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Steroid-induced Mood Changes in Patients With Inflammatory Bowel Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01981889
Recruitment Status : Completed
First Posted : November 13, 2013
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
University of British Columbia

Brief Summary:
Steroid is commonly used to treat autoimmune disorders such as rheumatoid arthritis, lupus, and inflammatory bowel disease (Crohn's Disease and Ulcerative Colitis). However, its use is associated with numerous systemic side-effects, including diabetes, osteoporosis, and potentially significant mood changes. The investigators wish to determine how common patients with inflammatory bowel disease experience mood changes when they take steroid for their disease.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Disease 11 Drug: Prednisone Phase 4

Detailed Description:

Patients who are eligible to participate in the study are invited. Before starting prednisone therapy, the following data are collected: basic demographic data (age, gender), education history, past medical history (particularly IBD history such as age of diagnosis and previous treatments/surgery), current medications/non-prescription drugs will be collected. IBD activity is measured by Harvey-Bradshaw Index for Crohn's Disease and Simple Clinical Colitis Activity Index (SCCAI) for all subjects with Ulcerative Colitis. Subjects are asked to complete self-administered surveys --- Internal State Scale (ISS) for patients to self-report mood states including depressive, manic, or mixed states and Beck Depression Inventory II (BDI-II) for screening depression

Two weeks after starting Prednisone 40 mg/day and at the end of steroid taper, IBD activity will be measured by Harvey-Bradshaw Index for Crohn's Disease and Simple Clinical Colitis Activity Index (SCCAI) for all subjects with Ulcerative Colitis. Self-administered surveys --- Internal State Scale (ISS) and Beck Depression Inventory II (BDI-II) are completed.

It is possible that a new diagnosis of an underlying psychiatric disorder may be discovered as a result of participating in this study. In the event that an underlying psychiatric disorder is suspected based on the results of the questionnaires on the first visit (BDI-II ≥21 moderate depression or ISS Activation scale ≥ 155), the patient would be offered the option for an expedited formal psychiatric referral. This will not exclude them from the study unless therapy is deemed necessary by the consulting psychiatrist.

Should patients develop significant mood changes impairing daily/social functioning during the study as a result of steroid therapy, they will be assessed urgently by attending gastroenterologist and if necessary, in consultation with a psychiatrist to determine the best course of action, which may include cessation of steroid therapy or addition of psychiatric therapy. Otherwise, less significant mood changes will be monitored closely as these may be expected to resolve upon discontinuation of steroid therapy.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Steroid-induced Mood Changes in Patients With Inflammatory Bowel Disease
Study Start Date : October 2013
Actual Primary Completion Date : May 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids
Drug Information available for: Prednisone

Arm Intervention/treatment
Participants who are started on Prednisone 40 mg per day for 2 weeks and then tapered.
Drug: Prednisone
Participants will be started on oral prednisone 40mg/day for two weeks as per standard of practice in IBD management, before starting a tapering course.
Other Name: Prednisone 40 mg

Primary Outcome Measures :
  1. Determination of steroid-induced mood changes. [ Time Frame: Participants will be followed up until they taper their steroid dose, average of 6 weeks ]
    Incidence rate of steroid-induced mood changes (as defined by BDI-II score increase by 10 points, or manic/hypomanic symptoms with ISS activation score increase by 50 points) will be determined. The score from validated scales will be analyzed using t-test to determine if there is any statistically significant change from baseline after institution of steroid treatment. Total scores as well as modified scale scores (after removing gastrointestinal symptoms that may be influenced by IBD activities) will be compared. Descriptive analyses will also be performed.

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Outpatients with active Ulcerative Colitis or Crohn's Disease being initiated on oral prednisone for treatment of their IBD.
  • Age 19 or greater
  • Must be able to read and understand English
  • Must be capable of providing informed written consent

Exclusion Criteria:

  • Hospitalization within 2 weeks of study entry
  • Liver cirrhosis with or without evidence of synthetic liver dysfunction
  • Medications that interfere with corticosteroid metabolism (Clarithromycin, cyclosporine, imatinib, ketoconazole, and nefazodone)
  • Psychiatric medication changes within 1 month of study entry
  • Recreational drug use (due to their potential to alter mood) and/or alcohol abuse.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01981889

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Canada, British Columbia
Pacific Gastroenterology Associates
Vancouver, British Columbia, Canada, V6Z 2K5
Sponsors and Collaborators
University of British Columbia
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Principal Investigator: Greg Rosenfeld, MD University of British Columbia

Publications of Results:
Other Publications:

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Responsible Party: University of British Columbia Identifier: NCT01981889     History of Changes
Other Study ID Numbers: H13-02183
First Posted: November 13, 2013    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: October 2016

Keywords provided by University of British Columbia:
steroid, inflammatory bowel diseases

Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents