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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00439868
First received: February 22, 2007
Last updated: May 31, 2012
Last verified: March 2011
History of Changes

February 22, 2007
May 31, 2012
February 2007
Not Provided
Intraocular pressure at Day -1, Days 1 & 14. [ Time Frame: at Day -1, Days 1 & 14. ]
Intraocular pressure at Day -1, Days 1 & 14.
Complete list of historical versions of study NCT00439868 on ClinicalTrials.gov Archive Site
  • 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 ]
Intraocular pressure,Pupil diameter, anterior chamber angle:Days-1,1&14 Wellbutrin XL plasma level:Days1,12-14 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
Not Provided
Not Provided
 
A Study To Evaluate The Effect Of WELLBUTRIN XL On Intraocular Pressure
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Diagnostic
  • Healthy Subjects
  • Depressive Disorder
  • Drug: WellbutrinXL
  • Drug: placebo
    Other Names:
    • placebo
    • WellbutrinXL
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
Not Provided
Not Provided

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.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00439868
WXL108709
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP