Major Depressive DisorderPhase 4NCT01432457

Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) in Adult Outpatients With Major Depressive Disorder (MDD)

A Phase 4 study testing desvenlafaxine succinate sustained-release 50 mg/day and desvenlafaxine succinate sustained-release 100 mg/day in people with Major Depressive Disorder, run by Pfizer at 61 sites in United States.

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

A multicenter, 8-week study to evaluate the efficacy of 2 doses (50 and 100 mg/day) of desvenlafaxine succinate sustained-release (DVS SR) versus placebo in adult outpatients with major depressive disorder. 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/day and desvenlafaxine succinate sustained-release 100 mg/day
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 924 participants
Where: 61 sitesUnited States
Study dates: Oct 2011to Aug 2012
Phase: Phase 4
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

Male or female outpatients aged 18 years or older who are fluent in written and spoken English.
A primary diagnosis of MDD based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM- IV-TR), single or recurrent episode, without psychotic features.
A HAM-D17 total score ≥20 at the screening and baseline (study day -1) visits and no more than a 4-point improvement from screening to baseline.

Who cannot join

Significant risk of suicide based on clinical judgment.
Current (within 12 months before baseline) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder.
Current generalized anxiety disorder, panic disorder, or social anxiety disorder.
History or current evidence of gastrointestinal disease known to interfere with the absorption or excretion of drugs or a history of surgery known to interfere with the absorption or excretion of drugs.
Any unstable hepatic, renal, pulmonary, cardiovascular, ophthalmologic, neurologic, or other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results.

Trial locations and contacts

61 sites in 1 country.

City, postcode or hospital

61 sites in 1 country

United States61 sites

Lehigh Center for Clinical Research
Allentown, Pennsylvania, 18104
Pacific Clinical Research Medical Group
Arcadia, California, 91007
Atlanta Center for Medical Research
Atlanta, Georgia, 30308
Comprehensive NeuroScience, Incorporated
Atlanta, Georgia, 30328
FutureSearch Trials
Austin, Texas, 78731
Pharmasite Research Inc
Baltimore, Maryland, 21208
NorthCoast Clinical Trials Inc.
Beachwood, Ohio, 44122
Southwestern Research, Incorporated
Beverly Hills, California, 90210
Social Psychiatry Research Institute
Brooklyn, New York, 11235
Neuro-Behavioral Clinical Research, Inc.
Canton, Ohio, 44718
Neurobehavioral Research, Inc
Cedarhurst, New York, 11516
Patient Priority Clinical Sites, LLC
Cincinnati, Ohio, 45215
Carolina Clinical Research Services
Columbia, South Carolina, 29201
Clinical Innovations, Inc.
Costa Mesa, California, 92626
KRK Medical Research
Dallas, Texas, 75230
FutureSearch Trials of Dallas
Dallas, Texas, 75231
Midwest Clinical Research Center
Dayton, Ohio, 45417
Synergy Clinical Research of Escondido
Escondido, California, 92027
Prairie St. Johns Clinic - Fargo
Fargo, North Dakota, 58103
Odyssey Research
Fargo, North Dakota, 58104
Plains Medical Clinic
Fargo, North Dakota, 58104
Red Oak Psychiatry Associates, PA
Houston, Texas, 77090
Clinical Neuroscience Solutions Incorporated
Jacksonville, Florida, 32216
Joliet Center for Clinical Research
Joliet, Illinois, 60435
Eastside Therapeutic Resource
Kirkland, Washington, 98033
Accurate Clinical Trials, Inc.
Kissimmee, Florida, 34741
Capstone Clinical Research
Libertyville, Illinois, 60048
Lincoln Research
Lincoln, Rhode Island, 02865
Arkansas Psychiatric Clinic Clinical Research Trials, P.A.
Little Rock, Arkansas, 72223
Florida Clinical Research Center, LLC
Maitland, Florida, 32751
CRI Worldwide, LLC
Marlton, New Jersey, 08053
Suburban Research Associates
Media, Pennsylvania, 19063
Radiant Research, Inc.
Murray, Utah, 84123
AMR-Baber Research Inc.
Naperville, Illinois, 60563
Synergy Clinical Research Center
National City, California, 91950
Eastside Comprehensive Medical Center, LLC
New York, New York, 10021
Medical and Behavioral Health Research Pc
New York, New York, 10023
Heartland Pharma Development
North Platte, Nebraska, 69101
American Medical Research, Inc.
Oak Brook, Illinois, 60523
Pacific Research Partners
Oakland, California, 94612
Cutting Edge Research Group
Oklahoma City, Oklahoma, 73116
Psychiatric Associates
Overland Park, Kansas, 66211
Pasadena Research Institute, LLC
Pasadena, California, 91106
CRI Worldwide, LLC
Philadelphia, Pennsylvania, 19139
Dedicated Clinical Research
Phoenix, Arizona, 85020
Deidcated Clinical Research
Phoenix, Arizona, 85020
Oregon Center for Clinical Investigations, Inc.
Portland, Oregon, 97210
Summit Research Network (Oregon), Inc.
Portland, Oregon, 97210
Clinical Innovations, Inc.
Riverside, California, 92506
Midwest Research Group
Saint Charles, Missouri, 63301
Affiliated Research Institute
San Diego, California, 92108
Clinical Innovations, Inc.
San Diego, California, 92121
Summit Research Network (Seattle) LLC
Seattle, Washington, 98104
California Neuroscience Research Medical Group, Inc
Sherman Oaks, California, 91403
Carman Research
Smyrna, Georgia, 30080
Comprehensive NeuroScience, Inc.
St. Petersburg, Florida, 33716
Viking Clinical Research Center
Temecula, California, 92591
Collaborative Neuroscience Network, Inc. South Bay
Torrance, California, 90502
Pacific Clinical Research Medical Group
Upland, California, 91786
Janus Center for Psychiatric Research
West Palm Beach, Florida, 33407
Via Christi Research
Wichita, Kansas, 67214

