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Relapse Prevention Study Of Desvenlafaxine Succinate Sustained Release In Outpatients With Major Depressive Disorder

Primary Purpose

Major Depressive Disorder

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Desvenlafaxine succinate sustained release 50 mg

Desvenlafaxine succinate sustained release 25 mg

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:

Significant risk of suicide as assessed by clinician judgment, HAM-D17 and Columbia Suicide-Severity Rating Scale scores.
Past treatment with desvenlafaxine succinate sustained release.
Other eligibility criteria also apply.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Desvenlafaxine succinate sustained release 50 mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Time to Relapse Following Randomization to the Double-blind (DB) Phase: Estimated Probability (Percent) of Relapse at DB Day 185

Time to relapse analyzed using log-rank test; defined as Hamilton Psychiatric Scale for Depression-17 item score ≥16 at any time during DB phase, discontinuation for unsatisfactory response or efficacy (need for additional or alternate treatment for depression, investigator decision to remove participant for efficacy reasons, or failure to return if investigator determined related to efficacy), hospitalization for depression, suicide attempt, or suicide. Participants who relapsed after DB day 185 or completed DB therapy without relapse were considered as censored on DB day 185 (study day 325).

Secondary Outcome Measures

Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale

CGI-I is a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.

Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score in the Double-blind Phase

CGI-S is a 7-point clinician rated scale to assess severity of participant's current illness state; range of 1 (normal - not ill at all) to 7 (among the most extremely ill). Higher score = more affected. Change from baseline mean=adjusted mean change calculated using mixed-effects model for repeated measures (MMRM).

Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score in the Double-blind Phase

HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Nine items are scored on a 3 point scale (0=none/absent to 2=most severe) and 8 items are scored on a 5 point scale (0=none/absent to 4=most severe) for a maximum total score of 50; higher score indicates more depression. Change from baseline mean=adjusted mean change calculated using MMRM.

Change From Baseline in Hamilton Psychiatric Scale for Depression-6 Item (HAM-D6) Score in the Double-blind Phase

HAM-D6 is a standardized, clinician-administered rating scale is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 is scored 0 to 2 (0=none/absent to 2=most severe) and all others are scored 0 to 4 (0=none/absent to 4=most severe). Total score ranges from 0 to 22; higher score indicates more depression. Change from baseline mean=adjusted mean change calculated using MMRM.

Number of Participants With Remission Based on Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score at Double-blind Phase Week 26

Change From Baseline of Double-blind Phase in World Health Organization (Five-Item) Well-Being Index

WHO-5 evaluates positive psychological well-being during the past 2 weeks and consists of 5 questions (felt cheerful, in good spirits; felt calm, relaxed; felt active, vigorous; woke up fresh, rested; and daily life filled with things that are interesting) each rated on a 6-point Likert scale from 0 (not present) to 5 (constantly present). Total raw score ranged from 0 (worst possible quality of life) to 25 (best possible quality of life). Change from baseline mean=adjusted mean change calculated using MMRM.

Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Score in the Double-blind Phase

WPAI is a 6 question participant rated questionnaire to determine the degree to which depression affected work productivity while at work and affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher score indicated greater impairment and less productivity.

Full Information

NCT ID

NCT00887224

First Posted

April 22, 2009

Last Updated

November 6, 2014

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00887224

Brief Title

Relapse Prevention Study Of Desvenlafaxine Succinate Sustained Release In Outpatients With Major Depressive Disorder

Official Title

A Multicenter, Double-Blind, Placebo-Controlled, Randomized Withdrawal, Parallel Group Study To Evaluate The Efficacy And Safety Of 50 mg/Day Of DVS SR In Adult Outpatients With Major Depressive Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

May 2012

Overall Recruitment Status

Completed

Study Start Date

June 2009 (undefined)

Primary Completion Date

March 2011 (Actual)

Study Completion Date

March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

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 long-term efficacy and safety of desvenlafaxine succinate sustained release versus placebo in adults with Major Depressive Disorder, using a randomized withdrawal design. Randomized withdrawal means that after receiving desvenlafaxine succinate sustained release for a predetermined period of time, subjects will be selected by chance to either continue receiving the study drug or to be withdrawn from the study drug and receive placebo for the remainder of their participation in the trial. Subjects will not know to which group they have been assigned. The study consists of an up to 14-day screening period followed by an 8-week open-label period in which subjects will knowingly receive 50 mg/day of desvenlafaxine succinate sustained release. Subjects who do not respond to treatment, demonstrating no significant change in their depressive symptoms, will be withdrawn from participation at the end of this period. Responding subjects will receive an additional 3 months of open-label desvenlafaxine succinate sustained release at the same dose. Subjects with stable response to treatment at the conclusion of this 3 month period will be randomized to either desvenlafaxine succinate sustained release at 50 mg/day or placebo in a blinded manner for an additional 6 months or until symptoms of depression return. Following discontinuation at any point after enrollment in the study, subjects will receive two weeks of follow-up monitoring, including one week of blinded taper with 25 mg/day of desvenlafaxine succinate sustained release treatment for any subjects who have been taking desvenlafaxine succinate sustained release prior to discontinuation. Subjects assigned to placebo will receive a blinded placebo taper. Following taper, subjects will be evaluated for one additional week to monitor safety.

