The efficacy of Metformin as an adjunctive treatment to attenuate weight gain and metabolic syndrome in patients with schizophrenia or schizoaffective disorder newly commenced on clozapine

Phase 4

Recruiting

• Conditions: Schizophrenia; obesity; metabolic syndrome; schizoaffective disorder; Mental Health - Schizophrenia; Diet and Nutrition - Obesity; Metabolic and Endocrine - Metabolic disorders

• Registration Number: ACTRN12617001547336
• Lead Sponsor: The University of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-09
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

1.Aged between 18 and 64 years (inclusive)
2.Fulfil the DSM-IV criteria practice for schizophrenia or schizoaffective disorder, based on the Diagnostic Interview for Psychosis (DIP)
3.Have received oral clozapine for a period of no more than 2 weeks
4.Agree to participate, have capacity to consent and are able to follow the study instructions and procedures
5.Fasting Blood Glucose Level less than or equal to 5.6 mmols (confirmed within the previous two weeks of commencing clozapine)
6.BMI greater than or equal to 18 and less than or equal to 40

Exclusion Criteria

1.Known allergies to Metformin or any part of the formulation of the investigational product
2.Obesity induced by other endocrinologic disorder (e.g Cushing Syndrome, untreated
Hypothyroidism)
3.Current use of any weight-lowering therapy including: pramlintide, sibutramine, orlistat, zonisamide, topiramate or phenteremine (either by prescription or as part of a clinical trial)
4.Diagnosis of Type 1 or Type 2 Diabetes mellitus or already on metformin
5.Participants treated with corticosteroids or other hormone therapy (except oestrogens or thyroxine) for greater than 10 days
6.Chronic kidney disease (eGFR<60mL/min)
7.Previous surgical treatment of obesity
8.BMI less than or equal to 18 or BMI greater than or equal to 40
9.Any concomitant disease or condition that according to the investigator’s assessment makes the patients unsuitable for trial participation
10.People who are unable to understand or communicate in English

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Weight will be used as the primary outcome measure and will be conducted by research assistants using calibrated digital scales.[24 weeks assessment]

Secondary Outcome Measures

Name	Time	Method
Rate of conversion to T2DM. This will be defined from pathology results of fasting 2 hour glucose tolerance test and HbA1c)[24 week assessment];Metabolic syndrome will be assessed from pathology blood results [24 weeks assessment];Homeostatic model assessment (HOMA) of insulin resistance and secretion based on fasting glucose and insulin blood results[24 weeks assessment];Metabolic bloods (glucagon) [24 weeks assessment];Diet and appetite (Food Craving Inventory)[24 weeks assessment];Liver function blood tests[24 week assessment]