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

Official Title: “A Cross-over Study to Evaluate the Effect of WELLBUTRIN XL on Intraocular Pressure in Healthy Volunteers”

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.

Intervention(s) in this Clinical Trial

• Drug: WellbutrinXL
• Drug: placebo

Primary Measures

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

Secondary 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
    

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: GlaxoSmithKline Industry

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials, MD Study Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00439868

Study ID Number: WXL108709

ClinicalTrials.gov Identifier: NCT00439868

Health Authority: United States: Food and Drug Administration