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

NCT00887224 | Completed Phase 3 Results

• 2 other identifiers: 3151A1-3360B2061004
• Study Type: interventional
• Target: 874
• Locations: 14 countries
• Sites: 90

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predetermined period of time, subjects will be selected by chance to either continue receiving the study drug or to be withdrawn from the study drug and receive placebo for the remainder of their participation in the trial.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 Subjects who do not respond to treatment, demonstrating no significant change in their depressive symptoms, will be withdrawn from participation at the end of this period.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

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (7)

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

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

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

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

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

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

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

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

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

  Double-blind phase Week 26 (Study Day 322)

Study Arms (2)

Desvenlafaxine succinate sustained release 50 mg

EXPERIMENTAL

Drug: Desvenlafaxine succinate sustained release 50 mg; Drug: Desvenlafaxine succinate sustained release 25 mg

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Desvenlafaxine succinate sustained release 50 mg DRUG

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.

Also known as: Pristiq

Desvenlafaxine succinate sustained release 50 mg

Desvenlafaxine succinate sustained release 25 mg DRUG

25 mg tablet for taper, once daily for 1 week

Also known as: Pristiq

Desvenlafaxine succinate sustained release 50 mg

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (90)

Pfizer Investigational Site

Beverly Hills, California, 90210, United States

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Encino, California, 91316, United States

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Los Alamitos, California, 90720, United States

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Orange, California, 92868, United States

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Upland, California, 91786, United States

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Aurora, Colorado, 80045, United States

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Jacksonville, Florida, 32256, United States

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South Miami, Florida, 33143, United States

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St. Petersburg, Florida, 33702, United States

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St. Petersburg, Florida, 33716, United States

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Atlanta, Georgia, 30328, United States

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Smyrna, Georgia, 30080, United States

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Hoffman Estates, Illinois, 60169, United States

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Rockville, Maryland, 20852, United States

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New York, New York, 10024, United States

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New York, New York, 10128, United States

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Rochester, New York, 14618, United States

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Dayton, Ohio, 45408, United States

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Portland, Oregon, 97210, United States

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San Antonio, Texas, 78247, United States

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Seattle, Washington, 98104, United States

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Edmonton, Alberta, T6L 6W6, Canada

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Medicine Hat, Alberta, T1B 4E7, Canada

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Kelowna, British Columbia, V1Y 1Z9, Canada

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Vancouver, British Columbia, V6Z 2L4, Canada

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Bathurst, New Brunswick, E2A 4X7, Canada

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Burlington, Ontario, L7R 4E2, Canada

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Ottawa, Ontario, K1G 4G3, Canada

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Toronto, Ontario, M9W 4L6, Canada

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Gatineau, Quebec, J9A 1K7, Canada

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Pointe-Claire, Quebec, H9R 4S3, Canada

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Sherbrooke, Quebec, J1H 4J6, Canada

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Santiago, Chile, 7530193, Chile

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Santiago, Chile, 7630000, Chile

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Santiago, Chile, 8330838, Chile

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Medellín, Antioquia, Colombia

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Barranquilla, Atlántico, Colombia

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Bogota, Cundinamarca, Colombia

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Bucamaranga, Santander Department, Colombia

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Rijeka, 51000, Croatia

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Zagreb, 10000, Croatia

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Tallinn, 12618, Estonia

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Tallinn, Estonia

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Tartu, 51003, Estonia

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Võru, 65608, Estonia

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Vöru, 65608, Estonia

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Espoo, 02600, Finland

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Helsinki, 00100, Finland

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Joensuu, 80100, Finland

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Kuopio, 70110, Finland

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Seinäjoki, 60100, Finland

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Tampere, 33100, Finland

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Turku, 20100, Finland

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Douai, France, 59500, France

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Caen, 14000, France

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Dole, 39100, France

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Douai, 59500, France

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Orvault, 44700, France

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Rennes, 35000, France

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Strenči, Latvia, 4730, Latvia

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Liepāja, LV-3400, Latvia

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Sigulda, LV-2150, Latvia

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Sigulda, Latvia

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Strenči, 4730, Latvia

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Kaunas, 3000, Lithuania

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Kaunas, LT-50185, Lithuania

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Vilius, Lithuania

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Vilnius, 10204, Lithuania

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Vilnius, LT-09112, Lithuania

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Vilnius, LT-10204, Lithuania

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Skorzewo, Poznan, 60-185, Poland

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Szczecin, 71-460, Poland

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Torun, 87-100, Poland

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Tuszyn, 95-080, Poland

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Wroclaw, 50-227, Poland

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Żuromin, 09-300, Poland

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Brasov, Brașov County, 500123, Romania

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Craiova, Dolj, 200317, Romania

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Bucharest, 010825, Romania

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Bucharest, 041914, Romania

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Cluj-Napoca, 400012, Romania

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Bojnice, 972 01, Slovakia

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Bratislava, 820 07, Slovakia

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Liptovský Mikuláš, 031 23, Slovakia

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Michalovce, 071 01, Slovakia

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Rimavská Sobota, 979 12, Slovakia

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Trenčín, 91101, Slovakia

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Cape Town, Western Cape, 7530, South Africa

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Durban, 3630, South Africa

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Paarl, 7646, South Africa

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Related Publications (5)

• 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.

  PMID: 26693033 DERIVED

• 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.

  PMID: 26644956 DERIVED

• 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.

  PMID: 26137355 DERIVED

• 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.

  PMID: 25758058 DERIVED

• 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.

  PMID: 23473348 DERIVED

Related Links

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

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Desvenlafaxine Succinate

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Lipids

Limitations and Caveats

P-value from the primary analysis is different from the one testing equality of relapse rates on Double-blind day 185. Estimated percentages were provided as representative descriptive measures. Medians were not estimable due to low relapse rates.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2009
• First Posted: April 23, 2009
• Study Start: June 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: November 21, 2014
• Results First Posted: June 27, 2012

Record last verified: 2012-05

Locations

FR (6); LA (5); CL (3); SL (6); PL (6); ZA (3); CO (4); ES (5); US (21); CR (2); RO (5); LI (6); FI (7); CA (11)