Other trials in United States

About this study

Official title: A Phase IV, Multicenter, Randomized, 8-Week, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy of 2 Fixed Doses (50 and 100 mg/Day) of Desvenlafaxine Succinate Sustained-Release (DVS SR) in Adult Outpatients With Major Depressive Disorder

Conditions: Major Depressive Disorder
Being tested: desvenlafaxine succinate sustained-release 50 mg/day, desvenlafaxine succinate sustained-release 100 mg/day, placebo
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 mg/dayDrug
Also called Pristiq
50 mg tablets of DVS SR taken orally once daily for 8 weeks; 1 week of placebo taper
desvenlafaxine succinate sustained-release 100 mg/dayDrug
100 mg tablets of DVS SR taken orally once daily for 8 weeks (which includes 1 week of titration at 50 mg/day); 1 week of taper at 50 mg/day
placeboDrug
50 mg and 100 mg placebo matching tablets taken orally once daily for 8 weeks; 1 week of placebo taper

Study groups in NCT01432457
Study group	Role	What they receive
desvenlafaxine succinate sustained-release 50 mg/day	Experimental	Not described Receives: Drug: desvenlafaxine succinate sustained-release 50 mg/day
desvenlafaxine succinate sustained-release 100 mg/day	Experimental	Not described Receives: Drug: desvenlafaxine succinate sustained-release 100 mg/day
Placebo	Placebo comparator	Not described Receives: Drug: placebo

What is being measured

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

Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8
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). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. Change from baseline: score at observation minus score at baseline.
Measured: Baseline to Week 8 (final on-therapy)
Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8
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). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. Change from baseline: score at observation minus score at baseline
Measured: Baseline to Week 8 (final on-therapy)

Secondary outcomes (6)

Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I)
CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Higher score = worse outcome.
Measured: Baseline to Week 8 (final on-therapy)
Change From Baseline on the Clinical Global Impression-Severity Score (CGI-S)
CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = worse state.
Measured: Baseline to Week 8 (final on-therapy)
Change From Baseline on the Clinical Global Impression-Severity (CGI-S) Score
CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = worse state.
Measured: Baseline to Week 8 (final on-therapy)
Hamilton Rating Scale for Depression, 17-item (HAM-D17) Response Rate
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). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. A response is defined as ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression (HAM-D17) total score.
Measured: Baseline to Week 8 (final on-therapy)
Hamilton Rating Scale for Depression, 17-item (HAM-D17) Remission Rate
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). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) total score of ≤ 7.
Measured: Baseline to week 8 (final on-therapy)
Change From Baseline on the Arizona Sexual Experiences (ASEX) Scale Total Score
The ASEX scale has 5 items to assess sexual functioning with a 1-week recall period. The 5 items assess sex drive, ease of arousal, ease of erection/lubrication, ease of orgasm and orgasm satisfaction. Subjects were encouraged to complete all 5 items regardless of sexual activity during the past week. However, all analyses utilized only the data for the visits where the presence of sexual activity was indicated.
Each individual score ranged from 1 to 6; the total score (based on the sum of the individual items) ranged from 5 to 30; higher scores indicated worse sexual function.
Measured: Baseline to Week 8 (final on-therapy)

