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

Study Overview
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Brief Summary
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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.

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

Conditions
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Depressive Disorder

Intervention / Treatment
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* Drug: WellbutrinXL
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Crossover Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group 1<br>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<br>* WELLBUTRIN XL tablets will be available with dose strength of 150 and 300 mg.<br>Drug: placebo<br>* Matching placebo tablets to WELLBUTRIN XL.<br>* Other names: WellbutrinXL;|
| Experimental: Treatment Group 2<br>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<br>* WELLBUTRIN XL tablets will be available with dose strength of 150 and 300 mg.<br>Drug: placebo<br>* Matching placebo tablets to WELLBUTRIN XL.<br>* Other names: WellbutrinXL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure at Day -1, Days 1 & 14. |  | at Day -1, Days 1 & 14. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| ECG: |  | Day 14 | 
| vital signs: |  | Days-2,-1,1,14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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WELLBUTRIN XL, intraocular pressure, healthy volunteers