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

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00887224
• Other study ID #: 3151A1-3360
• Secondary ID: B2061004
• Status: Completed
• Phase: Phase 3
• First received: April 22, 2009
• Last updated: November 6, 2014
• Start date: June 2009
• Est. completion date: March 2011

Study information

• Verified date: May 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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predetermined period of time, subjects will be selected by chance to either continue receiving the study drug or to be withdrawn from the study drug and receive placebo for the remainder of their participation in the trial.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 Subjects who do not respond to treatment, demonstrating no significant change in their depressive symptoms, will be withdrawn from participation at the end of this period.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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 874
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Desvenlafaxine succinate sustained release 50 mg
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.
• Desvenlafaxine succinate sustained release 25 mg
25 mg tablet for taper, once daily for 1 week
• Placebo
Matching placebo tablet, once daily. 6 months double-blind duration for randomized subjects assigned to placebo.

Locations

Country	Name	City	State
Canada	Pfizer Investigational Site	Bathurst	New Brunswick
Canada	Pfizer Investigational Site	Burlington	Ontario
Canada	Pfizer Investigational Site	Edmonton	Alberta
Canada	Pfizer Investigational Site	Gatineau	Quebec
Canada	Pfizer Investigational Site	Kelowna	British Columbia
Canada	Pfizer Investigational Site	Medicine Hat	Alberta
Canada	Pfizer Investigational Site	Ottawa	Ontario
Canada	Pfizer Investigational Site	Pointe-Claire	Quebec
Canada	Pfizer Investigational Site	Sherbrooke	Quebec
Canada	Pfizer Investigational Site	Toronto	Ontario
Canada	Pfizer Investigational Site	Vancouver	British Columbia
Chile	Pfizer Investigational Site	Santiago
Chile	Pfizer Investigational Site	Santiago
Chile	Pfizer Investigational Site	Santiago
Colombia	Pfizer Investigational Site	Barranquilla	Atlantico
Colombia	Pfizer Investigational Site	Bogota	Cundinamarca
Colombia	Pfizer Investigational Site	Bucamaranga	Santander
Colombia	Pfizer Investigational Site	Medellin	Antioquia
Croatia	Pfizer Investigational Site	Rijeka
Croatia	Pfizer Investigational Site	Zagreb
Estonia	Pfizer Investigational Site	Tallinn
Estonia	Pfizer Investigational Site	Tallinn
Estonia	Pfizer Investigational Site	Tartu
Estonia	Pfizer Investigational Site	Voru
Estonia	Pfizer Investigational Site	Vöru
Finland	Pfizer Investigational Site	Espoo
Finland	Pfizer Investigational Site	Helsinki
Finland	Pfizer Investigational Site	Joensuu
Finland	Pfizer Investigational Site	Kuopio
Finland	Pfizer Investigational Site	Seinajoki
Finland	Pfizer Investigational Site	Tampere
Finland	Pfizer Investigational Site	Turku
France	Pfizer Investigational Site	Caen
France	Pfizer Investigational Site	Dole
France	Pfizer Investigational Site	Douai
France	Pfizer Investigational Site	Orvault
France	Pfizer Investigational Site	Rennes
Latvia	Pfizer Investigational Site	Liepaja
Latvia	Pfizer Investigational Site	Sigulda
Latvia	Pfizer Investigational Site	Sigulda
Latvia	Pfizer Investigational Site	Strenci
Lithuania	Pfizer Investigational Site	Kaunas
Lithuania	Pfizer Investigational Site	Kaunas
Lithuania	Pfizer Investigational Site	Vilius
Lithuania	Pfizer Investigational Site	Vilnius
Lithuania	Pfizer Investigational Site	Vilnius
Lithuania	Pfizer Investigational Site	Vilnius
Poland	Pfizer Investigational Site	Skorzewo	Poznan
Poland	Pfizer Investigational Site	Szczecin
Poland	Pfizer Investigational Site	Torun
Poland	Pfizer Investigational Site	Tuszyn
Poland	Pfizer Investigational Site	Wroclaw
Poland	Pfizer Investigational Site	Zuromin
Romania	Pfizer Investigational Site	Brasov
Romania	Pfizer Investigational Site	Bucharest
Romania	Pfizer Investigational Site	Bucuresti
Romania	Pfizer Investigational Site	Bucuresti
Romania	Pfizer Investigational Site	Cluj Napoca
Romania	Pfizer Investigational Site	Craiova	Dolj
Slovakia	Pfizer Investigational Site	Bojnice
Slovakia	Pfizer Investigational Site	Bratislava
Slovakia	Pfizer Investigational Site	Liptovsky Mikulas
Slovakia	Pfizer Investigational Site	Michalovce
Slovakia	Pfizer Investigational Site	Rimavska Sobota
Slovakia	Pfizer Investigational Site	Trencin
South Africa	Pfizer Investigational Site	Cape Town	Western Cape
South Africa	Pfizer Investigational Site	Durban
South Africa	Pfizer Investigational Site	Paarl
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Aurora	Colorado
United States	Pfizer Investigational Site	Beverly Hills	California
United States	Pfizer Investigational Site	Dayton	Ohio
United States	Pfizer Investigational Site	Encino	California
United States	Pfizer Investigational Site	Hoffman Estates	Illinois
United States	Pfizer Investigational Site	Jacksonville	Florida
United States	Pfizer Investigational Site	Los Alamitos	California
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	Orange	California
United States	Pfizer Investigational Site	Portland	Oregon
United States	Pfizer Investigational Site	Rochester	New York
United States	Pfizer Investigational Site	Rockville	Maryland
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	Seattle	Washington
United States	Pfizer Investigational Site	Smyrna	Georgia
United States	Pfizer Investigational Site	South Miami	Florida
United States	Pfizer Investigational Site	St. Petersburg	Florida
United States	Pfizer Investigational Site	St. Petersburg	Florida
United States	Pfizer Investigational Site	Upland	California

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada,  Chile,  Colombia,  Croatia,  Estonia,  Finland,  France,  Latvia,  Lithuania,  Poland,  Romania,  Slovakia,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Double-blind phase Baseline (Study Day 140) up to DB Day 185 (Study Day 325)	No
Secondary	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.	Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322)	No
Secondary	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).	Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322)	No
Secondary	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.	Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322)	No
Secondary	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.	Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322)	No
Secondary	Number of Participants With Remission Based on Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score at Double-blind Phase Week 26	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. Remission defined as HAM-D17 total score =7.	Double-blind phase Week 26 (Study Day 322)	No
Secondary	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.	Double-blind phase Baseline (Study Day 140), Week 14 (Study Day 238), Week 26 (Study Day 322)	No
Secondary	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.	Double-blind phase Baseline (Study Day 140), Week 14 (Study Day 238), Week 26 (Study Day 322)	No

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