Clozapine Induced Weight Gain

Cwm Taf University Health Board (NHS)

Status: Unknown

Conditions: Antipsychotic Agents; Weight Gain; Pharmacogenetics

Treatments: Other: No study intervention - observational study

Study type: Observational

Funder types: Other

Identifiers

NCT03996356

CT/688/000000/16

Details and patient eligibility

About

Clozapine is prescribed to patients with psychosis in whom other treatments have not worked. Research has shown, however, that clozapine may be associated with weight gain and abnormal blood sugar levels in some patients. There is strong evidence to suggest that genetic variation between individuals plays an important role in the development of these side effects in response to the medication. Our research aims to evaluate the effects of two genes and the blood level of clozapine on side-effects such as weight changes and blood sugar levels in patients receiving clozapine treatment. From out-patient clinics in Cwm Taf UHB, the investigators aim to recruit 160 patients who are taking clozapine; collect information/ measurements from recruits relating to size/ weight/ BMI, risk of diabetes and blood samples to measure markers of blood sugar, fat/lipids, clozapine and its breakdown products, blood cells and variants of two specific genes. From this information the investigators will be particularly interested to understand if there is any association between the variation in these two genes with weight gain or changes in blood sugar, in patients taking clozapine.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 years or over
• Taking/compliant with clozapine antipsychotic medications.
• Patients meeting the ICD-10 criteria for a diagnosis of schizophrenia, schizoaffective or borderline personality disorders.

Exclusion criteria

• History of current alcohol/illicit substance dependency.
• Unable/ unsuitable to complete the study protocol e.g. acutely ill, suicidal or aggressive patients.
• Unable to consent to the study.