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Completed

NCT Number: NCT01981889

Steroid-induced Mood Changes in Patients With Inflammatory Bowel Disease

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pacific Gastroenterology Associates

Vancouver, British Columbia, V6Z 2K5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prednisone

Drug

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 names: Prednisone 40 mg

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Nov 13, 2013
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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