A Trial of Wellbutrin for Crohn's Disease

Condition(s) targeted: Crohn Disease

Intervention: Wellbutrin (bupropion) (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Altschuler, Eric, M.D.

Official(s) and/or principal investigator(s):
Eric L Altschuler, M.D., Ph.D., Principal Investigator, Affiliation: Mt. Sinai Medical Center

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

Official title: A Randomized Controlled Trial of Wellbutrin for Crohn's Disease

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Number of patients with Crohn's disease activity index (CDAI) < 150 at the end of twelve weeks

Secondary outcome:

Number of patients with CDAI drop of at least 70 points at the end of twelve weeks

Time course of CDAI

Effect of drug and/or placebo on tumor necrosis factor-alpha (TNF) levels

Detailed description: Wellbutrin (bupropion) is approved for use as an antidepressant. There have been some cases in which people on Wellbutrin had significant improvement clinically in their Crohn's disease. In this trial, the hypothesis that Wellbutrin can induce clinical remission in Crohn's disease will be tested. The investigators will also be looking to see if Wellbutrin can lower levels of the inflammatory cytokine tumor necrosis factor-alpha (TNF).

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

University of Chicago, Chicago, Illinois 60637, United States

Mt. Sinai Medical Center, New York, New York 10029, United States

Starting date: May 2005
Last updated: March 17, 2006