Major Depressive Disorder (MDD)Phase 3NCT00051259
Effects of Antidepressants on Sexual Functioning
A Phase 3 study testing Extended-Release Bupropion Hydrochloride in people with Major Depressive Disorder (MDD), run by GlaxoSmithKline at 23 sites in United States.
Trial summary
The purpose of this trial is to study the effects of two depression medications on sexual functioning. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- Extended-Release Bupropion Hydrochloride
- How many people
- 420 participants
- Where
- 23 sitesUnited States
- Study dates
- Jan 2003to Jun 2004
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary diagnosis of Major Depressive Disorder (MDD) with current duration lasting 12 weeks but no greater than 2 years.
- Subjects must engage in sexual activity that leads to orgasm at least once every two weeks.
- Subject must have normal orgasmic function and be willing to discuss with investigator.
Who cannot join
- Subjects that have arousal or orgasm dysfunction.
- Has previously failed to respond to two adequate trials of antidepressants in past 2 years.
- Subject has other unstable medical disorders.
- Subject has a positive urine test for illicit drug use at screening.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
GSK Investigational Site
Baltimore, Maryland, 21208
GSK Investigational Site
Bellaire, Texas, 77401
GSK Investigational Site
Berkeley, California, 94709
GSK Investigational Site
Beverly Hills, California, 90210
GSK Investigational Site
Charleston, South Carolina, 29407
GSK Investigational Site
Charlottesville, Virginia, 22908
GSK Investigational Site
Cleveland, Ohio, 44109
GSK Investigational Site
Coral Springs, Florida, 33065
GSK Investigational Site
Eugene, Oregon, 97401
GSK Investigational Site
Indianapolis, Indiana, 46202
GSK Investigational Site
Jacksonville, Florida, 32216
GSK Investigational Site
La Mesa, California, 91942
GSK Investigational Site
Lincoln, Rhode Island, 02865-4208
GSK Investigational Site
Madison, Wisconsin, 53719
GSK Investigational Site
Minneapolis, Minnesota, 55454
GSK Investigational Site
New York, New York, 10021
GSK Investigational Site
Oceanside, California, 92056
GSK Investigational Site
Portland, Oregon, 97210
GSK Investigational Site
Richmond, Virginia, 23294
GSK Investigational Site
Rockville, Maryland, 20852
GSK Investigational Site
Terre Haute, Indiana, 47802
GSK Investigational Site
Toledo, Ohio, 43623
GSK Investigational Site
Tulsa, Oklahoma, 74135
About this study
Official title: A Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Effects on Sexual Functioning of Extended-Release Bupropion Hydrochloride (300-450mg) and Escitalopram (10-20mg) in Outpatients With Moderate to Severe Major Depression Over an Eight-Week Treatment Period
The purpose of this trial is to study the effects of two depression medications on sexual functioning.
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- Extended-Release Bupropion Hydrochloride
- Keywords
- depression, MDD, sexual dysfunction, orgasm disorder
- Medical subject headings
- Depressive Disorder, Major, Depression, Sexual Dysfunction, Physiological, Sexual Dysfunctions, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended-Release Bupropion HydrochlorideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with orgasm dysfunction. Change in HAMD-17 total score.
Secondary outcomes (1)
Percent of subjects in remission, HAMD-17. Changes in Sexual Functioning Questionnaire. Percent of responders, HAMD-17 CGI-I and CGI-S.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2003 (estimated)
- Study startJan 2003
- Primary completionJun 2004
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 420 participants
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, MD, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00051259
- Sponsor's protocol ID
- AK130926
- Status last verified
- Oct 2010
- First submitted
- 7 Jan 2003
- Last updated
- 4 Oct 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Effects on Sexual Functioning of Extended-Release Bupropion Hydrochloride (300-450mg) and Escitalopram (10-20mg) in Outpatients With Moderate to Severe Major Depression Over an Eight-Week Treatment Period
- ClinicalTrials.gov ID
- NCT00051259
- Acronym / sponsor ID
- AK130926
- Conditions
- Major Depressive Disorder (MDD)
- Keywords
- depression, MDD, sexual dysfunction, orgasm disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jan 2003
- Primary completion
- Jun 2004 (actual)
- Study completion
- Jun 2004 (actual)
- First posted
- 8 Jan 2003 (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.
The purpose of this trial is to study the effects of two depression medications on sexual functioning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary diagnosis of Major Depressive Disorder (MDD) with current duration lasting 12 weeks but no greater than 2 years.
- Subjects must engage in sexual activity that leads to orgasm at least once every two weeks.
- Subject must have normal orgasmic function and be willing to discuss with investigator.
Key exclusion criteria (4 listed)
- Subjects that have arousal or orgasm dysfunction.
- Has previously failed to respond to two adequate trials of antidepressants in past 2 years.
- Subject has other unstable medical disorders.
- Subject has a positive urine test for illicit drug use at screening.
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 |
|---|---|---|
| Extended-Release Bupropion Hydrochloride | Drug | – |
Primary outcome
Percentage of subjects with orgasm dysfunction. Change in HAMD-17 total score.
1 secondary outcome
Percent of subjects in remission, HAMD-17. Changes in Sexual Functioning Questionnaire. Percent of responders, HAMD-17 CGI-I and CGI-S.
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 4 Oct 2010.
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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, MD study director
GlaxoSmithKline
23 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 Extended-Release Bupropion Hydrochloride in people with Major Depressive Disorder (MDD), run by GlaxoSmithKline at 23 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 3 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 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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. 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?
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?
Percentage of subjects with orgasm dysfunction. Change in HAMD-17 total score.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2010.