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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Depressive Disorder

Treatments: Drug: placebo; Drug: WellbutrinXL

Study type: Interventional

Funder types: Industry

Identifiers

NCT00439868

WXL108709

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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 design

33 participants in 2 patient groups

Treatment Group 1

Experimental group

Description:

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.

Treatment:

Drug: WellbutrinXL

Drug: placebo

Treatment Group 2

Experimental group

Description:

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.

Treatment:

Drug: WellbutrinXL

Drug: placebo