET)

Title

Number of Participants With Categorical Scores on the C-SSRS at FOT Evaluation (Week 8 or ET)

Description

C-SSRS mapped into C-CASA(1-7) to assess whether participant:completed suicide(1),suicide attempt(2)(response of "Yes" on "Actual Attempt"),preparatory acts toward imminent suicidal behavior (3)("Yes" on "Preparatory Acts or Behavior"),suicidal ideation (4)("Yes" on "Wish to be dead","Non-Specific Active Suicidal Thoughts","Active Suicidal Ideation with methods without Intent to Act or Some Intent to Act,without Specific Plan or with Specific Plan and Intent),any suicidal behavior or ideation,self-injurious behaviour(7)("Yes" on "Has subject engaged in Non-suicidal Self-Injurious Behavior").

Time Frame

Week 8 (or ET)

Title

Discontinuation-Emergent Signs and Symptoms (DESS) Total Score

Description

DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of "new symptoms" and "old (but worse) symptoms" (1) and 0 for "old and unchanged symptom," "absent," or "old symptom but improved" for a total possible range of 0 to 43. A higher score indicates more symptoms.

Time Frame

Week 8 to 10 (or ET)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adult, outpatient with primary diagnosis of Major Depressive Disorder (depressive symptoms for at least 30 days prior to screening) Hamilton Psychiatric Rating Scale for Depression (HAM-D 17) total score of >= 20 Clinical Global Impressions Scale-Severity (CGI-S) score of >= 4 Exclusion Criteria: Clinical instability - 25% or greater increase/decrease in HAM-D 17 total score from screening to baseline Significant risk of suicide as assessed by clinician judgement, HAM-D 17 and Columbia Suicide-Severity Rating Scale scores Other eligibility criteria also apply

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Arcadia

State/Province

California

ZIP/Postal Code

91007

Country

United States

Facility Name

Pfizer Investigational Site

City

Beverly Hills

State/Province

California

ZIP/Postal Code

90210

Country

United States

Facility Name

Pfizer Investigational Site

City

Cerritos

State/Province

California

ZIP/Postal Code

90703

Country

United States

Facility Name

Pfizer Investigational Site

City

Garden Grove

State/Province

California

ZIP/Postal Code

92845

Country

United States

Facility Name

Pfizer Investigational Site

City

Los Alamitos

State/Province

California

ZIP/Postal Code

90720

Country

United States

Facility Name

Pfizer Investigational Site

City

St. Petersburg

State/Province

Florida

ZIP/Postal Code

33702

Country

United States

Facility Name

Pfizer Investigational Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30328

Country

United States

Facility Name

Pfizer Investigational Site

City

Smyrna

State/Province

Georgia

ZIP/Postal Code

30080

Country

United States

Facility Name

Pfizer Investigational Site

City

Libertyville

State/Province

Illinois

ZIP/Postal Code

60048

Country

United States

Facility Name

Pfizer Investigational Site

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45408

Country

United States

Facility Name

Pfizer Investigational Site

City

East Providence

State/Province

Rhode Island

ZIP/Postal Code

02914

Country

United States

Facility Name

Pfizer Investigational Site

City

Columbia

State/Province

South Carolina

ZIP/Postal Code

29201

Country

United States

Facility Name

Pfizer Investigational Site

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38117

Country

United States

Facility Name

Pfizer Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

Facility Name

Pfizer Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Pfizer Investigational Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84107

