Back to resultsA Study To Evaluate The Effect Of WELLBUTRIN XL On Intraocular Pressure
Primary Purpose
Depressive Disorder
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
WellbutrinXL
placebo
Sponsored by
About this trial
This is an interventional diagnostic trial for Depressive Disorder focused on measuring WELLBUTRIN XL, intraocular pressure, healthy volunteers
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.
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Treatment Group 1
Treatment Group 2
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Intraocular pressure at Day -1, Days 1 & 14.
Secondary Outcome Measures
Intraocular pressure,Pupil diameter, anterior chamber angle
Wellbutrin XL plasma level
adverse events
lab tests,ECG,vital signs:
lab tests:
ECG:
vital signs:
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00439868
Brief Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
February 16, 2007 (Actual)
Primary Completion Date
June 8, 2007 (Actual)
Study Completion Date
June 8, 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder
Keywords
WELLBUTRIN XL, intraocular pressure, healthy volunteers
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Allocation
Non-Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment Group 2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
WellbutrinXL
Intervention Description
WELLBUTRIN XL tablets will be available with dose strength of 150 and 300 mg.
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
WellbutrinXL
Intervention Description
Matching placebo tablets to WELLBUTRIN XL.
Primary Outcome Measure Information:
Title
Intraocular pressure at Day -1, Days 1 & 14.
Time Frame
at Day -1, Days 1 & 14.
Secondary Outcome Measure Information:
Title
Intraocular pressure,Pupil diameter, anterior chamber angle
Time Frame
Days-1,1&14
Title
Wellbutrin XL plasma level
Time Frame
Days1,12-14
Title
adverse events
Time Frame
each visit
Title
lab tests,ECG,vital signs:
Time Frame
screening,followup
Title
lab tests:
Time Frame
Days-2,13-14
Title
ECG:
Time Frame
Day 14
Title
vital signs:
Time Frame
Days-2,-1,1,14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study To Evaluate The Effect Of WELLBUTRIN XL On Intraocular Pressure
We'll reach out to this number within 24 hrs