Timeline

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

Oct 2011Aug 2012

First posted13 Sep 2011 (estimated)
Study startOct 2011
Primary completionJul 2012
Study completionAug 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 924 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01432457
Sponsor's protocol ID: B2061028
Other IDs: 3151A1-4420
Status last verified: Dec 2013
First submitted: 9 Sep 2011
Last updated: 20 Jan 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Zilcha-Mano S, Wang X, Wajsbrot DB, Boucher M, Fine SA, Rutherford BR. Trajectories of Function and Symptom Change in Desvenlafaxine Clinical Trials: Toward Personalized Treatment for Depression. J Clin Psychopharmacol. 2021 Sep-Oct 01;41(5):579-584. doi: 10.1097/JCP.0000000000001435.
PubMed 34183490
McIntyre RS, Fayyad R, Mackell JA, Boucher M. Effect of metabolic syndrome and thyroid hormone on efficacy of desvenlafaxine 50 and 100 mg/d in major depressive disorder. Curr Med Res Opin. 2016;32(3):587-99. doi: 10.1185/03007995.2015.1136603. Epub 2016 Jan 13.
PubMed 26709542
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
Clayton AH, Tourian KA, Focht K, Hwang E, Cheng RF, Thase ME. Desvenlafaxine 50 and 100 mg/d versus placebo for the treatment of major depressive disorder: a phase 4, randomized controlled trial. J Clin Psychiatry. 2015 May;76(5):562-9. doi: 10.4088/JCP.13m08978.
PubMed 25375652

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)

All Major Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IV, Multicenter, Randomized, 8-Week, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy of 2 Fixed Doses (50 and 100 mg/Day) of Desvenlafaxine Succinate Sustained-Release (DVS SR) in Adult Outpatients With Major Depressive Disorder
ClinicalTrials.gov ID: NCT01432457
Acronym / sponsor ID: B2061028
Conditions: Major Depressive Disorder
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 924 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Oct 2011
Primary completion: Jul 2012 (actual)
Study completion: Aug 2012 (actual)
First posted: 13 Sep 2011 (estimated)
Results: Posted 20 Jan 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
desvenlafaxine succinate sustained-release 50 mg/day	Experimental	Drug: desvenlafaxine succinate sustained-release 50 mg/day
desvenlafaxine succinate sustained-release 100 mg/day	Experimental	Drug: desvenlafaxine succinate sustained-release 100 mg/day
Placebo	Placebo comparator	Drug: placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Male or female outpatients aged 18 years or older who are fluent in written and spoken English.
A primary diagnosis of MDD based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM- IV-TR), single or recurrent episode, without psychotic features.
A HAM-D17 total score ≥20 at the screening and baseline (study day -1) visits and no more than a 4-point improvement from screening to baseline.

Key exclusion criteria (5 listed)

Significant risk of suicide based on clinical judgment.
Current (within 12 months before baseline) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder.
Current generalized anxiety disorder, panic disorder, or social anxiety disorder.
History or current evidence of gastrointestinal disease known to interfere with the absorption or excretion of drugs or a history of surgery known to interfere with the absorption or excretion of drugs.
Any unstable hepatic, renal, pulmonary, cardiovascular, ophthalmologic, neurologic, or other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
desvenlafaxine succinate sustained-release 50 mg/dayAlso: Pristiq50 mg tablets of DVS SR taken orally once daily for 8 weeks; 1 week of placebo taper	Drug	desvenlafaxine succinate sustained-release 50 mg/day
desvenlafaxine succinate sustained-release 100 mg/day100 mg tablets of DVS SR taken orally once daily for 8 weeks (which includes 1 week of titration at 50 mg/day); 1 week of taper at 50 mg/day	Drug	desvenlafaxine succinate sustained-release 100 mg/day
placebo50 mg and 100 mg placebo matching tablets taken orally once daily for 8 weeks; 1 week of placebo taper	Drug	Placebo

Primary outcome

Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8
Time frame: Baseline to Week 8 (final on-therapy)
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). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. Change from baseline: score at observation minus score at baseline.
Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8
Time frame: Baseline to Week 8 (final on-therapy)
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). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. Change from baseline: score at observation minus score at baseline

