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WellbutrinXL

Phase 1

Depressive Disorder | Small molecule | Psychiatry |GSK plc|Last Updated: Aug 10, 2017

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment33

FDA Designations

No designations recorded

Clinical trial landscape

WellbutrinXL · 1 trial · 1 indication

Phase 1 1
NCT00439868A Study To Evaluate The Effect Of WELLBUTRIN XL On Intraocular PressureDepressive Disorder
COMPLETED33 Analytics
PHASE1COMPLETED
A Study To Evaluate The Effect Of WELLBUTRIN XL On Intraocular Pressure
Depressive DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Secondary Endpoints

Intraocular pressure,Pupil diameter, anterior chamber angle
Days-1,1&14
Wellbutrin XL plasma level
Days1,12-14
adverse events
each visit
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Study Design & Arms

AllocationNON_RANDOMIZED
ModelCROSSOVER
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
Treatment Group 1EXPERIMENTALSubjects 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.
Treatment Group 2EXPERIMENTALSubjects 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.

Interventions

NameTypeDescription
WellbutrinXLDRUGWELLBUTRIN XL tablets will be available with dose strength of 150 and 300 mg.
placeboDRUGMatching placebo tablets to WELLBUTRIN XL.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 abnorm...

Countries:United States
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Frequently asked questions about WellbutrinXL

What is Wellbutrin XL used for?

Wellbutrin XL is a small molecule drug being studied for Orgasmic Disorder and Depressive Disorder. It is developed by GSK plc. The drug is currently in Phase 2 clinical development for these conditions.

Who makes Wellbutrin XL?

Wellbutrin XL is developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The drug is being investigated for use in Orgasmic Disorder and Depressive Disorder.

What phase is Wellbutrin XL in?

Wellbutrin XL is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are ongoing to evaluate its safety and efficacy for the studied indications.

What clinical trials is Wellbutrin XL in?

Wellbutrin XL has been studied in clinical trials including NCT00248209, a Phase 2 trial for Female Orgasmic Disorder, and NCT00439868, a Phase 1 trial for Depressive Disorder. Both trials were completed in the United States.

Is Wellbutrin XL the same as bupropion?

Wellbutrin XL is a brand name for the drug bupropion, which is used to treat depression. However, the specific formulation and delivery mechanism of Wellbutrin XL may differ from other bupropion products.