Major Depressive DisorderPhase 4NCT01121484

Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) In The Treatment Of Peri- And Postmenopausal Women With Major Depressive Disorder (DVS 3364)

A Phase 4 study testing desvenlafaxine succinate sustained-release in people with Major Depressive Disorder, run by Pfizer at 44 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, 10-week study to evaluate the efficacy and safety of 50 mg of desvenlafaxine succinate sustained-release formulation (DVS SR) versus placebo in the treatment of peri- and postmenopausal women with major depressive disorder Read more about this study

Who is it for?: Ages 40 to 70 years, women only
Conditions the study is for: Major Depressive Disorder
What is being tested?: desvenlafaxine succinate sustained-release
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 439 participants
Where: 44 sitesUnited States
Study dates: Jun 2010to Jun 2011
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 40 to 70 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Peri- and postmenopausal women aged 40 to 70 years who are fluent in both written and spoken English.
Postmenopausal status defined by 12 consecutive months of spontaneous amenorrhea; less than 12 consecutive months with at least 6 consecutive months of spontaneous amenorrhea and a pre-baseline follicle-stimulating hormone (FSH) level >40 mIU/mL; or 6 months postsurgical bilateral oophorectomy (with or without hysterectomy). Perimenopausal women defined by the presence of any of the following within 6 months before baseline:
an absolute change of 7 days or more in menstrual cycle length within 6 months before baseline;
a change in menstrual flow amount (2 or more flow categories, eg, from light or moderately light to moderately heavy or heavy);
a change in duration (absolute change of 2 or more days); or
periods of amenorrhea lasting at least 3 months.
A primary diagnosis of major depressive disorder (MDD) based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR), single or recurrent episode, without psychotic features using the modified Mini International Neuropsychiatric Interview (MINI).
A Montgomery and Asberg Depression Rating Scale (MADRS) total score >=25 at the screening and baseline (day -1) visits and no more than a 5-point improvement from screening to baseline.

Who cannot join

Treatment with DVS SR (Pristiq®) at any time in the past and/or venlafaxine, ie, Effexor® or Effexor XR®, 1 year prior to baseline.
Treatment-resistant; eg, in the past 3 years if any of the following treatments have failed: (a) 3 or more previous adequate trials of >=2 classes of antidepressant medication, (b) electroconvulsive therapy, or (c) 2 adequate trials of psychotherapy (eg, behavior therapy, behavior-marital therapy).
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.
Known presence of raised intraocular pressure or history of narrow-angle glaucoma.

Trial locations and contacts

44 sites in 1 country.

