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Completed

NCT Number: NCT00439868

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Gainesville, Florida, 32605, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

WellbutrinXL

Drug

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

Placebo

Drug

Matching placebo tablets to WELLBUTRIN XL.

Other names: WellbutrinXL

Primary outcomes

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

    Time frame: at Day -1, Days 1 & 14.

Secondary outcomes

  1. Intraocular pressure,Pupil diameter, anterior chamber angle

    Time frame: Days-1,1&14

  2. Wellbutrin XL plasma level

    Time frame: Days1,12-14

  3. adverse events

    Time frame: each visit

  4. lab tests,ECG,vital signs:

    Time frame: screening,followup

  5. lab tests:

    Time frame: Days-2,13-14

  6. ECG:

    Time frame: Day 14

  7. vital signs:

    Time frame: Days-2,-1,1,14

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Feb 26, 2007
Registry last updated
Aug 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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