Status:
COMPLETED
A Study To Evaluate The Effect Of WELLBUTRIN XL On Intraocular Pressure
Lead Sponsor:
GlaxoSmithKline
Conditions:
Depressive Disorder
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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.
Eligibility Criteria
Inclusion
- Healthy males or females.
- Non-smokers
- Agree to remain in the clinic for the time defined in the protocol.
- Normal ECG.
Exclusion
- 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.
Key Trial Info
Start Date :
February 16 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 8 2007
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00439868
Start Date
February 16 2007
End Date
June 8 2007
Last Update
August 10 2017
Active Locations (1)
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1
GSK Investigational Site
Gainesville, Florida, United States, 32605