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

NCT ID: NCT00439868

Last Updated: 2017-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-16
• Study Completion Date: 2007-06-08

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.

Conditions

Depressive Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC

Study Groups

Treatment Group 1

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.

Group Type: EXPERIMENTAL

WellbutrinXL

Intervention Type: DRUG

WELLBUTRIN XL tablets will be available with dose strength of 150 and 300 mg.

placebo

Intervention Type: DRUG

Matching placebo tablets to WELLBUTRIN XL.

Treatment Group 2

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.

Group Type: EXPERIMENTAL

WellbutrinXL

Intervention Type: DRUG

WELLBUTRIN XL tablets will be available with dose strength of 150 and 300 mg.

placebo

Intervention Type: DRUG

Matching placebo tablets to WELLBUTRIN XL.

Interventions

WellbutrinXL

WELLBUTRIN XL tablets will be available with dose strength of 150 and 300 mg.

Intervention Type: DRUG

placebo

Matching placebo tablets to WELLBUTRIN XL.

Intervention Type: DRUG

Other Intervention Names

WellbutrinXL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Gainesville, Florida, United States

Countries

United States

Other Identifiers

WXL108709

Identifier Type: -

Identifier Source: org_study_id