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Major Depressive DisorderPhase 3NCT00887224

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

A Phase 3 study testing Desvenlafaxine succinate sustained release 50 mg and Desvenlafaxine succinate sustained release 25 mg in people with Major Depressive Disorder, run by Pfizer at 90 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Major Depressive Disorder
What is being tested?
Desvenlafaxine succinate sustained release 50 mg and Desvenlafaxine succinate sustained release 25 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
874 participants
Where
90 sitesin 14 countries
Study dates
Jun 2009to Mar 2011
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

90 sites in 14 countries.

90 sites in 14 countries

United States21 sites

  • Pfizer Investigational Site

    Atlanta, Georgia, 30328

  • Pfizer Investigational Site

    Aurora, Colorado, 80045

  • Pfizer Investigational Site

    Beverly Hills, California, 90210

  • Pfizer Investigational Site

    Dayton, Ohio, 45408

  • Pfizer Investigational Site

    Encino, California, 91316

  • Pfizer Investigational Site

    Hoffman Estates, Illinois, 60169

  • Pfizer Investigational Site

    Jacksonville, Florida, 32256

  • Pfizer Investigational Site

    Los Alamitos, California, 90720

  • Pfizer Investigational Site

    New York, New York, 10024

  • Pfizer Investigational Site

    New York, New York, 10128

  • Pfizer Investigational Site

    Orange, California, 92868

  • Pfizer Investigational Site

    Portland, Oregon, 97210

  • Pfizer Investigational Site

    Rochester, New York, 14618

  • Pfizer Investigational Site

    Rockville, Maryland, 20852

  • Pfizer Investigational Site

    San Antonio, Texas, 78247

  • Pfizer Investigational Site

    Seattle, Washington, 98104

  • Pfizer Investigational Site

    Smyrna, Georgia, 30080

  • Pfizer Investigational Site

    South Miami, Florida, 33143

  • Pfizer Investigational Site

    St. Petersburg, Florida, 33702

  • Pfizer Investigational Site

    St. Petersburg, Florida, 33716

  • Pfizer Investigational Site

    Upland, California, 91786

Other trials in United States

Canada11 sites

  • Pfizer Investigational Site

    Bathurst, New Brunswick, E2A 4X7

  • Pfizer Investigational Site

    Burlington, Ontario, L7R 4E2

  • Pfizer Investigational Site

    Edmonton, Alberta, T6L 6W6

  • Pfizer Investigational Site

    Gatineau, Quebec, J9A 1K7

  • Pfizer Investigational Site

    Kelowna, British Columbia, V1Y 1Z9

  • Pfizer Investigational Site

    Medicine Hat, Alberta, T1B 4E7

  • Pfizer Investigational Site

    Ottawa, Ontario, K1G 4G3

  • Pfizer Investigational Site

    Pointe-Claire, Quebec, H9R 4S3

  • Pfizer Investigational Site

    Sherbrooke, Quebec, J1H 4J6

  • Pfizer Investigational Site

    Toronto, Ontario, M9W 4L6

  • Pfizer Investigational Site

    Vancouver, British Columbia, V6Z 2L4

Other trials in Canada

Finland7 sites

  • Pfizer Investigational Site

    Espoo, 02600

  • Pfizer Investigational Site

    Helsinki, 00100

  • Pfizer Investigational Site

    Joensuu, 80100

  • Pfizer Investigational Site

    Kuopio, 70110

  • Pfizer Investigational Site

    Seinäjoki, 60100

  • Pfizer Investigational Site

    Tampere, 33100

  • Pfizer Investigational Site

    Turku, 20100

Other trials in Finland

France6 sites

  • Pfizer Investigational Site

    Caen, 14000

  • Pfizer Investigational Site

    Dole, 39100

  • Pfizer Investigational Site

    Douai, France, 59500

  • Pfizer Investigational Site

    Douai, 59500

  • Pfizer Investigational Site

    Orvault, 44700

  • Pfizer Investigational Site

    Rennes, 35000

Other trials in France

Lithuania6 sites

  • Pfizer Investigational Site

    Kaunas, 3000

  • Pfizer Investigational Site

    Kaunas, LT-50185

  • Pfizer Investigational Site

    Vilius

  • Pfizer Investigational Site

    Vilnius, 10204

  • Pfizer Investigational Site

    Vilnius, LT-09112

  • Pfizer Investigational Site

    Vilnius, LT-10204

Other trials in Lithuania

Poland6 sites

  • Pfizer Investigational Site

    Skorzewo, Poznan, 60-185

  • Pfizer Investigational Site

    Szczecin, 71-460

  • Pfizer Investigational Site

    Torun, 87-100

  • Pfizer Investigational Site

    Tuszyn, 95-080

  • Pfizer Investigational Site

    Wroclaw, 50-227

  • Pfizer Investigational Site

    Żuromin, 09-300

Other trials in Poland

Slovakia6 sites

  • Pfizer Investigational Site

    Bojnice, 972 01

  • Pfizer Investigational Site

    Bratislava, 820 07

  • Pfizer Investigational Site

    Liptovský Mikuláš, 031 23

  • Pfizer Investigational Site

    Michalovce, 071 01

  • Pfizer Investigational Site

    Rimavská Sobota, 979 12

  • Pfizer Investigational Site

    Trenčín, 91101

Other trials in Slovakia

Estonia5 sites

  • Pfizer Investigational Site

    Tallinn, 12618

  • Pfizer Investigational Site

    Tallinn

  • Pfizer Investigational Site

    Tartu, 51003

