Major Depressive DisorderPhase 3NCT00831415

Study Evaluating Long-Term Safety of Desvenlafaxine Succinate Sustained Release With Japanese Adult Subjects in Major Depressive Disorder (MDD)

A Phase 3 study testing desvenlafaxine succinate sustained release tablets in people with Major Depressive Disorder, run by Pfizer at 17 sites in Japan.

Completed

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

Official record

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Trial summary

The primary objective of this study is to evaluate the long-term safety of desvenlafaxine succinate sustained release tablets during 10-month open-label treatment of Japanese subjects with major depressive disorder (MDD). Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Major Depressive Disorder
What is being tested?: desvenlafaxine succinate sustained release tablets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 304 participants
Where: 17 sitesJapan
Study dates: Mar 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 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Outpatients who have completed double-blind therapy in short-term study for the indication of major depressive disorder (MDD), including scheduled evaluations, with no major protocol violations and no study events that, in the opinion of the investigator, would preclude the subject's entry into the long-term, open-label study.

Who cannot join

Clinically important abnormalities on baseline (day 56 of the short-term study) physical examination, or any unresolved clinically significant abnormalities on electrocardiogram (ECG), laboratory test results, or vital signs recorded before day 56 in the previous short-term study for the indication of MDD.

Trial locations and contacts

17 sites in 1 country.

City, postcode or hospital

17 sites in 1 country

Japan17 sites

Pfizer Investigational Site
Aichi
Pfizer Investigational Site
Chiba
Pfizer Investigational Site
Fukuoka
Pfizer Investigational Site
Fukushima
Pfizer Investigational Site
Gunma
Pfizer Investigational Site
Hiroshima
Pfizer Investigational Site
Hokkaido
Pfizer Investigational Site
Hyōgo
Pfizer Investigational Site
Ishikawa
Pfizer Investigational Site
Kanagawa
Pfizer Investigational Site
Kumamoto
Pfizer Investigational Site
Kyoto
Pfizer Investigational Site
Osaka
Pfizer Investigational Site
Saga
Pfizer Investigational Site
Saitama
Pfizer Investigational Site
Shiga
Pfizer Investigational Site
Tokyo

Other trials in Japan

About this study

Official title: A 10-Month Open-Label Evaluation Of The Long-Term Safety Of Desvenlafaxine Succinate Sustained Release In Japanese Adults With Major Depressive Disorder

The secondary objective is to evaluate the long-term response of subjects receiving desvenlafaxine succinate sustained release tablets by clinical global evaluation, general well-being and absence of symptoms.

Conditions: Major Depressive Disorder
Being tested: desvenlafaxine succinate sustained release tablets
Keywords: Open-label Long-term extension study
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 tabletsDrug
Also called DVS-233; Pristiq
25-mg or 50-mg DVS SR tablets taken orally, once daily, at the same time each day. 100 mg dose will be supplied as 2 tablets of 50-mg tablet.

Study groups in NCT00831415
Study group	Role	What they receive
1	Experimental	DVS SR Receives: Drug: desvenlafaxine succinate sustained release tablets

What is being measured

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

Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score
HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3-point (0 to 2) or a 5-point scale (0 to 4) with 0=none/absent and 4=most severe, for a maximum total score of 50. Higher scores indicate greater severity. FOT evaluation is defined as the last "on-therapy" evaluation, regardless of the number of days on therapy. Analysis on Observed cases (non-missing data) and Last observation carried forward (LOCF); LOCF method of imputation for any missing value at any visit.
Measured: Baseline (Extension Study) up to Day 308 or Final On-Therapy (FOT) Evaluation
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
Any untoward medical occurrence in a participant who received study treatment was considered an AE without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be an SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly.
Measured: Baseline (Extension Study) up to Day 329 or 15 days after last dose of study treatment

Secondary outcomes (2)

Number of Participants With Categorical Scores on Clinical Global Impression-Improvement (CGI-I)
CGI-I is a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
Measured: Day 308 or FOT Evaluation
Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score
CGI-S is a 7-point clinician rated scale to assess severity of current illness state. Range is 1 (normal - not ill at all) to 7 (among the most extremely ill). Higher score = more affected.
Measured: Baseline (Extension Study) up to Day 308 or FOT Evaluation