Country

United States

Facility Name

Pfizer Investigational Site

City

Kirkland

State/Province

Washington

ZIP/Postal Code

98033

Country

United States

Facility Name

Pfizer Investigational Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

Facility Name

Pfizer Investigational Site

City

Brown Deer

State/Province

Wisconsin

ZIP/Postal Code

53223

Country

United States

Facility Name

Pfizer Investigational Site

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

4530015

Country

Japan

Facility Name

Pfizer Investigational Site

City

Toyoake

State/Province

Aichi

ZIP/Postal Code

4701192

Country

Japan

Facility Name

Pfizer Investigational Site

City

Noda

State/Province

Chiba

ZIP/Postal Code

2780033

Country

Japan

Facility Name

Pfizer Investigational Site

City

Kitakyusyu

State/Province

Fukuoka

ZIP/Postal Code

8020006

Country

Japan

Facility Name

Pfizer Investigational Site

City

Kitakyusyu

State/Province

Fukuoka

ZIP/Postal Code

8078555

Country

Japan

Facility Name

Pfizer Investigational Site

City

Shirakawa

State/Province

Fukushima

ZIP/Postal Code

9610021

Country

Japan

Facility Name

Pfizer Investigational Site

City

Fujioka

State/Province

Gunma

ZIP/Postal Code

3750017

Country

Japan

Facility Name

Pfizer Investigational Site

City

Kumagaya

State/Province

Gunma

ZIP/Postal Code

3600032

Country

Japan

Facility Name

Pfizer Investigational Site

City

Hatsukaichi

State/Province

Hiroshima

ZIP/Postal Code

7380023

Country

Japan

Facility Name

Pfizer Investigational Site

City

Kure

State/Province

Hiroshima

ZIP/Postal Code

7370023

Country

Japan

Facility Name

Pfizer Investigational Site

City

Sapporo

State/Province

Hokkaido

ZIP/Postal Code

0028029

Country

Japan

Facility Name

Pfizer Investigational Site

City

Sapporo

State/Province

Hokkaido

ZIP/Postal Code

0040052

Country

Japan

Facility Name

Pfizer Investigational Site

City

Sapporo

State/Province

Hokkaido

ZIP/Postal Code

0600061

Country

Japan

Facility Name

Pfizer Investigational Site

City

Sapporo

State/Province

Hokkaido

ZIP/Postal Code

600042

Country

Japan

Facility Name

Pfizer Investigational Site

City

Sapporo

State/Province

Hokkaido

ZIP/Postal Code

630061

Country

Japan

Facility Name

Pfizer Investigational Site

City

Sapporo

State/Province

Hokkaido

ZIP/Postal Code

630804

Country

Japan

Facility Name

Pfizer Investigational Site

City

Kobe

State/Province

Hyogo

ZIP/Postal Code

6530841

Country

Japan

Facility Name

Pfizer Investigational Site

City

Kanazawa

State/Province

Ishikawa

ZIP/Postal Code

9208650

Country

Japan

Facility Name

Pfizer Investigational Site

City

Minamiashigara

State/Province

Kanagawa

ZIP/Postal Code

2500136

Country

Japan

Facility Name

Pfizer Investigational Site

City

Yokohama

State/Province

Kanagawa

ZIP/Postal Code

2200004

Country

Japan

Facility Name

Pfizer Investigational Site

City

Yokohama

State/Province

Kanagawa

ZIP/Postal Code

2210835

Country

Japan

Facility Name

Pfizer Investigational Site

City

Yokohama

State/Province

Kanagawa

ZIP/Postal Code

2250012

Country

Japan

Facility Name

Pfizer Investigational Site

City

Yatsushiro

State/Province

Kumamoto

ZIP/Postal Code

8660043

Country

Japan

Facility Name

Pfizer Investigational Site

City

Matsumoto

State/Province

Nagano

ZIP/Postal Code

3908510

Country

Japan

Facility Name

Pfizer Investigational Site

City

Sakai

State/Province

Osaka

ZIP/Postal Code

5900018

Country

Japan

Facility Name

Pfizer Investigational Site

City

Kanzaka

State/Province

Saga

ZIP/Postal Code

8420192

Country

Japan

Facility Name

Pfizer Investigational Site

City

Misato

State/Province

Saitama

ZIP/Postal Code

3410018

Country

Japan

Facility Name

Pfizer Investigational Site

City

Kusatsu

State/Province

Shiga

ZIP/Postal Code

5250037

Country

Japan

Facility Name

Pfizer Investigational Site

City

Bunkyo

State/Province

Tokyo

ZIP/Postal Code

1120012

Country

Japan

Facility Name

Pfizer Investigational Site

City

Chiyoda

State/Province

Tokyo

ZIP/Postal Code

1000006

Country

Japan

Facility Name

Pfizer Investigational Site

City

Chiyoda

State/Province

Tokyo

ZIP/Postal Code

1018643

Country

Japan

Facility Name

Pfizer Investigational Site

City

Itabashi

State/Province

Tokyo

ZIP/Postal Code

1730004

Country

Japan

Facility Name

Pfizer Investigational Site

City

Katsushika

State/Province

Tokyo

ZIP/Postal Code

1250041

Country

Japan

Facility Name

Pfizer Investigational Site

City

Kodaira

State/Province

Tokyo

ZIP/Postal Code

1858551

Country

Japan

Facility Name

Pfizer Investigational Site

City

Minato

State/Province

Tokyo

ZIP/Postal Code

1070052

Country

Japan

Facility Name

Pfizer Investigational Site

City

Nakano

State/Province

Tokyo

ZIP/Postal Code

1640012

Country

Japan

Facility Name

Pfizer Investigational Site

City

Setagaya-ku

State/Province

Tokyo

ZIP/Postal Code

1540004

Country

Japan

Facility Name

Pfizer Investigational Site

City

Setagaya

State/Province

