Antidepressants to maintain remission and improve quality of life and mental health in Crohn’s disease (CD) patients: A pilot randomised controlled trial

Phase 4

Completed

• Conditions: inflammatory bowel disease; Oral and Gastrointestinal - Inflammatory bowel disease

• Registration Number: ACTRN12612001067864
• Lead Sponsor: niversity of South Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-10-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

Inclusion criteria
Patients had to meet ALL of the following criteria:
1). Established diagnosis of CD;
2). Remission or only mild symptoms of CD (CDAI <150);
3). Have flared CD in the last 12 months (as documented by their treating doctor and demonstrated by either raised inflammatory markers, augmented therapy, high CDAI or calprotectin);
4). Be on stable dose of all their current CD therapies for 12 weeks;
5). Be 18 years old or older;
6). Have a sufficient knowledge of English to understand and answer questionnaires.
7). Have the ability to consent to the study.

Exclusion Criteria

Exclusion criteria
Patients were excluded if they met ANY of the following:
1). Have serious uncontrolled mental illness (e.g. schizophrenia) or are alcohol/substance dependant;
2). Currently taking antidepressants;
3). Currently receiving psychotherapy;
4). Currently taking steroids >15mg or equivalent;
5). Are allergic to fluoxetine or any component of placebo;
6). Are pregnant or breastfeeding;
7). Have cognitive impairment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measure was a significant difference in means and proportions of participants in remission on the Crohn's Disease Activity Index (CDAI).[3, 6 and 12 months.];The primary outcome measure was a significant difference in means on the World Health Organisation Quality of Life measure (WHOQoL).[3, 6 and 12 months.]

Secondary Outcome Measures

Name	Time	Method
The secondary outcome measures was a difference in means on the fecal calprotectin test.[3, 6 and 12 months.];The secondary outcome measures was a difference in means on the Hospital Anxiety and Depression Scale (HADS).[3, 6 and 12 months.];The secondary outcome measures were differences in means of cytokine/chemokines (changes towards more anti-inflammatory balance) assessed on the serum assays.[3, 6 and 12 months.]