City, postcode or hospital

44 sites in 1 country

United States44 sites

Lehigh Center for Clinical Research
Allentown, Pennsylvania, 18104
Pacific Clinical Research Medical Group
Arcadia, California, 91007-3462
Emory University Department of Psychiatry and Behavioral Sciences
Atlanta, Georgia, 30306
Atlanta Center for Medical Research
Atlanta, Georgia, 30308
North Coast Clinical Trials, Inc.
Beechwood, Ohio, 44122
Northwest Clinical Research Center
Bellevue, Washington, 98007
Southwestern Research, Inc.
Beverly Hills, California, 90210
Birmingham Psychiatry Pharmaceutical Studies, Inc.
Birmingham, Alabama, 35226
Horizon Medical Services, PC
Bismarck, North Dakota, 58501
Legacy Pharma Research
Bismarck, North Dakota, 58501
Holston Medical Group
Bristol, Tennessee, 37620
Social Psychiatry Research Institute
Brooklyn, New York, 11235
Metrolina Medical Research
Charlotte, North Carolina, 28209
University of Virginia Health System Center for Psychiatric Clinical Research
Charlottesville, Virginia, 22903
Center For Emotional Fitness
Cherry Hill, New Jersey, 08002
Catalina Research Institute LLC
Chino, California, 91710
Carolina Clinical Research Services, LLC
Columbia, South Carolina, 29201
Connecticut Clinical Research
Cromwell, Connecticut, 06416
Midwest Clinical Research Center
Dayton, Ohio, 45417
Western Affiliated Research Institute
Denver, Colorado, 80209
Radiant Research, Inc.
Denver, Colorado, 80239
Bayou City Research, Ltd.
Houston, Texas, 77007
Westside Family Medical Center, P.C.
Kalamazoo, Michigan, 49009
Holston Medical Group
Kingsport, Tennessee, 37660
Radiant Research, Inc.
Las Vegas, Nevada, 89146
Capstone Clinical Research
Libertyville, Illinois, 60048
Arkansas Psychiatric Clinic Clinical Research Trials, P.A.
Little Rock, Arkansas, 72223
Medical & Behavioral Health Research PC
New York, New York, 10023
Deaconess Clinic Gateway Health Center Research Institute
Newburgh, Indiana, 47630
Pacific Clinical Research Medical Group
Orange, California, 92868
Robert Wood Johnson Medical School
Piscataway, New Jersey, 08854
Summit Research Network (Oregon), Inc.
Portland, Oregon, 97210
Nelson Clinic
Richmond, Virginia, 23298
Northwest Behavioral Research Center
Roswell, Georgia, 30076
Radiant Research, Inc.
San Antonio, Texas, 78229
Summit Research Network (Seattle) LLC
Seattle, Washington, 98104
Carman Research
Smyrna, Georgia, 30080
Comprehensive NeuroScience, Inc.
St. Petersburg, Florida, 33716
Stedman Clinical Trials, LLC
Tampa, Florida, 33613
Pacific Clinical Research Medical Group
Upland, California, 91786
Omega Medical Research
Warwick, Rhode Island, 02886
Independent Psychiatric Consultants, SC dba IPC Research
Waukesha, Wisconsin, 53188
Janus Center for Psychiatric Research
West Palm Beach, Florida, 33407
Via Christi Research
Witchita, Kansas, 67214

Other trials in United States

About this study

Official title: A Multicenter, Parallel-Group, Randomized, 10-Week, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of 50 mg Of DVS SR In The Treatment Of Peri- And Postmenopausal Women With Major Depressive Disorder

Conditions: Major Depressive Disorder
Being tested: desvenlafaxine succinate sustained-release, 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-releaseDrug
Also called Pristiq
50-mg DVS SR tablets taken orally once daily.
placeboDrug
Placebo tablets taken orally once daily.

Study groups in NCT01121484
Study group	Role	What they receive
desvenlafaxine succinate sustained-release	Experimental	Not described Receives: Drug: desvenlafaxine succinate sustained-release
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 in Hamilton Depression Scale (HAM-D17) at Week 8
HAM-D17, clinician-rated interview, measures presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, \& weight loss). Total score ranges from 0 to 52; higher scores indicate more severe depression. Change from baseline: score at observation minus score at baseline.
Measured: Baseline, Week 8

Secondary outcomes (5)

Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
CGI-I: 7-point scale in which the clinician rated how much the participant's condition has changed compared to baseline. Scores ranged 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. Higher score = more affected.
Measured: Week 8
Change From Baseline in Clinical Global Impression - Severity (CGI-S) at Week 8
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 = more affected. Change: score at observation minus score at baseline.
Measured: Baseline, Week 8
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score at Week 8
Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Change: score at observation minus score at baseline.
Measured: Baseline, Week 8
Change From Baseline in Quick Inventory of Depressive Symptoms, 16 Question Self-report (QIDS-SR)
This is a 16-item self reported questionnaire that measures depressive symptoms. Improvement reported as change in depressive score. Score ranges from 0 to 42, with higher numbers indicating more severe symptom reporting. Change: score at observation minus score at baseline.
Measured: Baseline, Week 8
Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Week 8
10 centimeter (cm) line (Visual Analog Scale) marked by participant. Intensity of pain range (over past week): 0 = no pain to 10 = worst possible pain. Change: score at observation minus score at baseline.
Measured: Baseline, Week 8

Timeline

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

Jun 2010Jun 2011

First posted12 May 2010 (estimated)
Study startJun 2010
Primary completionJun 2011
Study completionJun 2011