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

874 (Actual)

8. Arms, Groups, and Interventions

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 50 mg

Other Intervention Name(s)

Pristiq

Intervention Description

50 mg tablet, once daily. 5 months open-label duration for all enrolled subjects; additional 6 months double-blind duration for randomized subjects assigned to this arm.

Intervention Type

Drug

Intervention Name(s)

Desvenlafaxine succinate sustained release 25 mg

Other Intervention Name(s)

Pristiq

Intervention Description

25 mg tablet for taper, once daily for 1 week

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching placebo tablet, once daily. 6 months double-blind duration for randomized subjects assigned to placebo.

Primary Outcome Measure Information:

Title

Time to Relapse Following Randomization to the Double-blind (DB) Phase: Estimated Probability (Percent) of Relapse at DB Day 185

Description

Time Frame

Double-blind phase Baseline (Study Day 140) up to DB Day 185 (Study Day 325)

Secondary Outcome Measure Information:

Title

Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale

Description

Time Frame

Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322)

Title

Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score in the Double-blind Phase

Description

Time Frame

Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322)

Title

Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score in the Double-blind Phase

Description

Time Frame

Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322)

Title

Change From Baseline in Hamilton Psychiatric Scale for Depression-6 Item (HAM-D6) Score in the Double-blind Phase

Description

Time Frame

Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322)

Title

Number of Participants With Remission Based on Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score at Double-blind Phase Week 26

Description

Time Frame

Double-blind phase Week 26 (Study Day 322)

Title

Change From Baseline of Double-blind Phase in World Health Organization (Five-Item) Well-Being Index

Description

Time Frame

Double-blind phase Baseline (Study Day 140), Week 14 (Study Day 238), Week 26 (Study Day 322)

Title

Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Score in the Double-blind Phase

Description

Time Frame

Double-blind phase Baseline (Study Day 140), Week 14 (Study Day 238), Week 26 (Study Day 322)

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: Significant risk of suicide as assessed by clinician judgment, HAM-D17 and Columbia Suicide-Severity Rating Scale scores. Past treatment with desvenlafaxine succinate sustained release. 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

Beverly Hills

State/Province

California

ZIP/Postal Code

90210

Country

United States

Facility Name

Pfizer Investigational Site

City

Encino

State/Province

California

ZIP/Postal Code

91316

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

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

Pfizer Investigational Site

City

Upland

State/Province

California

ZIP/Postal Code

91786

Country

United States

Facility Name

Pfizer Investigational Site

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Pfizer Investigational Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32256

