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

This study has been completed.

First Received on February 22, 2007. Last Updated on March 17, 2011 History of Changes

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00439868

Purpose

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.

Condition	Intervention	Phase
Healthy Subjects Depressive Disorder	Drug: WellbutrinXL Drug: placebo	Phase I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Diagnostic
Official Title:	A Cross-over Study to Evaluate the Effect of WELLBUTRIN XL on Intraocular Pressure in Healthy Volunteers

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Bupropion hydrochloride Bupropion

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Intraocular pressure at Day -1, Days 1 & 14. [ Time Frame: at Day -1, Days 1 & 14. ]

Secondary Outcome Measures:

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

Enrollment:	33
Study Start Date:	February 2007

Intervention Details:

Other Names:

placebo
WellbutrinXL

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00439868

Locations

United States, Florida
GSK Investigational Site
Gainesville, Florida, United States, 32605

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00439868 History of Changes
Other Study ID Numbers:	WXL108709
Study First Received:	February 22, 2007
Last Updated:	March 17, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

WELLBUTRIN XL, intraocular pressure, healthy volunteers

Additional relevant MeSH terms:

Depressive Disorder
Depression
Mood Disorders
Mental Disorders
Behavioral Symptoms
Bupropion
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012