Timeline

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

Mar 2009Mar 2011

First posted29 Jan 2009 (estimated)
Study startMar 2009
Primary completionMar 2011
Study completionMar 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.
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 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 304 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00831415
Sponsor's protocol ID: 3151A1-3350
Other IDs: B2061002
Status last verified: Nov 2018
First submitted: 27 Jan 2009
Last updated: 7 Dec 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 7 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 10-Month Open-Label Evaluation Of The Long-Term Safety Of Desvenlafaxine Succinate Sustained Release In Japanese Adults With Major Depressive Disorder
ClinicalTrials.gov ID: NCT00831415
Acronym / sponsor ID: 3151A1-3350
Conditions: Major Depressive Disorder
Keywords: Open-label Long-term extension study
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 304 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Mar 2009
Primary completion: Mar 2011 (actual)
Study completion: Mar 2011 (actual)
First posted: 29 Jan 2009 (estimated)
Results: Posted 30 Jan 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
1	Experimental	Drug: desvenlafaxine succinate sustained release tabletsDVS SR

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Outpatients who have completed double-blind therapy in short-term study for the indication of major depressive disorder (MDD), including scheduled evaluations, with no major protocol violations and no study events that, in the opinion of the investigator, would preclude the subject's entry into the long-term, open-label study.

Key exclusion criteria (1 listed)

Clinically important abnormalities on baseline (day 56 of the short-term study) physical examination, or any unresolved clinically significant abnormalities on electrocardiogram (ECG), laboratory test results, or vital signs recorded before day 56 in the previous short-term study for the indication of MDD.

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 tabletsAlso: DVS-233; Pristiq25-mg or 50-mg DVS SR tablets taken orally, once daily, at the same time each day. 100 mg dose will be supplied as 2 tablets of 50-mg tablet.	Drug	1

Primary outcome

Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score
Time frame: Baseline (Extension Study) up to Day 308 or Final On-Therapy (FOT) Evaluation
HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3-point (0 to 2) or a 5-point scale (0 to 4) with 0=none/absent and 4=most severe, for a maximum total score of 50. Higher scores indicate greater severity. FOT evaluation is defined as the last "on-therapy" evaluation, regardless of the number of days on therapy. Analysis on Observed cases (non-missing data) and Last observation carried forward (LOCF); LOCF method of imputation for any missing value at any visit.
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
Time frame: Baseline (Extension Study) up to Day 329 or 15 days after last dose of study treatment
Any untoward medical occurrence in a participant who received study treatment was considered an AE without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be an SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly.

2 secondary outcomes

Number of Participants With Categorical Scores on Clinical Global Impression-Improvement (CGI-I)
Time frame: Day 308 or FOT Evaluation
Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score
Time frame: Baseline (Extension Study) up to Day 308 or FOT Evaluation

Results and safety

Results posted to the registry on 30 Jan 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
DVS SR	304	229

Primary outcome: Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score

Time frame: Baseline (Extension Study) up to Day 308 or Final On-Therapy (FOT) Evaluation. Mean (95% Confidence Interval). Unit: scores on a scale

Measure	DVS SR n = 304
LOCF - change at FOT (n=304)	-4.76 (-5.47 to -4.05)
Observed cases - change at Day 308 (n=224)	-5.82 (-6.61 to -5.03)

Population analysed: Intent to treat (ITT): all enrolled participants who received at least 1 dose of study treatment in Extension Study and at least 1 available post-baseline evaluation for any endpoint; (n)=number of participants with analyzable data at observation.

Primary outcome: Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)

Time frame: Baseline (Extension Study) up to Day 329 or 15 days after last dose of study treatment. Number. Unit: percentage of participants

Measure	DVS SR n = 304
Adverse Events	81.3
Serious Adverse Events	2.6

Population analysed: Safety population: all enrolled participants who received at least 1 dose of study treatment in this extension study.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Events were collected from the time of the signing of the informed consent form up to 15 days after the last dose of study treatment was administered.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DVS SR	8 of 304 (2.6%)	247 of 304 (81.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing desvenlafaxine succinate sustained release tablets in people with Major Depressive Disorder, run by Pfizer at 17 sites in Japan.

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 1 inclusion and 1 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 7 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Japan. 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. 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 30 Jan 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 Psychiatric Scale for Depression-17 Item (HAM-D17) Score (time frame: Baseline (Extension Study) up to Day 308 or Final On-Therapy (FOT) Evaluation). 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 NCT00831415.

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 7 Dec 2018.