Depressive Disorder, MajorPhase 2NCT00102492

Study Of GW679769 In Major Depressive Disorder

A Phase 2 study testing GW679769 in people with Depressive Disorder, Major and Major Depressive Disorder (MDD), run by GlaxoSmithKline at 31 sites in 2 countries.

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

This is a placebo-controlled, fixed dose study that will evaluate the efficacy and safety of GW679769 in subjects with major depressive disorder. Read more about this study

Who is it for?: Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for: Depressive Disorder, Major, Major Depressive Disorder (MDD)
What is being tested?: GW679769
How many people: 356 participants
Where: 31 sitesin 2 countries
Study dates: Oct 2004to Sep 2006
Phase: Phase 2
Are there results?: None posted in the registry

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 to 64 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Subjects must have the ability to comprehend the key components of the consent form.
Subject must have met DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision) criteria for current MDE (major depressive episode) for at least 8 weeks prior to the Screening Visit.
If female, subjects must be practicing an acceptable method of birth control.
Subjects must have rating scores as outlined.

Who cannot join

Subjects whose symptoms of the MDE are better accounted for by another diagnosis.
Subjects with a history of schizophrenia, schizoaffective disorders or bipolar disorder.
Subjects have a positive urine test for illicit drug use and/or a history of substance abuse or alcohol dependence within the past 12 months.
Subjects with an unstable medical disorder.
If female, pregnant or lactating.
Subjects who have received ECT (electroconvulsive therapy) or TMS (transcranial magnetic stimulation) within the 6 months preceding screening or who have ever been homicidal.

Trial locations and contacts

31 sites in 2 countries.

Country

City, postcode or hospital

31 sites in 2 countries

United States27 sites

GSK Investigational Site
Austin, Texas, 78756
GSK Investigational Site
Beachwood, Ohio, 44122
GSK Investigational Site
Bellevue, Washington, 98004
GSK Investigational Site
Beverly Hills, California, 90210
GSK Investigational Site
Brooklyn, New York, 11235
GSK Investigational Site
Clementon, New Jersey, 08021
GSK Investigational Site
Eugene, Oregon, 97401
GSK Investigational Site
Farmington Hills, Michigan, 48336
GSK Investigational Site
Fort Lauderdale, Florida, 33301
GSK Investigational Site
Irving, Texas, 75039
GSK Investigational Site
Lake Jackson, Texas, 77566
GSK Investigational Site
Little Rock, Arkansas, 72223
GSK Investigational Site
Marietta, Georgia, 30060
GSK Investigational Site
Memphis, Tennessee, 38119
GSK Investigational Site
Miami, Florida, 33125
GSK Investigational Site
New York, New York, 10021
GSK Investigational Site
New York, New York, 10024
GSK Investigational Site
North Miami, Florida, 33161
GSK Investigational Site
Oakbrook Terrace, Illinois, 60181
GSK Investigational Site
Orlando, Florida, 32806
GSK Investigational Site
Portland, Oregon, 97209
GSK Investigational Site
Rockville, Maryland, 20852
GSK Investigational Site
Saint Charles, Missouri, 63301
GSK Investigational Site
Scottsdale, Arizona, 85251
GSK Investigational Site
Shreveport, Louisiana, 71104
GSK Investigational Site
Smyrna, Georgia, 30080
GSK Investigational Site
Winter Park, Florida, 32789

Other trials in United States

Canada4 sites

GSK Investigational Site
Edmonton, Alberta, T6L 5X8
GSK Investigational Site
Miramichi, New Brunswick, E1V 3G5
GSK Investigational Site
Mississauga, Ontario, L5M 4N4
GSK Investigational Site
Sherbrooke, Quebec, J1H 4J6

Other trials in Canada

About this study

Official title: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study Evaluating the Efficacy and Safety of GW679769 in Subjects With Major Depressive Disorder.

This is a placebo-controlled, fixed dose study that will evaluate the efficacy and safety of GW679769 in subjects with major depressive disorder.

Conditions: Depressive Disorder, Major, Major Depressive Disorder (MDD)
Being tested: GW679769
Keywords: Major Depressive Disorder, Major Depression, Mood Disorders, Major Depressive Episode
Medical subject headings: Depressive Disorder, Major, Mood Disorders

What participants receive

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

GW679769Drug

What is being measured

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

Change from baseline on the 17-item Hamilton Depression Rating Scale (HAM-D) total score at week 8, Last Observation Carried Forward.

Secondary outcomes (1)

CGI, HAM-A, QUIDS, SDS, MOS-12 Sleep Module, LSEQ, Safety and Tolerability, PK/PD

Timeline

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

Oct 2004Sep 2006

First posted31 Jan 2005 (estimated)
Study startOct 2004
Primary completionSep 2006
Study completionSep 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 356 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00102492
Sponsor's protocol ID: NKF100092
Status last verified: Apr 2015
First submitted: 29 Jan 2005
Last updated: 16 Apr 2015
Results posted: 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 Depressive Disorder, Major trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study Evaluating the Efficacy and Safety of GW679769 in Subjects With Major Depressive Disorder.
ClinicalTrials.gov ID: NCT00102492
Acronym / sponsor ID: NKF100092
Conditions: Depressive Disorder, Major, Major Depressive Disorder (MDD)
Keywords: Major Depressive Disorder, Major Depression, Mood Disorders, Major Depressive Episode
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 356 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Oct 2004
Primary completion: Sep 2006 (actual)
Study completion: Sep 2006 (actual)
First posted: 31 Jan 2005 (estimated)
Results: Not posted in the source record

Clinical summary

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

This is a placebo-controlled, fixed dose study that will evaluate the efficacy and safety of GW679769 in subjects with major depressive disorder.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Subjects must have the ability to comprehend the key components of the consent form.
Subject must have met DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision) criteria for current MDE (major depressive episode) for at least 8 weeks prior to the Screening Visit.
If female, subjects must be practicing an acceptable method of birth control.
Subjects must have rating scores as outlined.

Key exclusion criteria (6 listed)

Subjects whose symptoms of the MDE are better accounted for by another diagnosis.
Subjects with a history of schizophrenia, schizoaffective disorders or bipolar disorder.
Subjects have a positive urine test for illicit drug use and/or a history of substance abuse or alcohol dependence within the past 12 months.
Subjects with an unstable medical disorder.
If female, pregnant or lactating.

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
GW679769	Drug	–

Primary outcome

Change from baseline on the 17-item Hamilton Depression Rating Scale (HAM-D) total score at week 8, Last Observation Carried Forward.

1 secondary outcome

CGI, HAM-A, QUIDS, SDS, MOS-12 Sleep Module, LSEQ, Safety and Tolerability, PK/PD

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2015.

Related trials for Depressive Disorder, Major

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
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Acute Intermittent Hypoxia Therapy for Depression
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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.

GSK Clinical Trials study director

GlaxoSmithKline

31 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GW679769 in people with Depressive Disorder, Major and Major Depressive Disorder (MDD), run by GlaxoSmithKline at 31 sites in 2 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 4 inclusion and 6 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 16 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in United States, Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 17-item Hamilton Depression Rating Scale (HAM-D) total score at week 8, Last Observation Carried Forward.. 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 NCT00102492.

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 16 Apr 2015.