Steroid-induced Mood Changes in Patients With Inflammatory Bowel Disease

Phase 4

Completed

• Conditions: Inflammatory Bowel Disease 11
• Interventions: Drug: Prednisone

• Registration Number: NCT01981889
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-22
• Study First Submitted QC: 2013-11-05
• Study First Posted: 2013-11-13
• Primary Completion: 2016-05
• Study Completion: 2016-08
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-31
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prednisone	Prednisone	Participants who are started on Prednisone 40 mg per day for 2 weeks and then tapered.

Primary Outcome Measures

Name	Time	Method
Determination of steroid-induced mood changes.	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.

Trial Locations

Locations (1)

Pacific Gastroenterology Associates; 🇨🇦 Vancouver, British Columbia, Canada