CODEX
ACTRN12615000524594
Treatment
Phase 4
Hospital,Princess Alexandra Hospital Research Support Scheme
A/Prof Dan Siskind
Schizophrenia has a lifetime risk of 7.2 per 1000 persons with 25-50% of people with schizophrenia failing to respond to typical and atypical antipsychotics. For these people clozapine is the gold standard treatment, however, clozapine greatly increases the risk of weight gain and type 2 diabetes (T2DM) which contribute to cardiovascular disease and premature mortality. Current interventions against antipsychotic-associated metabolic dysregulation are limited and insufficient. The mechanism of a .... Read more
Provision of informed consent prior to any study specific procedures Clinical diagnosis of Schizophrenia or Schizoaffective Disorder On oral clozapine for at least 18 weeks Stable body weight (defined as less than 5kg change in weight over the past 3 months before inclusion) For Arm A a) Diagnosis of Type II Diabetes Mellitus b) Current and stable therapeutic doses of oral glucose lowering agents for 3 months prior to recruitment c) BMI greater than or equal to 30kg/m2 and less than 45kg/m2 For .... Read more
Pregnancy or lactation Severe gastrointestinal disease Severe renal impairment Allergy/hypersensitivity to investigational product Obesity due to other endocrinologic disorder (e.g Cushing Syndrome) Treatment with corticosteroids or other hormone therapy (except oestrogens or thyroxine) for greater than 10 days Current use of any weight-lowering therapy or previous surgical treatment of obesity Uncontrolled hypertension History of thyroid adenoma or carcinoma Untreated or uncontrolled hypo/hyper .... Read more
No
Sample Size 28
Min. age 18 Years
Max. age 64 Years
Sex Both males and females
Condition category Treatment resistant schizophrenia , diabetes , obesity
Condition code Diet and Nutrition , Mental Health , Metabolic and Endocrine
Intervention code Treatment: Drugs
Participants will be assigned to Arm 1 or Arm 2 depending on their clinical diagnosis and then randomised to the control or intervention group. Arm 1: clozapine-treated people with Type 2 Diabetes Mellitus (T2DM). Intervention group: once weekly exenatide subcutaneous injection (2mg) delivered by a mental health or trial nurse for 24 weeks. Exenatide will be administered in addition to current glucose lowering agents. Note: For participants in the intervention group who are already on a sulfonyl .... Read more
Control group Active
Treatment as usual – no additional drugs or placebo
Outcome: Weight loss for subjects in Arm 1, as measured by the proportion of people with >5% weight loss.Timepoint: Body weight will be measured at baseline and at each 4-weekly study visit. Body weight at endpoint (week 24) will be evaluated against baseline weight.
Outcome: Weight loss for subjects in Arm 2, as measured by the proportion of people with >5% weight loss.Timepoint: Body weight will be measured at baseline and at each 4-weekly study visit. Body weight at endpoint (week 24) will be evaluated against baseline weight.
Outcome: Acceptability as assessed by a patient-reported outcome questionnaire (designed specifically for this study).Timepoint: Patient-report outcomes will be assessed after 12 and 24 weeks.
yes
The type of data shared will depend on the conditions of an HREC waiver, as current ethical approval does not allow for sharing of IPD.
The availability of the data will depend on the conditions of an HREC waiver, as current ethical approval does not allow for sharing of IPD.
Data are potentially available to: - Researchers from academic institutions Based in: - Any location Further information: All data requests will be considered by the primary sponsor and is subject to an HREC waiver, considered on a case-by-case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted. For further information, see our data sharing policy (https://ppl.app.uq.edu.au/content/4.20.06-research-data-management).
The types of analyses available will depend on the conditions of an HREC waiver, as current ethical approval does not allow for sharing of IPD.