  • Pfizer Investigational Site

    Vöru, 65608

  • Pfizer Investigational Site

    Võru, 65608

Other trials in Estonia

Latvia5 sites

  • Pfizer Investigational Site

    Liepāja, LV-3400

  • Pfizer Investigational Site

    Sigulda, LV-2150

  • Pfizer Investigational Site

    Sigulda

  • Pfizer Investigational Site

    Strenči, Latvia, 4730

  • Pfizer Investigational Site

    Strenči, 4730

Other trials in Latvia

Romania5 sites

  • Pfizer Investigational Site

    Brasov, Brașov County, 500123

  • Pfizer Investigational Site

    Bucharest, 010825

  • Pfizer Investigational Site

    Bucharest, 041914

  • Pfizer Investigational Site

    Cluj-Napoca, 400012

  • Pfizer Investigational Site

    Craiova, Dolj, 200317

Other trials in Romania

Colombia4 sites

  • Pfizer Investigational Site

    Barranquilla, Atlántico

  • Pfizer Investigational Site

    Bogota, Cundinamarca

  • Pfizer Investigational Site

    Bucamaranga, Santander Department

  • Pfizer Investigational Site

    Medellín, Antioquia

Other trials in Colombia

Chile3 sites

  • Pfizer Investigational Site

    Santiago, Chile, 7530193

  • Pfizer Investigational Site

    Santiago, Chile, 7630000

  • Pfizer Investigational Site

    Santiago, Chile, 8330838

Other trials in Chile

South Africa3 sites

  • Pfizer Investigational Site

    Cape Town, Western Cape, 7530

  • Pfizer Investigational Site

    Durban, 3630

  • Pfizer Investigational Site

    Paarl, 7646

Other trials in South Africa

Croatia2 sites

  • Pfizer Investigational Site

    Rijeka, 51000

  • Pfizer Investigational Site

    Zagreb, 10000

Other trials in Croatia

About this study

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

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.

Being tested
Desvenlafaxine succinate sustained release 50 mg, Desvenlafaxine succinate sustained release 25 mg, Placebo
Keywords
Major Depressive Disorder
Medical subject headings
Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Desvenlafaxine succinate sustained release 50 mgDrug

    Also called Pristiq

    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 mgDrug

    Also called Pristiq

    25 mg tablet for taper, once daily for 1 week

  • PlaceboDrug

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

Study groups in NCT00887224
Study groupRoleWhat they receive
Desvenlafaxine succinate sustained release 50 mgExperimentalNot described
Receives: Drug: Desvenlafaxine succinate sustained release 50 mg; Drug: Desvenlafaxine succinate sustained release 25 mg
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

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

Secondary outcomes (7)

  1. 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.

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

  2. 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).

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

  3. 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.

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

  4. 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.

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

  5. 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.

    Measured: Double-blind phase Week 26 (Study Day 322)

  6. 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.

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

  7. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2009 (estimated)
  2. Study startJun 2009
  3. Primary completionMar 2011
  4. Study completionMar 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
874 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00887224
Sponsor's protocol ID
3151A1-3360
Other IDs
B2061004
Status last verified
May 2012
First submitted
22 Apr 2009
Last updated
21 Nov 2014
Data monitoring committee
No

Publications

  • 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.

    PubMed 26693033

  • 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.

    PubMed 26644956

  • 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.

    PubMed 26137355

  • 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.

    PubMed 25758058

  • 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.

    PubMed 23473348

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Desvenlafaxine succinate sustained release 50 mg and Desvenlafaxine succinate sustained release 25 mg in people with Major Depressive Disorder, run by Pfizer at 90 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 90 sites in United States, Canada, Finland, France, Lithuania and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Relapse Following Randomization to the Double-blind (DB) Phase: Estimated Probability (Percent) of Relapse at DB Day 185 (time frame: Double-blind phase Baseline (Study Day 140) up to DB Day 185 (Study Day 325)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00887224, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2014.

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