A Study To Evaluate The Effect Of WELLBUTRIN XL On Intraocular Pressure

Condition(s) targeted: Healthy

Intervention: WellbutrinXL (Drug); placebo (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

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.

Official title: A Cross-Over Study to Evaluate the Effect of WELLBUTRIN XL on Intraocular Pressure in Healthy Volunteers

Study design: Diagnostic, Non-Randomized, Double-Blind, Placebo Control, Crossover Assignment

Primary outcome: Intraocular pressure at Day -1, Days 1 & 14.

Secondary outcome:

Intraocular pressure,Pupil diameter, anterior chamber angle

Wellbutrin XL plasma level

adverse events

lab tests,ECG,vital signs:

lab tests:

ECG:

vital signs:

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

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.

GSK Clinical Trials Call Center, Gainesville, Florida 32605, United States

Starting date: February 2007
Last updated: September 13, 2007