A Trial of Wellbutrin for Crohn's Disease

Completed · Phase 2/Phase 3

Conditions studied: Crohn Disease

In brief

The investigators are testing the hypothesis that Wellbutrin (bupropion) can give a clinical remission in Crohn's disease.

Key facts

Study ID

NCT00126373

Run by

Altschuler, Eric, M.D.

People needed

1

Starts

2005-05-01

Expected to finish

2006-03-01

Last updated by the study team

2012-01-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Moderate to severe Crohn's disease with 220 < CDAI < 400.
• All patients in the study must have not had any anti-TNF antibodies for at least eight weeks.

You may not qualify if…

• Patients will be excluded from the study if they have fulminant Crohn's disease requiring parenteral steroid treatment, hospitalization, or need of surgery imminently.
• Patients with serious infections in the preceding three months, opportunistic infections within one month, or current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurological, or cerebral disease will be excluded.
• Patients will also be excluded from the study if they have a history of a seizure, epilepsy, presumed current central nervous system tumor, have or have had anorexia nervosa or bulimia, are currently taking or have taken in the last four weeks any drug in the monoamine oxidase inhibitor class, or are allergic to Wellbutrin.
• Patients with active major depression or suicidal ideation will be excluded, as will patients with a score of 19 or higher on the Beck depression inventory.
• Patients will be excluded if they are currently or have taken a medicine in the selective serotonin reuptake class, mirtazapine, venlafaxine, a tricyclic antidepressant, a mood stabilizing, or antipsychotic medication in the previous two weeks.
• Patients will be excluded if they are currently abusing alcohol or have alcohol dependence.
• Patients will be excluded from the study if their baseline liver function tests are greater than twice the upper limit of normal, or if a clinical investigator believes that their baseline chemistry, liver function tests or complete blood count contraindicates entry into the study.
• Pregnant or lactating females are excluded.

Where it is running

• University of Chicago — Chicago, Illinois, United States
• Mt. Sinai Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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