Overview
A Study To Evaluate The Effect Of WELLBUTRIN XL On Intraocular Pressure
Status:
Completed
Completed
Trial end date:
2007-06-08
2007-06-08
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
GlaxoSmithKlineTreatments:
Bupropion
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.