WithdrawnNot Applicable

Cognitive and Psychiatric Effects of Linaclotide on Patients With Constipation

Canada0Started 2016-03

Plain-language summary

Irritable Bowel syndrome - constipation predominant (IBS-C) is a chronic and disabling,disorder of the gut that is characterized by abdominal pain or discomfort. Approximately 50% of patients with IBS-C will also meet criteria for anxiety or depression. Anti depressant medication is widely used in the treatment of IBS. Linaclotide is a novel medication for IBS that is also effective at relieving pain associated with IBS, which may be in part to signalling between the gut and the brain. However, the impact of Linaclotide on the psychiatric symptoms of anxiety and depression on IBS has not been investigated.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * IBS-C or CIC as defined by Rome III criteria * able to provide and sign informed consent * age 18-65 years Exclusion Criteria: * Previous diagnosis of bipolar, schizophrenia, or schizoaffective disorder * psychosis * active suicidal thoughts * presence of a major neurocognitive disorder, delirium or other cognitive disorder * active substance dependence ( including the use of cannabis more than 3 times per week * active eating disorder * pregnant or breastfeeding

What they're measuring

To measure anxiety and depression using the Depression, Anxiety and Stress Scale (DASS) in patients with IBS-C and CIC before and after treatment with Linaclotide

Timeframe: Change from baseline to week 8

Trial details

NCT IDNCT03342287

SponsorMcMaster University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-12

View on ClinicalTrials.gov More Constipation trials