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

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ClinicalTrials.gov Identifier: NCT00439868
Recruitment Status : Completed
First Posted : February 26, 2007
Last Update Posted : August 10, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.

Condition or disease Intervention/treatment Phase
Depressive Disorder Drug: WellbutrinXL Drug: placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Primary Purpose: Diagnostic
Official Title: A Cross-over Study to Evaluate the Effect of WELLBUTRIN XL on Intraocular Pressure in Healthy Volunteers
Actual Study Start Date : February 16, 2007
Actual Primary Completion Date : June 8, 2007
Actual Study Completion Date : June 8, 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment Group 1
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
WELLBUTRIN XL tablets will be available with dose strength of 150 and 300 mg.

Drug: placebo
Matching placebo tablets to WELLBUTRIN XL.
Other Name: WellbutrinXL

Experimental: Treatment Group 2
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
WELLBUTRIN XL tablets will be available with dose strength of 150 and 300 mg.

Drug: placebo
Matching placebo tablets to WELLBUTRIN XL.
Other Name: WellbutrinXL




Primary Outcome Measures :
  1. Intraocular pressure at Day -1, Days 1 & 14. [ Time Frame: at Day -1, Days 1 & 14. ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00439868


Locations
United States, Florida
GSK Investigational Site
Gainesville, Florida, United States, 32605
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00439868     History of Changes
Other Study ID Numbers: WXL108709
First Posted: February 26, 2007    Key Record Dates
Last Update Posted: August 10, 2017
Last Verified: August 2017

Keywords provided by GlaxoSmithKline:
WELLBUTRIN XL, intraocular pressure, healthy volunteers

Additional relevant MeSH terms:
Depressive Disorder
Depression
Mood Disorders
Mental Disorders
Behavioral Symptoms
Bupropion
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors