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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00439868

Enrollment

Registered

2007-02-26

Start date

2007-02-16

Completion date

2007-06-08

Last updated

2017-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Disorder

Keywords

WELLBUTRIN XL, intraocular pressure, healthy volunteers

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.

Interventions

DRUGWellbutrinXL

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

DRUGplacebo

Matching placebo tablets to WELLBUTRIN XL.

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Intraocular pressure at Day -1, Days 1 & 14.	at Day -1, Days 1 & 14.

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026