A Trial of Wellbutrin for Crohn's Disease

NCT ID: NCT00126373

Last Updated: 2012-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2006-03-31

Brief Summary

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

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).

Conditions

Crohn Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Sugar pill

Placebo (sugar) pill with identical look to bupropion

Group Type: PLACEBO_COMPARATOR

Wellbutrin (bupropion)

Intervention Type: DRUG

bupropion 150mg-300mg daily

buproprion

bupropion pill

Group Type: EXPERIMENTAL

Wellbutrin (bupropion)

Intervention Type: DRUG

bupropion 150mg-300mg daily

Interventions

Wellbutrin (bupropion)

bupropion 150mg-300mg daily

Intervention Type: DRUG

Other Intervention Names

Wellbutrin, bupropion

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Altschuler, Eric, M.D.

INDIV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric L Altschuler, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Mt. Sinai Medical Center

Locations

University of Chicago

Chicago, Illinois, United States

Mt. Sinai Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

CGO10410022

Identifier Type: -

Identifier Source: org_study_id