Depressive Disorder, MajorPhase 4NCT00316160
Sexual Functioning Study With Antidepressants
A Phase 4 study testing Bupropion Hydrochloride Extended-release and Extended-release Venlafaxine in people with Depressive Disorder, Major and Major Depressive Disorder (MDD), run by GlaxoSmithKline at 45 sites in United States.
Trial summary
Effects of two depression medication on sexual functioning Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Disorder, Major, Major Depressive Disorder (MDD)
- What is being tested?
- Bupropion Hydrochloride Extended-release and Extended-release Venlafaxine
- How many people
- 347 participants
- Where
- 45 sitesUnited States
- Study dates
- Sep 2004to May 2005
- Phase
- Phase 4
- 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)
- must have met DSM-IV criteria for current major depressive episode for at least 8 weeks but no long than 2 years.
- HAM-D17 total score of >17 at screening and baseline.
- Severity of illness score of >4 at screening and baseline.
- Willing to discuss sexual functioning with investigator or designee.
- Sexual activity that leads to orgasm at least every 2 weeks.
Who cannot join
- Past or current DSM-IV diagnosis of Bipolar Disorder I or II, schizophrenia or another psychotic disorder(s).
- Primary DSM-IV diagnosis or received treatment for Panic Disorder, Obsessive Compulsive Disorder or Post Stress Disorder within previous 12 months.
- Poses a homicidal or serious suicidal risk, have made an attempt within months prior to screening or who has ever been homicidal.
- Myocardial infarction with 1 year of screening.
- Taken ibupropion hydrochloride or venlafaxine in the last 6 months.
- Positive urine test for illicit drug use or alcohol or substance abuse within the past 12 months.
Show all 10Show fewer
- Psychotherapy within 3 months.
- Pregnant.
- Electroconvulsive therapy or transcranial magnetic stimulation within 6 months prior of screening.
- ECG or clinical evidence of atrial or ventricular hypertrophy.
Trial locations and contacts
45 sites in 1 country.
45 sites in 1 country
United States45 sites
GSK Investigational Site
Austin, Texas, 78756
GSK Investigational Site
Bellaire, Texas, 77401
GSK Investigational Site
Beverly Hills, California, 90210
GSK Investigational Site
Braintree, Massachusetts, 02184
GSK Investigational Site
Brooklyn, New York, 11235
GSK Investigational Site
Burbank, California, 91506
GSK Investigational Site
Charleston, South Carolina, 29407
GSK Investigational Site
Charlotte, North Carolina, 28209
GSK Investigational Site
Charlottesville, Virginia, 22908
GSK Investigational Site
Cleveland, Ohio, 44109
GSK Investigational Site
Columbia, South Carolina, 29201
GSK Investigational Site
Coral Springs, Florida, 33065
GSK Investigational Site
Denver, Colorado, 80212
GSK Investigational Site
Eugene, Oregon, 97401
GSK Investigational Site
Fort Worth, Texas, 76107
GSK Investigational Site
Greenfield, Massachusetts, 01301
GSK Investigational Site
Indianapolis, Indiana, 46202
GSK Investigational Site
Jacksonville, Florida, 32216
GSK Investigational Site
La Mesa, California, 91942
GSK Investigational Site
Las Vegas, Nevada, 89146
GSK Investigational Site
Lincoln, Rhode Island, 02865-4208
GSK Investigational Site
Little Rock, Arkansas, 72223
GSK Investigational Site
Marietta, Georgia, 30060
GSK Investigational Site
Mesa, Arizona, 85210
GSK Investigational Site
Middleton, Wisconsin, 53562-2215
GSK Investigational Site
Minneapolis, Minnesota, 55454
GSK Investigational Site
New Orleans, Louisiana, 70112
GSK Investigational Site
New York, New York, 10128
GSK Investigational Site
Oak Brook, Illinois, 60523
GSK Investigational Site
Oklahoma City, Oklahoma, 73112
GSK Investigational Site
Oklahoma City, Oklahoma, 73117
GSK Investigational Site
Orlando, Florida, 32806
GSK Investigational Site
Phoenix, Arizona, 85023
GSK Investigational Site
Portland, Oregon, 97209
GSK Investigational Site
Portland, Oregon, 97210
GSK Investigational Site
Rockville, Maryland, 20852
GSK Investigational Site
San Antonio, Texas, 78229
GSK Investigational Site
San Francisco, California, 94109
GSK Investigational Site
Scottsdale, Arizona, 85251
GSK Investigational Site
Smyrna, Georgia, 30080
GSK Investigational Site
Temecula, California, 92591
GSK Investigational Site
Toledo, Ohio, 43623
GSK Investigational Site
Upland, California, 91786
GSK Investigational Site
Walnut Creek, California, 94598
GSK Investigational Site
Yakima, Washington, 98902
About this study
Official title: A Twelve-week, Multi-center, Randomized, Double-blind, Double-dummy, Parallel-group, Active Controlled, Escalating Dose Study to Compare the Effects on Sexual Functioning of Bupropion Hydrochloride Extended-release (WELLBUTRIN XL, 150-450 mg/Day) and Extended-release Venlafaxine (EFFEXOR XR, 75-225 mg/Day) in Subjects With Major Depressive Disorder
Effects of two depression medication on sexual functioning
Read the detailed description
A Twelve-week, Multi-center, Randomized, Double-blind, Double-dummy, Parallel-group, Active controlled, Escalating Dose Study to Compare the Effects on Sexual Functioning of Bupropion Hydrochloride Extended-release (WELLBUTRIN XL, 150-450 mg/day) and Extended-release Venlafaxine (EFFEXOR XR, 75-225 mg/day) in Subjects with Major Depressive Disorder
- Being tested
- Bupropion Hydrochloride Extended-release, Extended-release Venlafaxine
- Keywords
- sexual dysfunction, Depression, MDD
- Medical subject headings
- Depressive Disorder, Major, Sexual Dysfunction, Physiological, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupropion Hydrochloride Extended-releaseDrug
Extended-release VenlafaxineDrug
Also called Bupropion Hydrochloride Extended-release
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the effects of bupropion XL and venlafaxine XR on overall sexual functioning in outpatients with MDD as measured by mean changes in CSFQ-S total scores across Weeks 5, 6, 9 and 12.
