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A Trial of Wellbutrin for Crohn's Disease
This study has been completed.
First Received: August 2, 2005   Last Updated: March 17, 2006   History of Changes
Sponsor: Altschuler, Eric, M.D.
Collaborator: GlaxoSmithKline
Information provided by: Altschuler, Eric, M.D.
ClinicalTrials.gov Identifier: NCT00126373
  Purpose

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


Condition Intervention Phase
Crohn Disease
Drug: Wellbutrin (bupropion)
Phase II
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title: A Randomized Controlled Trial of Wellbutrin for Crohn's Disease

Resource links provided by NLM:


Further study details as provided by Altschuler, Eric, M.D.:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 80
Study Start Date: May 2005
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00126373

Locations
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, New York
Mt. Sinai Medical Center
New York, New York, United States, 10029
Sponsors and Collaborators
Altschuler, Eric, M.D.
GlaxoSmithKline
Investigators
Principal Investigator: Eric L Altschuler, M.D., Ph.D. Mt. Sinai Medical Center
  More Information

No publications provided

Study ID Numbers: CGO10410022
Study First Received: August 2, 2005
Last Updated: March 17, 2006
ClinicalTrials.gov Identifier: NCT00126373     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Altschuler, Eric, M.D.:
Crohn disease
TNF-alpha

Additional relevant MeSH terms:
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Ileitis
Gastrointestinal Diseases
Enteritis
Physiological Effects of Drugs
Psychotropic Drugs
Inflammatory Bowel Diseases
Intestinal Diseases
Ileal Diseases
Pharmacologic Actions
Digestive System Diseases
Therapeutic Uses
Crohn Disease
Bupropion
Dopamine Agents
Gastroenteritis
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on November 05, 2009