Treatment of clozapine associated obesity and diabetes with exenatide in people with schizophrenia

Phase 4

• Conditions: Treatment resistant schizophrenia; obesity; diabetes; Metabolic and Endocrine - Diabetes; Mental Health - Schizophrenia; Diet and Nutrition - Obesity

• Registration Number: ACTRN12615000524594
• Lead Sponsor: The University of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-26
• Study Completion: 2017-07-21
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

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 Arm B
a) BMI greater than or equal to 30kg/m2 and less than 45kg/m2

Exclusion Criteria

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/hyperthyroidism
Acute or chronic pancreatitis or high risk of pancreatitis
Concurrent use of insulin
For Arm 2: Diagnosis of Diabetes Mellitus Type I or Type II

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Weight loss for subjects in Arm 1, as measured by the proportion of people with >5% weight loss.[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.];Weight loss for subjects in Arm 2, as measured by the proportion of people with >5% weight loss.[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.];Acceptability as assessed by a patient-reported outcome questionnaire (designed specifically for this study).[Patient-report outcomes will be assessed after 12 and 24 weeks. ]