Steroid-induced Mood Changes in Patients With Inflammatory Bowel Disease

NCT01981889 | Completed Phase 4

• 1 other identifier: H13-02183
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Disease 11

Keywords

steroid, inflammatory bowel diseases

Outcome Measures

Primary Outcomes (1)

• Determination of steroid-induced mood changes.

  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.

  Participants will be followed up until they taper their steroid dose, average of 6 weeks

Study Arms (1)

Prednisone

OTHER

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

Drug: Prednisone

Interventions

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.

Also known as: Prednisone 40 mg

Prednisone

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Pacific Gastroenterology Associates

Vancouver, British Columbia, V6Z 2K5, Canada

Location

Related Publications (14)

• Acute adverse reactions to prednisone in relation to dosage. Clin Pharmacol Ther. 1972 Sep-Oct;13(5):694-8. doi: 10.1002/cpt1972135part1694. No abstract available.

  PMID: 5053810 BACKGROUND

• Olsen EA, Carson SC, Turney EA. Systemic steroids with or without 2% topical minoxidil in the treatment of alopecia areata. Arch Dermatol. 1992 Nov;128(11):1467-73.

  PMID: 1444500 BACKGROUND

• Kornbluth A, Sachar DB; Practice Parameters Committee of the American College of Gastroenterology. Ulcerative colitis practice guidelines in adults: American College Of Gastroenterology, Practice Parameters Committee. Am J Gastroenterol. 2010 Mar;105(3):501-23; quiz 524. doi: 10.1038/ajg.2009.727. Epub 2010 Jan 12.

  PMID: 20068560 BACKGROUND

• Lewis DA, Smith RE. Steroid-induced psychiatric syndromes. A report of 14 cases and a review of the literature. J Affect Disord. 1983 Nov;5(4):319-32. doi: 10.1016/0165-0327(83)90022-8.

  PMID: 6319464 BACKGROUND

• Fardet L, Flahault A, Kettaneh A, Tiev KP, Genereau T, Toledano C, Lebbe C, Cabane J. Corticosteroid-induced clinical adverse events: frequency, risk factors and patient's opinion. Br J Dermatol. 2007 Jul;157(1):142-8. doi: 10.1111/j.1365-2133.2007.07950.x. Epub 2007 May 14.

  PMID: 17501951 BACKGROUND

• Naber D, Sand P, Heigl B. Psychopathological and neuropsychological effects of 8-days' corticosteroid treatment. A prospective study. Psychoneuroendocrinology. 1996 Jan;21(1):25-31. doi: 10.1016/0306-4530(95)00031-3.

  PMID: 8778901 BACKGROUND

• Brown ES, Suppes T, Khan DA, Carmody TJ 3rd. Mood changes during prednisone bursts in outpatients with asthma. J Clin Psychopharmacol. 2002 Feb;22(1):55-61. doi: 10.1097/00004714-200202000-00009.

  PMID: 11799343 BACKGROUND

• Bolanos SH, Khan DA, Hanczyc M, Bauer MS, Dhanani N, Brown ES. Assessment of mood states in patients receiving long-term corticosteroid therapy and in controls with patient-rated and clinician-rated scales. Ann Allergy Asthma Immunol. 2004 May;92(5):500-5. doi: 10.1016/S1081-1206(10)61756-5.

  PMID: 15191017 BACKGROUND

• Beck AT, Steer RA, Ball R, Ranieri W. Comparison of Beck Depression Inventories -IA and -II in psychiatric outpatients. J Pers Assess. 1996 Dec;67(3):588-97. doi: 10.1207/s15327752jpa6703_13.

  PMID: 8991972 BACKGROUND

• Bauer MS, Vojta C, Kinosian B, Altshuler L, Glick H. The Internal State Scale: replication of its discriminating abilities in a multisite, public sector sample. Bipolar Disord. 2000 Dec;2(4):340-6. doi: 10.1034/j.1399-5618.2000.020409.x.

  PMID: 11252648 BACKGROUND

• Harvey RF, Bradshaw JM. A simple index of Crohn's-disease activity. Lancet. 1980 Mar 8;1(8167):514. doi: 10.1016/s0140-6736(80)92767-1. No abstract available.

  PMID: 6102236 BACKGROUND

• Walmsley RS, Ayres RC, Pounder RE, Allan RN. A simple clinical colitis activity index. Gut. 1998 Jul;43(1):29-32. doi: 10.1136/gut.43.1.29.

  PMID: 9771402 BACKGROUND

• Bhangle SD, Kramer N, Rosenstein ED. Corticosteroid-induced neuropsychiatric disorders: review and contrast with neuropsychiatric lupus. Rheumatol Int. 2013 Aug;33(8):1923-32. doi: 10.1007/s00296-013-2750-z. Epub 2013 Apr 16.

  PMID: 23588411 RESULT

• Brown ES, Chamberlain W, Dhanani N, Paranjpe P, Carmody TJ, Sargeant M. An open-label trial of olanzapine for corticosteroid-induced mood symptoms. J Affect Disord. 2004 Dec;83(2-3):277-81. doi: 10.1016/j.jad.2004.07.001.

  PMID: 15555725 RESULT

MeSH Terms

Conditions

Inflammatory Bowel Disease 11; Inflammatory Bowel Diseases

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Greg Rosenfeld, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2013
• First Posted: November 13, 2013
• Study Start: October 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: August 1, 2016
• Last Updated: November 2, 2016

Record last verified: 2016-10

Locations

CA (1)