Depressive DisorderPhase 1NCT00439868
A Study To Evaluate The Effect Of WELLBUTRIN XL On Intraocular Pressure
A Phase 1 study testing WellbutrinXL in people with Depressive Disorder, run by GlaxoSmithKline at 1 site in United States.
Trial summary
This study will be conducted in healthy volunteers to investigate the effect on intraocular pressure of 2 weeks of treatment with 300mg WELLBUTRIN XL/day. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Depressive Disorder
- What is being tested?
- WellbutrinXL
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2007to 8 Jun 2007
- Phase
- Phase 1
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males or females.
- Non-smokers
- Agree to remain in the clinic for the time defined in the protocol.
- Normal ECG.
Who cannot join
- Any serious medical disorder or condition.
- Any history of an endocrine disorder.
- Any clinically significant laboratory abnormality.
- History of psychiatric illness.
- Any history of suicidal attempts or behavior.
- Risk factors for precipitation of angle closure glaucoma or elevated IOP.
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- Inability to refrain from use of contact lenses during the study days, if correction is required.
- Self-administered Beck Depression Inventory II scale total score greater than 9, and a suicide question score of greater than zero.
- Current or past history of seizure disorder or brain injury (traumatic or disease-related); or any condition which, in the opinion of the investigator, predisposes to seizure - Women having a positive serum HCG pregnancy test at screening, a positive urine pregnancy test before admission to the Unit during the in-house periods, who are not willing to use acceptable methods of contraception or who are lactating or planning to become pregnant within the three months following the screening visit.
Trial locations and contacts
1 site in 1 country.
United States1 site
GSK Investigational Site
Gainesville, Florida, 32605
About this study
Official title: A Cross-over Study to Evaluate the Effect of WELLBUTRIN XL on Intraocular Pressure in Healthy Volunteers
This study will be conducted in healthy volunteers to investigate the effect on intraocular pressure of 2 weeks of treatment with 300mg WELLBUTRIN XL/day.
- Conditions
- Depressive Disorder
- Being tested
- WellbutrinXL, placebo
- Keywords
- WELLBUTRIN XL, intraocular pressure, healthy volunteers
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WellbutrinXLDrug
WELLBUTRIN XL tablets will be available with dose strength of 150 and 300 mg.
placeboDrug
Also called WellbutrinXL
Matching placebo tablets to WELLBUTRIN XL.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group 1 | Experimental | Subjects in Period 1 of treatment group 1 will receive oral doses of extended release WELLBUTRIN XL tablets for 2 weeks, from Days 1-3 subject will receive 150 milligram (mg) tablets once daily (QD) and from Days 4-14 300 mg QD. In Period 2 subject will receive placebo for 2 weeks. Receives: Drug: WellbutrinXL; Drug: placebo |
| Treatment Group 2 | Experimental | Subjects in Period 1 of Treatment group 2 will receive Placebo for 2 weeks and in Period 2 subject will receive oral doses of extended release WELLBUTRIN XL for 2 weeks, from Days 1-3 subject will receive 150 milligram (mg) tablets once daily (QD) and from Days 4-14 300 mg QD. Receives: Drug: WellbutrinXL; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure at Day -1, Days 1 & 14.
Measured: at Day -1, Days 1 & 14.
Secondary outcomes (7)
Intraocular pressure,Pupil diameter, anterior chamber angle
Measured: Days-1,1&14
Wellbutrin XL plasma level
Measured: Days1,12-14
adverse events
Measured: each visit
lab tests,ECG,vital signs:
Measured: screening,followup
lab tests:
Measured: Days-2,13-14
ECG:
Measured: Day 14
vital signs:
Measured: Days-2,-1,1,14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2007 (estimated)
- Study start16 Feb 2007
- Primary completion8 Jun 2007
- Study completion8 Jun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisorderStudies 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 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Enrolment
- 33 participants (actual)
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
- NCT00439868
- Sponsor's protocol ID
- WXL108709
- Status last verified
- Aug 2017
- First submitted
- 22 Feb 2007
- Last updated
- 10 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-over Study to Evaluate the Effect of WELLBUTRIN XL on Intraocular Pressure in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00439868
- Acronym / sponsor ID
- WXL108709
- Conditions
- Depressive Disorder
- Keywords
- WELLBUTRIN XL, intraocular pressure, healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 16 Feb 2007 (actual)
- Primary completion
- 8 Jun 2007 (actual)
- Study completion
- 8 Jun 2007 (actual)
- First posted
- 26 Feb 2007 (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 study will be conducted in healthy volunteers to investigate the effect on intraocular pressure of 2 weeks of treatment with 300mg WELLBUTRIN XL/day.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group 1 | Experimental | Drug: WellbutrinXL, Drug: placeboSubjects in Period 1 of treatment group 1 will receive oral doses of extended release WELLBUTRIN XL tablets for 2 weeks, from Days 1-3 subject will receive 150 milligram (mg) tablets once daily (QD) and from Days 4-14 300 mg QD. In Period 2 subject will receive placebo for 2 weeks. |
| Treatment Group 2 | Experimental | Drug: WellbutrinXL, Drug: placeboSubjects in Period 1 of Treatment group 2 will receive Placebo for 2 weeks and in Period 2 subject will receive oral doses of extended release WELLBUTRIN XL for 2 weeks, from Days 1-3 subject will receive 150 milligram (mg) tablets once daily (QD) and from Days 4-14 300 mg QD. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy males or females.
- Non-smokers
- Agree to remain in the clinic for the time defined in the protocol.
- Normal ECG.
Key exclusion criteria (9 listed)
- Any serious medical disorder or condition.
- Any history of an endocrine disorder.
- Any clinically significant laboratory abnormality.
- History of psychiatric illness.
- Any history of suicidal attempts or behavior.
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 |
|---|---|---|
| WellbutrinXLWELLBUTRIN XL tablets will be available with dose strength of 150 and 300 mg. | Drug | Treatment Group 1, Treatment Group 2 |
| placeboAlso: WellbutrinXLMatching placebo tablets to WELLBUTRIN XL. | Drug | Treatment Group 1, Treatment Group 2 |
Primary outcome
Intraocular pressure at Day -1, Days 1 & 14.
Time frame: at Day -1, Days 1 & 14.
7 secondary outcomes
Intraocular pressure,Pupil diameter, anterior chamber angle
Time frame: Days-1,1&14
Wellbutrin XL plasma level
Time frame: Days1,12-14
adverse events
Time frame: each visit
lab tests,ECG,vital signs:
Time frame: screening,followup
lab tests:
Time frame: Days-2,13-14
ECG:
Time frame: Day 14
vital signs:
Time frame: Days-2,-1,1,14
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 10 Aug 2017.
- Results for study WXL108709 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing WellbutrinXL in people with Depressive Disorder, run by GlaxoSmithKline at 1 site 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 4 inclusion and 9 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 10 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Intraocular pressure at Day -1, Days 1 & 14. (time frame: at Day -1, Days 1 & 14.). 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 10 Aug 2017.