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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Major Depressive Disorder

Intervention: Desvenlafaxine succinate sustained release 50 mg (Drug); Desvenlafaxine succinate sustained release 25 mg (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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predetermined period of time, subjects will be selected by chance to either continue receiving the study drug or to be withdrawn from the study drug and receive placebo for the remainder of their participation in the trial.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 Subjects who do not respond to treatment, demonstrating no significant change in their depressive symptoms, will be withdrawn from participation at the end of this period.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

Clinical Details

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

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

Secondary outcome:

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

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

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

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

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

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Pfizer Investigational Site, Santiago 7530193, Chile

Pfizer Investigational Site, Santiago 7630000, Chile

Pfizer Investigational Site, Santiago 8330838, Chile

Pfizer Investigational Site, Rijeka 51000, Croatia

Pfizer Investigational Site, Zagreb 10000, Croatia

Pfizer Investigational Site, Tallinn 12618, Estonia

Pfizer Investigational Site, Tallinn, Estonia

Pfizer Investigational Site, Tartu 51003, Estonia

Pfizer Investigational Site, Voru 65608, Estonia

Pfizer Investigational Site, Vöru 65608, Estonia

Pfizer Investigational Site, Espoo 02600, Finland

Pfizer Investigational Site, Helsinki 00100, Finland

Pfizer Investigational Site, Joensuu 80100, Finland

Pfizer Investigational Site, Kuopio 70110, Finland

Pfizer Investigational Site, Seinajoki 60100, Finland

Pfizer Investigational Site, Tampere 33100, Finland

Pfizer Investigational Site, Turku 20100, Finland

Pfizer Investigational Site, Caen 14000, France

Pfizer Investigational Site, Dole 39100, France

Pfizer Investigational Site, Douai 59500, France

Pfizer Investigational Site, Orvault 44700, France

Pfizer Investigational Site, Rennes 35000, France

Pfizer Investigational Site, Liepaja LV-3400, Latvia

Pfizer Investigational Site, Sigulda LV-2150, Latvia

Pfizer Investigational Site, Sigulda, Latvia

Pfizer Investigational Site, Strenci 4730, Latvia

Pfizer Investigational Site, Kaunas 3000, Lithuania

Pfizer Investigational Site, Kaunas LT-50185, Lithuania

Pfizer Investigational Site, Vilius, Lithuania

Pfizer Investigational Site, Vilnius 10204, Lithuania

Pfizer Investigational Site, Vilnius LT-09112, Lithuania

Pfizer Investigational Site, Vilnius LT-10204, Lithuania

Pfizer Investigational Site, Szczecin 71-460, Poland

Pfizer Investigational Site, Torun 87-100, Poland

Pfizer Investigational Site, Tuszyn 95-080, Poland

Pfizer Investigational Site, Wroclaw 50-227, Poland

Pfizer Investigational Site, Zuromin 09-300, Poland

Pfizer Investigational Site, Brasov 500123, Romania

Pfizer Investigational Site, Bucharest 041914, Romania

Pfizer Investigational Site, Bucuresti 010825, Romania

Pfizer Investigational Site, Bucuresti 041914, Romania

Pfizer Investigational Site, Cluj Napoca 400012, Romania

Pfizer Investigational Site, Bojnice 972 01, Slovakia

Pfizer Investigational Site, Bratislava 820 07, Slovakia

Pfizer Investigational Site, Liptovsky Mikulas 031 23, Slovakia

Pfizer Investigational Site, Michalovce 071 01, Slovakia

Pfizer Investigational Site, Rimavska Sobota 979 12, Slovakia

Pfizer Investigational Site, Trencin 91101, Slovakia

Pfizer Investigational Site, Durban 3630, South Africa

Pfizer Investigational Site, Paarl 7646, South Africa

Pfizer Investigational Site, Edmonton, Alberta T6L 6W6, Canada

Pfizer Investigational Site, Medicine Hat, Alberta T1B 4E7, Canada

Pfizer Investigational Site, Medellin, Antioquia, Colombia

Pfizer Investigational Site, Barranquilla, Atlantico, Colombia

Pfizer Investigational Site, Kelowna, British Columbia V1Y 1Z9, Canada

Pfizer Investigational Site, Vancouver, British Columbia V6Z 2L4, Canada

Pfizer Investigational Site, Beverly Hills, California 90210, United States

Pfizer Investigational Site, Encino, California 91316, United States

Pfizer Investigational Site, Los Alamitos, California 90720, United States

Pfizer Investigational Site, Orange, California 92868, United States

Pfizer Investigational Site, Upland, California 91786, United States

Pfizer Investigational Site, Aurora, Colorado 80045, United States

Pfizer Investigational Site, Bogota, Cundinamarca, Colombia

Pfizer Investigational Site, Craiova, Dolj 200317, Romania

Pfizer Investigational Site, Jacksonville, Florida 32256, United States

Pfizer Investigational Site, South Miami, Florida 33143, United States

Pfizer Investigational Site, St. Petersburg, Florida 33702, United States

Pfizer Investigational Site, St. Petersburg, Florida 33716, United States

Pfizer Investigational Site, Atlanta, Georgia 30328, United States

Pfizer Investigational Site, Smyrna, Georgia 30080, United States

Pfizer Investigational Site, Hoffman Estates, Illinois 60169, United States

Pfizer Investigational Site, Rockville, Maryland 20852, United States

Pfizer Investigational Site, Bathurst, New Brunswick E2A 4X7, Canada

Pfizer Investigational Site, New York, New York 10024, United States

Pfizer Investigational Site, New York, New York 10128, United States

Pfizer Investigational Site, Rochester, New York 14618, United States

Pfizer Investigational Site, Dayton, Ohio 45408, United States

Pfizer Investigational Site, Burlington, Ontario L7R 4E2, Canada

Pfizer Investigational Site, Ottawa, Ontario K1G 4G3, Canada

Pfizer Investigational Site, Toronto, Ontario M9W 4L6, Canada

Pfizer Investigational Site, Portland, Oregon 97210, United States

Pfizer Investigational Site, Skorzewo, Poznan 60-185, Poland

Pfizer Investigational Site, Gatineau, Quebec J9A 1K7, Canada

Pfizer Investigational Site, Pointe-Claire, Quebec H9R 4S3, Canada

Pfizer Investigational Site, Sherbrooke, Quebec J1H 4J6, Canada

Pfizer Investigational Site, Bucamaranga, Santander, Colombia

Pfizer Investigational Site, San Antonio, Texas 78247, United States

Pfizer Investigational Site, Seattle, Washington 98104, United States

Pfizer Investigational Site, Cape Town, Western Cape 7530, South Africa

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: June 2009
Last updated: November 6, 2014

Page last updated: August 23, 2015

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