Tokyo

ZIP/Postal Code

1540012

Country

Japan

Facility Name

Pfizer Investigational Site

City

Shibuya

State/Province

Tokyo

ZIP/Postal Code

1500001

Country

Japan

Facility Name

Pfizer Investigational Site

City

Shibuya

State/Province

Tokyo

ZIP/Postal Code

1510053

Country

Japan

Facility Name

Pfizer Investigational Site

City

Shinagawa

State/Province

Tokyo

ZIP/Postal Code

1410021

Country

Japan

Facility Name

Pfizer Investigational Site

City

Shinagawa

State/Province

Tokyo

ZIP/Postal Code

1410022

Country

Japan

Facility Name

Pfizer Investigational Site

City

Shinagawa

State/Province

Tokyo

ZIP/Postal Code

1420021

Country

Japan

Facility Name

Pfizer Investigational Site

City

Shinjyuku

State/Province

Tokyo

ZIP/Postal Code

1600023

Country

Japan

Facility Name

Pfizer Investigational Site

City

Suginami

State/Province

Tokyo

ZIP/Postal Code

1660003

Country

Japan

Facility Name

Pfizer Investigational Site

City

Taito

State/Province

Tokyo

ZIP/Postal Code

1100003

Country

Japan

Facility Name

Pfizer Investigational Site

City

Toshima

State/Province

Tokyo

ZIP/Postal Code

1700002

Country

Japan

Facility Name

Pfizer Investigational Site

City

Meguro

State/Province

Toyko

ZIP/Postal Code

1520012

Country

Japan

Facility Name

Pfizer Investigational Site

City

Ube

State/Province

Yamaguchi

ZIP/Postal Code

7558505

Country

Japan

Facility Name

Pfizer Investigational Site

City

Fukuoka

ZIP/Postal Code

8100001

Country

Japan

Facility Name

Pfizer Investigational Site

City

Fukuoka

ZIP/Postal Code

8100041

Country

Japan

Facility Name

Pfizer Investigational Site

City

Fukushima

ZIP/Postal Code

9600102

Country

Japan

Facility Name

Pfizer Investigational Site

City

Hiroshima

ZIP/Postal Code

7310121

Country

Japan

Facility Name

Pfizer Investigational Site

City

Kumamoto

ZIP/Postal Code

8618002

Country

Japan

Facility Name

Pfizer Investigational Site

City

Kumamoto

ZIP/Postal Code

8620909

Country

Japan

Facility Name

Pfizer Investigational Site

City

Kyoto

ZIP/Postal Code

6168421

Country

Japan

Facility Name

Pfizer Investigational Site

City

Osaka

ZIP/Postal Code

5420006

Country

Japan

Facility Name

Pfizer Investigational Site

City

Saitama

ZIP/Postal Code

33000062

Country

Japan

Facility Name

Pfizer Investigational Site

City

Saitama

ZIP/Postal Code

3390057

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

34183490

Citation

Zilcha-Mano S, Wang X, Wajsbrot DB, Boucher M, Fine SA, Rutherford BR. Trajectories of Function and Symptom Change in Desvenlafaxine Clinical Trials: Toward Personalized Treatment for Depression. J Clin Psychopharmacol. 2021 Sep-Oct 01;41(5):579-584. doi: 10.1097/JCP.0000000000001435.

Results Reference

derived

PubMed Identifier

29140227

Citation

Soares CN, Zhang M, Boucher M. Categorical improvement in functional impairment in depressed patients treated with desvenlafaxine. CNS Spectr. 2019 Jun;24(3):322-332. doi: 10.1017/S1092852917000633. Epub 2017 Nov 15.

Results Reference

derived

PubMed Identifier

26709542

Citation

McIntyre RS, Fayyad R, Mackell JA, Boucher M. Effect of metabolic syndrome and thyroid hormone on efficacy of desvenlafaxine 50 and 100 mg/d in major depressive disorder. Curr Med Res Opin. 2016;32(3):587-99. doi: 10.1185/03007995.2015.1136603. Epub 2016 Jan 13.

Results Reference

derived

PubMed Identifier

26644956

Citation

McIntyre RS, Fayyad RS, Guico-Pabia CJ, Boucher M. A Post Hoc Analysis of the Effect of Weight on Efficacy in Depressed Patients Treated With Desvenlafaxine 50 mg/d and 100 mg/d. Prim Care Companion CNS Disord. 2015 Jun 4;17(3):10.4088/PCC.14m01741. doi: 10.4088/PCC.14m01741. eCollection 2015.

Results Reference

derived

PubMed Identifier

25758058

Citation

Thase ME, Fayyad R, Cheng RF, Guico-Pabia CJ, Sporn J, Boucher M, Tourian KA. Effects of desvenlafaxine on blood pressure in patients treated for major depressive disorder: a pooled analysis. Curr Med Res Opin. 2015 Apr;31(4):809-20. doi: 10.1185/03007995.2015.1020365. Epub 2015 Mar 26.

Results Reference

derived

PubMed Identifier

23334675

Citation

Iwata N, Tourian KA, Hwang E, Mele L, Vialet C. Efficacy and safety of desvenlafaxine 25 and 5050% shaded blockmg/day in a randomized, placebo-controlled study of depressed outpatients. J Psychiatr Pract. 2013 Jan;19(1):5-14. doi: 10.1097/01.pra.0000426323.59698.64.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3151A1-3359&StudyName=Study%20Evaluating%20Desvenlafaxine%20Succinate%20Sustained%20Release%20%28DVS%20SR%29%20in%20the%20Treatment%20of%20Major%20Depressive%20Disorder

Description

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Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) in the Treatment of Major Depressive Disorder

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Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) in the Treatment of Major Depressive Disorder

Major Depressive Disorder

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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