Secondary outcomes (1)
Efficacy, Safety, Tolerability, Health Outcome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2006 (estimated)
- Study startSep 2004
- Primary completionMay 2005
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 347 participants
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00316160
- Sponsor's protocol ID
- 100368
- Status last verified
- May 2017
- First submitted
- 18 Apr 2006
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Thase ME, Clayton AH, Haight BR, Thompson AH, Modell JG, Johnston JA. A double-blind comparison between bupropion XL and venlafaxine XR: sexual functioning, antidepressant efficacy, and tolerability. J Clin Psychopharmacol. 2006 Oct;26(5):482-8. doi: 10.1097/01.jcp.0000239790.83707.ab.
PubMed 16974189
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Twelve-week, Multi-center, Randomized, Double-blind, Double-dummy, Parallel-group, Active Controlled, Escalating Dose Study to Compare the Effects on Sexual Functioning of Bupropion Hydrochloride Extended-release (WELLBUTRIN XL, 150-450 mg/Day) and Extended-release Venlafaxine (EFFEXOR XR, 75-225 mg/Day) in Subjects With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT00316160
- Acronym / sponsor ID
- 100368
- Keywords
- sexual dysfunction, Depression, MDD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 347 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Primary completion
- May 2005 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 20 Apr 2006 (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.
Effects of two depression medication on sexual functioning
Detailed description
A Twelve-week, Multi-center, Randomized, Double-blind, Double-dummy, Parallel-group, Active controlled, Escalating Dose Study to Compare the Effects on Sexual Functioning of Bupropion Hydrochloride Extended-release (WELLBUTRIN XL, 150-450 mg/day) and Extended-release Venlafaxine (EFFEXOR XR, 75-225 mg/day) 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 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Primary diagnosis of Major Depressive Disorder (MDD)
- must have met DSM-IV criteria for current major depressive episode for at least 8 weeks but no long than 2 years.
- HAM-D17 total score of >17 at screening and baseline.
- Severity of illness score of >4 at screening and baseline.
- Willing to discuss sexual functioning with investigator or designee.
Key exclusion criteria (10 listed)
- Past or current DSM-IV diagnosis of Bipolar Disorder I or II, schizophrenia or another psychotic disorder(s).
- Primary DSM-IV diagnosis or received treatment for Panic Disorder, Obsessive Compulsive Disorder or Post Stress Disorder within previous 12 months.
- Poses a homicidal or serious suicidal risk, have made an attempt within months prior to screening or who has ever been homicidal.
- Myocardial infarction with 1 year of screening.
- Taken ibupropion hydrochloride or venlafaxine in the last 6 months.
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 |
|---|---|---|
| Bupropion Hydrochloride Extended-release | Drug | – |
| Extended-release VenlafaxineAlso: Bupropion Hydrochloride Extended-release | Drug | – |
Primary outcome
To compare the effects of bupropion XL and venlafaxine XR on overall sexual functioning in outpatients with MDD as measured by mean changes in CSFQ-S total scores across Weeks 5, 6, 9 and 12.
1 secondary outcome
Efficacy, Safety, Tolerability, Health Outcome
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 30 May 2017.
- Results publication: PubMed 16974189Thase ME, Clayton AH, Haight BR, Thompson AH, Modell JG, Johnston JA. A double-blind comparison between bupropion XL and venlafaxine XR: sexual functioning, antidepressant efficacy, and tolerability. J Clin Psychopharmacol. 2006 Oct;26(5):482-8. doi: 10.1097/01.jcp.0000239790.83707.ab.
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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
45 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 Bupropion Hydrochloride Extended-release and Extended-release Venlafaxine in people with Depressive Disorder, Major and Major Depressive Disorder (MDD), run by GlaxoSmithKline at 45 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 6 inclusion and 10 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 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 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 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?
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?
To compare the effects of bupropion XL and venlafaxine XR on overall sexual functioning in outpatients with MDD as measured by mean changes in CSFQ-S total scores across Weeks 5, 6, 9 and 12.. 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 NCT00316160, which also lists 1 linked publication.
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 30 May 2017; AzTrials last refreshed its copy on 26 Oct 2026.