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

Phase 1

Completed

• Conditions: Depressive Disorder
• Interventions: Drug: WellbutrinXL; Drug: placebo

• Registration Number: NCT00439868
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02-16
• Study First Submitted: 2007-02-22
• Study First Submitted QC: 2007-02-22
• Study First Posted: 2007-02-26
• Primary Completion: 2007-06-08
• Study Completion: 2007-06-08
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-09
• Last Update Posted: 2017-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• Healthy males or females.
• Non-smokers
• Agree to remain in the clinic for the time defined in the protocol.
• Normal ECG.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment Group 2	WellbutrinXL	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 Group 2	placebo	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 Group 1	WellbutrinXL	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 Group 1	placebo	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.

Primary Outcome Measures

Name	Time	Method
Intraocular pressure at Day -1, Days 1 & 14.	at Day -1, Days 1 & 14.

Secondary Outcome Measures

Name	Time	Method
adverse events	each visit
lab tests,ECG,vital signs:	screening,followup
lab tests:	Days-2,13-14
ECG:	Day 14
vital signs:	Days-2,-1,1,14
Intraocular pressure,Pupil diameter, anterior chamber angle	Days-1,1&14
Wellbutrin XL plasma level	Days1,12-14

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Gainesville, Florida, United States