None listed
Conditions
Brief summary
Clozapine, an antipsychotic used in treatment-resistant schizophrenia, causes marked gastrointestinal hypomotility in 50-80% of patients. Clozapine-induced gastrointestinal hypomotility is both common and serious; it can result in severe constipation, ileus, bowel obstruction and related complications. Little evidence exists on its prevention and management. Subjective constipation has been found unreliable in predicting objective hypomotility. In this study, using a standardized radiopaque marker (‘Metcalf’) method we compare the colonic transit times of clozapine-treated inpatients at baseline (while not receiving laxatives) with transit times when receiving laxatives, with treatment prescribed according to the Porirua Protocol (see attachment) for clozapine-related constipation (docusate & senna augmented by macrogol 3350 in treatment-resistant cases). Treatment is guided by the Protocol (which is standard treatment at the clinical site this research took place in) and not manipulated by the researchers. Our objective was to determine in this naturalistic setting whether use of the Porirua Protocol in clozapine-treated psychiatric inpatients changed gastrointestinal motility. Methods were specified a-priori in the protocol, published in the University of Otago Research Archive (http://hdl.handle.net/10523/6392).
Interventions
The condition observed is colonic transit time (as measured by radiopaque marker studies using the Metcalf technique). The exposure is laxative treatment prescribed according to the Porirua Protocol (which is attached). At the first timepoint colonic transit time was measured in the absence of the Porirua Protocol. Participants were then established on the Porirua Protocol by their clinical teams (the Protocol is treatment as usual in the service where this study takes place. The study design wa
The condition observed is colonic transit time (as measured by radiopaque marker studies using the Metcalf technique). The exposure is laxative treatment prescribed according to the Porirua Protocol (which is attached). At the first timepoint colonic transit time was measured in the absence of the Porirua Protocol. Participants were then established on the Porirua Protocol by their clinical teams (the Protocol is treatment as usual in the service where this study takes place. The study design was observational; treatment was guided by the Protocol and determined by the clinical teams and participants, treatment was not manipulated by the researchers). After at least two months of treatment on the Protocol, colonic transit time was measured again.
Sponsors
Susanna Every-Palmer
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Male and female adult patients (>18) prescribed clozapine (any dose) for at least 3 months, who are able to provide informed consent, had previously consented to baseline bowel motility testing and who have then received laxatives prescribed in accordance with the Porirua Protocol for at least two months.
Exclusion criteria
Patients under the age of 18, unable to provide informed consent or who do not understand English.
Outcome results
None listed