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

Depressive Disorder Clinical Trial

Official title:

A Cross-over Study to Evaluate the Effect of WELLBUTRIN XL on Intraocular Pressure in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00439868
• Other study ID #: WXL108709
• Status: Completed
• Phase: Phase 1
• First received: February 22, 2007
• Last updated: August 9, 2017
• Start date: February 16, 2007
• Est. completion date: June 8, 2007

Study information

• Verified date: August 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: June 8, 2007
• Est. primary completion date: June 8, 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Drug:
• WellbutrinXL
WELLBUTRIN XL tablets will be available with dose strength of 150 and 300 mg.
• placebo
Matching placebo tablets to WELLBUTRIN XL.

Locations

Country	Name	City	State
United States	GSK Investigational Site	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular pressure at Day -1, Days 1 & 14.		at Day -1, Days 1 & 14.
Secondary	Intraocular pressure,Pupil diameter, anterior chamber angle		Days-1,1&14
Secondary	Wellbutrin XL plasma level		Days1,12-14
Secondary	adverse events		each visit
Secondary	lab tests,ECG,vital signs:		screening,followup
Secondary	lab tests:		Days-2,13-14
Secondary	ECG:		Day 14
Secondary	vital signs:		Days-2,-1,1,14

External Links

•   Results for study WXL108709 can be found on the GSK Clinical Study Register.