Country

United States

Facility Name

Pfizer Investigational Site

City

South Miami

State/Province

Florida

ZIP/Postal Code

33143

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

St. Petersburg

State/Province

Florida

ZIP/Postal Code

33716

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

Hoffman Estates

State/Province

Illinois

ZIP/Postal Code

60169

Country

United States

Facility Name

Pfizer Investigational Site

City

Rockville

State/Province

Maryland

ZIP/Postal Code

20852

Country

United States

Facility Name

Pfizer Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10024

Country

United States

Facility Name

Pfizer Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10128

Country

United States

Facility Name

Pfizer Investigational Site

City

Rochester

State/Province

New York

ZIP/Postal Code

14618

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

Portland

State/Province

Oregon

ZIP/Postal Code

97210

Country

United States

Facility Name

Pfizer Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78247

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

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6L 6W6

Country

Canada

Facility Name

Pfizer Investigational Site

City

Medicine Hat

State/Province

Alberta

ZIP/Postal Code

T1B 4E7

Country

Canada

Facility Name

Pfizer Investigational Site

City

Kelowna

State/Province

British Columbia

ZIP/Postal Code

V1Y 1Z9

Country

Canada

Facility Name

Pfizer Investigational Site

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6Z 2L4

Country

Canada

Facility Name

Pfizer Investigational Site

City

Bathurst

State/Province

New Brunswick

ZIP/Postal Code

E2A 4X7

Country

Canada

Facility Name

Pfizer Investigational Site

City

Burlington

State/Province

Ontario

ZIP/Postal Code

L7R 4E2

Country

Canada

Facility Name

Pfizer Investigational Site

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1G 4G3

Country

Canada

Facility Name

Pfizer Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M9W 4L6

Country

Canada

Facility Name

Pfizer Investigational Site

City

Gatineau

State/Province

Quebec

ZIP/Postal Code

J9A 1K7

Country

Canada

Facility Name

Pfizer Investigational Site

City

Pointe-Claire

State/Province

Quebec

ZIP/Postal Code

H9R 4S3

Country

Canada

Facility Name

Pfizer Investigational Site

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1H 4J6

Country

Canada

Facility Name

Pfizer Investigational Site

City

Santiago

ZIP/Postal Code

7530193

Country

Chile

Facility Name

Pfizer Investigational Site

City

Santiago

ZIP/Postal Code

7630000

Country

Chile

Facility Name

Pfizer Investigational Site

City

Santiago

ZIP/Postal Code

8330838

Country

Chile

Facility Name

Pfizer Investigational Site

City

Medellin

State/Province

Antioquia

Country

Colombia

Facility Name

Pfizer Investigational Site

City

Barranquilla

State/Province

Atlantico

Country

Colombia

Facility Name

Pfizer Investigational Site

City

Bogota

State/Province

Cundinamarca

Country

Colombia

Facility Name

Pfizer Investigational Site

City

Bucamaranga

State/Province

Santander

Country

Colombia

Facility Name

Pfizer Investigational Site

City

Rijeka

ZIP/Postal Code

51000

Country

Croatia

Facility Name

Pfizer Investigational Site

City

Zagreb

ZIP/Postal Code

10000

Country

Croatia

Facility Name

Pfizer Investigational Site

City

Tallinn

ZIP/Postal Code

12618

Country

Estonia

Facility Name

Pfizer Investigational Site

City

Tallinn

Country

Estonia

Facility Name

Pfizer Investigational Site

City

Tartu

ZIP/Postal Code

51003

Country

Estonia

Facility Name

Pfizer Investigational Site

City

Voru

ZIP/Postal Code

65608

Country

Estonia

Facility Name

Pfizer Investigational Site

City

Vöru

ZIP/Postal Code

65608

Country

Estonia

Facility Name

Pfizer Investigational Site

City

Espoo

ZIP/Postal Code

02600

Country

Finland

Facility Name

Pfizer Investigational Site

City

Helsinki

ZIP/Postal Code

00100

Country

Finland

Facility Name

Pfizer Investigational Site

City

Joensuu

ZIP/Postal Code

80100

Country

Finland

Facility Name

Pfizer Investigational Site

City

Kuopio

ZIP/Postal Code

70110

Country

Finland

Facility Name

Pfizer Investigational Site

City

Seinajoki

ZIP/Postal Code

60100

Country

Finland

Facility Name

Pfizer Investigational Site

City

Tampere

ZIP/Postal Code

33100

Country

Finland

Facility Name

Pfizer Investigational Site

City

Turku

ZIP/Postal Code

20100

Country

Finland

Facility Name

Pfizer Investigational Site

City

Caen

ZIP/Postal Code

14000

Country

France

Facility Name

Pfizer Investigational Site

City

Dole

ZIP/Postal Code

39100

Country

France

Facility Name

Pfizer Investigational Site

City

Douai

ZIP/Postal Code

59500

Country

France

Facility Name

Pfizer Investigational Site

City

Orvault

ZIP/Postal Code

44700

Country

France

Facility Name

Pfizer Investigational Site

City

Rennes

ZIP/Postal Code

35000

Country