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 (8)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: 439 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01121484
Sponsor's protocol ID: 3151A1-3364
Other IDs: B2061029
Status last verified: Jan 2012
First submitted: 3 May 2010
Last updated: 4 Apr 2012
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
Soares CN, Zhang M, Boucher M. Categorical improvement in functional impairment in depressed patients treated with desvenlafaxine. CNS Spectr. 2019 Jun;24(3):322-332. doi: 10.1017/S1092852917000633. Epub 2017 Nov 15.
PubMed 29140227
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
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
Kornstein SG, Clayton AH, Bao W, Guico-Pabia CJ. A pooled analysis of the efficacy of desvenlafaxine for the treatment of major depressive disorder in perimenopausal and postmenopausal women. J Womens Health (Larchmt). 2015 Apr;24(4):281-90. doi: 10.1089/jwh.2014.4900.
PubMed 25860107
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
Soares CN, Endicott J, Boucher M, Fayyad RS, Guico-Pabia CJ. Predictors of functional response and remission with desvenlafaxine 50 mg/d in patients with major depressive disorder. CNS Spectr. 2014 Dec;19(6):519-27. doi: 10.1017/S1092852914000066. Epub 2014 Feb 26.
PubMed 24571916
Clayton AH, Kornstein SG, Dunlop BW, Focht K, Musgnung J, Ramey T, Bao W, Ninan PT. Efficacy and safety of desvenlafaxine 50 mg/d in a randomized, placebo-controlled study of perimenopausal and postmenopausal women with major depressive disorder. J Clin Psychiatry. 2013 Oct;74(10):1010-7. doi: 10.4088/JCP.12m08065.
PubMed 24229754

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

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All Major Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Parallel-Group, Randomized, 10-Week, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of 50 mg Of DVS SR In The Treatment Of Peri- And Postmenopausal Women With Major Depressive Disorder
ClinicalTrials.gov ID: NCT01121484
Acronym / sponsor ID: 3151A1-3364
Conditions: Major Depressive Disorder
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 439 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Jun 2010
Primary completion: Jun 2011 (actual)
Study completion: Jun 2011 (actual)
First posted: 12 May 2010 (estimated)
Results: Posted 30 Mar 2012

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: 2

Arm	Type	Receives
desvenlafaxine succinate sustained-release	Experimental	Drug: desvenlafaxine succinate sustained-release
Placebo	Placebo comparator	Drug: placebo

Who may qualify

Ages: 40 to 70 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Peri- and postmenopausal women aged 40 to 70 years who are fluent in both written and spoken English.
Postmenopausal status defined by 12 consecutive months of spontaneous amenorrhea; less than 12 consecutive months with at least 6 consecutive months of spontaneous amenorrhea and a pre-baseline follicle-stimulating hormone (FSH) level >40 mIU/mL; or 6 months postsurgical bilateral oophorectomy (with or without hysterectomy). Perimenopausal women defined by the presence of any of the following within 6 months before baseline:
A primary diagnosis of major depressive disorder (MDD) based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR), single or recurrent episode, without psychotic features using the modified Mini International Neuropsychiatric Interview (MINI).
A Montgomery and Asberg Depression Rating Scale (MADRS) total score >=25 at the screening and baseline (day -1) visits and no more than a 5-point improvement from screening to baseline.

Key exclusion criteria (4 listed)

Treatment with DVS SR (Pristiq®) at any time in the past and/or venlafaxine, ie, Effexor® or Effexor XR®, 1 year prior to baseline.
Treatment-resistant; eg, in the past 3 years if any of the following treatments have failed: (a) 3 or more previous adequate trials of >=2 classes of antidepressant medication, (b) electroconvulsive therapy, or (c) 2 adequate trials of psychotherapy (eg, behavior therapy, behavior-marital therapy).
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.
Known presence of raised intraocular pressure or history of narrow-angle glaucoma.