6 secondary outcomes

Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I)
Time frame: Baseline to Week 8 (final on-therapy)
Change From Baseline on the Clinical Global Impression-Severity Score (CGI-S)
Time frame: Baseline to Week 8 (final on-therapy)
Change From Baseline on the Clinical Global Impression-Severity (CGI-S) Score
Time frame: Baseline to Week 8 (final on-therapy)
Hamilton Rating Scale for Depression, 17-item (HAM-D17) Response Rate
Time frame: Baseline to Week 8 (final on-therapy)
Hamilton Rating Scale for Depression, 17-item (HAM-D17) Remission Rate
Time frame: Baseline to week 8 (final on-therapy)
Change From Baseline on the Arizona Sexual Experiences (ASEX) Scale Total Score
Time frame: Baseline to Week 8 (final on-therapy)

Results and safety

Results posted to the registry on 20 Jan 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	306	269
DVS SR 50 mg	306	258
DVS SR 100 mg	312	253

Primary outcome: Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8

Time frame: Baseline to Week 8 (final on-therapy). Mean (Standard Error). Unit: Units on a scale

Measure	Placebo n = 267	DVS SR 50 mg n = 257	DVS SR 100 mg n = 252
Value	-9.71 (0.42)	-11.28 (0.42)	-11.67 (0.42)

Placebo vs DVS SR 50 mg: Adjusted Mean Difference: 1.57 (95% CI 0.44 to 2.69), p = 0.006, Mixed Models Analysis
Placebo vs DVS SR 100 mg: Adjusted Mean Difference: 1.96 (95% CI 0.84 to 3.08), p < 0.001, Mixed Models Analysis

Population analysed: Intent-To-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least 1 post-baseline HAM-D17 total score. Imputation technique: A mixed effects model for repeated measures (MMRM) was used with the baseline HAM-D17 score as a covariate.

Primary outcome: Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8

Time frame: Baseline to Week 8 (final on-therapy). Mean (Standard Error). Unit: Units on a scale

Measure	Placebo n = 294	DVS SR 50 mg n = 291	DVS SR 100 mg n = 301
Value	-9.50 (0.44)	-10.86 (0.43)	-11.16 (0.43)

Placebo vs DVS SR 50 mg: Adjusted Mean Difference: 1.36 (95% CI 0.28 to 2.45), p = 0.014, ANCOVA
Placebo vs DVS SR 100 mg: Adjusted Mean Difference: 1.67 (95% CI 0.59 to 2.74), p = 0.002, ANCOVA

Population analysed: Intent-To-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least 1 post-baseline HAM-D17 total score. Imputation technique: Analysis of covariance (ANCOVA) was used based on last-observation-carried-forward (LOCF) data.

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	6 of 300 (2%)	110 of 300 (36.7%)	Not reported
DVS SR 50 mg	2 of 300 (0.7%)	159 of 300 (53%)	Not reported
DVS SR 100 mg	2 of 309 (0.6%)	163 of 309 (52.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34183490Zilcha-Mano S, Wang X, Wajsbrot DB, Boucher M, Fine SA, Rutherford BR. Trajectories of Function and Symptom Change in Desvenlafaxine Clinical Trials: Toward Personalized Treatment for Depression. J Clin Psychopharmacol. 2021 Sep-Oct 01;41(5):579-584. doi: 10.1097/JCP.0000000000001435.
Derived from this study: PubMed 26709542McIntyre RS, Fayyad R, Mackell JA, Boucher M. Effect of metabolic syndrome and thyroid hormone on efficacy of desvenlafaxine 50 and 100 mg/d in major depressive disorder. Curr Med Res Opin. 2016;32(3):587-99. doi: 10.1185/03007995.2015.1136603. Epub 2016 Jan 13.
Derived from this study: PubMed 25758058Thase 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.
Derived from this study: PubMed 25375652Clayton AH, Tourian KA, Focht K, Hwang E, Cheng RF, Thase ME. Desvenlafaxine 50 and 100 mg/d versus placebo for the treatment of major depressive disorder: a phase 4, randomized controlled trial. J Clin Psychiatry. 2015 May;76(5):562-9. doi: 10.4088/JCP.13m08978.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Major Depressive Disorder

Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

61 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 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 20 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 sites in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 20 Jan 2014). 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?

Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8 (time frame: Baseline to Week 8 (final on-therapy)). The study lists 2 primary outcomes in all. 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 NCT01432457, which also lists 4 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 20 Jan 2014.