Last updated: 11/04/2018 13:48:52
A Study To Evaluate The Effect Of WELLBUTRIN XL On Intraocular Pressure
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A cross-over study to evaluate the effect of WELLBUTRIN XL on intraocular pressure in healthy volunteers
Trial description: 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.
Primary purpose:
Diagnostic
Trial design:
Crossover Assignment
Masking:
Not applicable
Allocation:
Non-randomized
Primary outcomes:
Intraocular pressure at Day -1, Days 1 & 14.
Timeframe: at Day -1, Days 1 & 14.
Secondary outcomes:
Intraocular pressure,Pupil diameter, anterior chamber angle
Timeframe: Days-1,1&14
Wellbutrin XL plasma level
Timeframe: Days1,12-14
adverse events
Timeframe: each visit
lab tests,ECG,vital signs:
Timeframe: screening,followup
lab tests:
Timeframe: Days-2,13-14
ECG:
Timeframe: Day 14
vital signs:
Timeframe: Days-2,-1,1,14
Interventions:
Drug: WellbutrinXL
Drug: placebo
Enrollment:
33
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Depressive Disorder
Product
bupropion
Collaborators
Not applicable
Study date(s)
February 2007 to June 2007
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 55 years
Accepts healthy volunteers
Yes
- Healthy males or females.
- Non-smokers
- Any serious medical disorder or condition.
- Any history of an endocrine disorder.
Inclusion and exclusion criteria
Inclusion criteria:
- Healthy males or females.
- Non-smokers
- Agree to remain in the clinic for the time defined in the protocol.
- Normal ECG.
Exclusion criteria:
- 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.
- 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 location(s)
Location
GSK Investigational Site
Gainesville, Florida, United States, 32605
Status
Terminated/Withdrawn
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-08-06
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Participate in clinical trial
Additional information
Results for study WXL108709 can be found on the GSK Clinical Study Register.
Click hereAccess to clinical trial data by researchers
Visit website