France

Facility Name

Pfizer Investigational Site

City

Liepaja

ZIP/Postal Code

LV-3400

Country

Latvia

Facility Name

Pfizer Investigational Site

City

Sigulda

ZIP/Postal Code

LV-2150

Country

Latvia

Facility Name

Pfizer Investigational Site

City

Sigulda

Country

Latvia

Facility Name

Pfizer Investigational Site

City

Strenci

ZIP/Postal Code

4730

Country

Latvia

Facility Name

Pfizer Investigational Site

City

Kaunas

ZIP/Postal Code

3000

Country

Lithuania

Facility Name

Pfizer Investigational Site

City

Kaunas

ZIP/Postal Code

LT-50185

Country

Lithuania

Facility Name

Pfizer Investigational Site

City

Vilius

Country

Lithuania

Facility Name

Pfizer Investigational Site

City

Vilnius

ZIP/Postal Code

10204

Country

Lithuania

Facility Name

Pfizer Investigational Site

City

Vilnius

ZIP/Postal Code

LT-09112

Country

Lithuania

Facility Name

Pfizer Investigational Site

City

Vilnius

ZIP/Postal Code

LT-10204

Country

Lithuania

Facility Name

Pfizer Investigational Site

City

Skorzewo

State/Province

Poznan

ZIP/Postal Code

60-185

Country

Poland

Facility Name

Pfizer Investigational Site

City

Szczecin

ZIP/Postal Code

71-460

Country

Poland

Facility Name

Pfizer Investigational Site

City

Torun

ZIP/Postal Code

87-100

Country

Poland

Facility Name

Pfizer Investigational Site

City

Tuszyn

ZIP/Postal Code

95-080

Country

Poland

Facility Name

Pfizer Investigational Site

City

Wroclaw

ZIP/Postal Code

50-227

Country

Poland

Facility Name

Pfizer Investigational Site

City

Zuromin

ZIP/Postal Code

09-300

Country

Poland

Facility Name

Pfizer Investigational Site

City

Craiova

State/Province

Dolj

ZIP/Postal Code

200317

Country

Romania

Facility Name

Pfizer Investigational Site

City

Brasov

ZIP/Postal Code

500123

Country

Romania

Facility Name

Pfizer Investigational Site

City

Bucharest

ZIP/Postal Code

041914

Country

Romania

Facility Name

Pfizer Investigational Site

City

Bucuresti

ZIP/Postal Code

010825

Country

Romania

Facility Name

Pfizer Investigational Site

City

Bucuresti

ZIP/Postal Code

041914

Country

Romania

Facility Name

Pfizer Investigational Site

City

Cluj Napoca

ZIP/Postal Code

400012

Country

Romania

Facility Name

Pfizer Investigational Site

City

Bojnice

ZIP/Postal Code

972 01

Country

Slovakia

Facility Name

Pfizer Investigational Site

City

Bratislava

ZIP/Postal Code

820 07

Country

Slovakia

Facility Name

Pfizer Investigational Site

City

Liptovsky Mikulas

ZIP/Postal Code

031 23

Country

Slovakia

Facility Name

Pfizer Investigational Site

City

Michalovce

ZIP/Postal Code

071 01

Country

Slovakia

Facility Name

Pfizer Investigational Site

City

Rimavska Sobota

ZIP/Postal Code

979 12

Country

Slovakia

Facility Name

Pfizer Investigational Site

City

Trencin

ZIP/Postal Code

91101

Country

Slovakia

Facility Name

Pfizer Investigational Site

City

Cape Town

State/Province

Western Cape

ZIP/Postal Code

7530

Country

South Africa

Facility Name

Pfizer Investigational Site

City

Durban

ZIP/Postal Code

3630

Country

South Africa

Facility Name

Pfizer Investigational Site

City

Paarl

ZIP/Postal Code

7646

Country

South Africa

12. IPD Sharing Statement

Citations:

PubMed Identifier

26693033

Citation

Boyer P, Vialet C, Hwang E, Tourian KA. Efficacy of Desvenlafaxine 50 mg/d Versus Placebo in the Long-Term Treatment of Major Depressive Disorder: A Randomized, Double-Blind Trial. Prim Care Companion CNS Disord. 2015 Aug 27;17(4):10.4088/PCC.14m01711. doi: 10.4088/PCC.14m01711. eCollection 2015.

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

26137355

Citation

McIntyre RS, Fayyad RS, Guico-Pabia CJ, Boucher M. An Analysis of Relapse Rates and Predictors of Relapse in 2 Randomized, Placebo-Controlled Trials of Desvenlafaxine for Major Depressive Disorder. Prim Care Companion CNS Disord. 2015 Feb 26;17(1):10.4088/PCC.14m01681. doi: 10.4088/PCC.14m01681. 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

23473348

Citation

Rosenthal JZ, Boyer P, Vialet C, Hwang E, Tourian KA. Efficacy and safety of desvenlafaxine 50 mg/d for prevention of relapse in major depressive disorder:a randomized controlled trial. J Clin Psychiatry. 2013 Feb;74(2):158-66. doi: 10.4088/JCP.12m07974.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3151A1-3360&StudyName=Relapse%20Prevention%20Study%20Of%20Desvenlafaxine%20Succinate%20Sustained%20Release%20In%20Outpatients%20With%20Major%20Depressive%20Disorder

Description

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Relapse Prevention Study Of Desvenlafaxine Succinate Sustained Release In Outpatients With Major Depressive Disorder

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Relapse Prevention Study Of Desvenlafaxine Succinate Sustained Release In Outpatients With Major Depressive Disorder

Major Depressive Disorder

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

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

Learn more about this trial