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

NCT00439868 | Completed Phase 1

• 1 other identifier: WXL108709
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Disorder

Keywords

WELLBUTRIN XL, intraocular pressure, healthy volunteers

Outcome Measures

Primary Outcomes (1)

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

  at Day -1, Days 1 & 14.

Secondary Outcomes (7)

• 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

Study Arms (2)

Treatment Group 1

EXPERIMENTAL

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.

Drug: WellbutrinXL; Drug: placebo

Treatment Group 2

EXPERIMENTAL

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.

Drug: WellbutrinXL; Drug: placebo

Interventions

WellbutrinXL DRUG

WELLBUTRIN XL tablets will be available with dose strength of 150 and 300 mg.

Treatment Group 1; Treatment Group 2

placebo DRUG

Matching placebo tablets to WELLBUTRIN XL.

Also known as: WellbutrinXL

Treatment Group 1; Treatment Group 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males or females.
• Non-smokers
• Agree to remain in the clinic for the time defined in the protocol.
• Normal ECG.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Gainesville, Florida, 32605, United States

Location

Related Links

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

MeSH Terms

Conditions

Depressive Disorder

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2007
• First Posted: February 26, 2007
• Study Start: February 16, 2007
• Primary Completion: June 8, 2007
• Study Completion: June 8, 2007
• Last Updated: August 10, 2017

Record last verified: 2017-08

Locations

US (1)