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-releaseAlso: Pristiq50-mg DVS SR tablets taken orally once daily.	Drug	desvenlafaxine succinate sustained-release
placeboPlacebo tablets taken orally once daily.	Drug	Placebo

Primary outcome

Change From Baseline in Hamilton Depression Scale (HAM-D17) at Week 8
Time frame: Baseline, Week 8
HAM-D17, clinician-rated interview, measures presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, \& weight loss). Total score ranges from 0 to 52; higher scores indicate more severe depression. Change from baseline: score at observation minus score at baseline.

5 secondary outcomes

Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
Time frame: Week 8
Change From Baseline in Clinical Global Impression - Severity (CGI-S) at Week 8
Time frame: Baseline, Week 8
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score at Week 8
Time frame: Baseline, Week 8
Change From Baseline in Quick Inventory of Depressive Symptoms, 16 Question Self-report (QIDS-SR)
Time frame: Baseline, Week 8
Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Week 8
Time frame: Baseline, Week 8

Results and safety

Results posted to the registry on 30 Mar 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Desvenlafaxine Succinate	218	185
Placebo	221	178

Primary outcome: Change From Baseline in Hamilton Depression Scale (HAM-D17) at Week 8

Time frame: Baseline, Week 8. Mean (Standard Deviation). Unit: Units on a scale

Measure	Desvenlafaxine Succinate n = 216	Placebo n = 216
Baseline	22.8 (3.29)	22.4 (3.51)
Change at Week 8	-9.7 (6.54)	-7.4 (6.74)

Desvenlafaxine Succinate vs Placebo: p = 0.004, ANCOVA

Population analysed: Full Analysis Set (FAS) Population: randomized participants who had a baseline HAM-D17 score, took at least 1 dose of investigational product, and had at least 1 postbaseline HAM-D17 evaluation. Last Observation Carried Forward (LOCF).

5 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
Desvenlafaxine Succinate	2 of 217 (0.9%)	100 of 217 (46.1%)	Not reported
Placebo	2 of 217 (0.9%)	90 of 217 (41.5%)	Not reported

Limitations and caveats (from the sponsor): Baseline characteristics are available for all treated participants (434) and not all randomized participants (439).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2012.
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 29140227Soares CN, Zhang M, Boucher M. Categorical improvement in functional impairment in depressed patients treated with desvenlafaxine. CNS Spectr. 2019 Jun;24(3):322-332. doi: 10.1017/S1092852917000633. Epub 2017 Nov 15.
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 26644956McIntyre 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.
Derived from this study: PubMed 25860107Kornstein SG, Clayton AH, Bao W, Guico-Pabia CJ. A pooled analysis of the efficacy of desvenlafaxine for the treatment of major depressive disorder in perimenopausal and postmenopausal women. J Womens Health (Larchmt). 2015 Apr;24(4):281-90. doi: 10.1089/jwh.2014.4900.
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 24571916Soares CN, Endicott J, Boucher M, Fayyad RS, Guico-Pabia CJ. Predictors of functional response and remission with desvenlafaxine 50 mg/d in patients with major depressive disorder. CNS Spectr. 2014 Dec;19(6):519-27. doi: 10.1017/S1092852914000066. Epub 2014 Feb 26.
Derived from this study: PubMed 24229754Clayton AH, Kornstein SG, Dunlop BW, Focht K, Musgnung J, Ramey T, Bao W, Ninan PT. Efficacy and safety of desvenlafaxine 50 mg/d in a randomized, placebo-controlled study of perimenopausal and postmenopausal women with major depressive disorder. J Clin Psychiatry. 2013 Oct;74(10):1010-7. doi: 10.4088/JCP.12m08065.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Major Depressive Disorder

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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

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing desvenlafaxine succinate sustained-release in people with Major Depressive Disorder, run by Pfizer at 44 sites in United States.

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 8 inclusion and 4 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 4 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 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 30 Mar 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?

Change From Baseline in Hamilton Depression Scale (HAM-D17) at Week 8 (time frame: Baseline, Week 8). 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 NCT01121484, which also lists 8 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 4 Apr 2012.