None listed
Conditions
Brief summary
This study aims to answer the following research question: Is metformin pharmacotherapy for 12 months as an adjunctive therapy to a 12-week lifestyle behavioural intervention program targeting physical activity, diet and sleep hygiene practices effective in improving clinical cardiometabolic health parameters and affective symptoms of young people with a clinically diagnosed mood or psychotic syndromes? The study will run for approximately 3 years. The total duration for each participant is 52 weeks involving 52 weeks of metformin/placebo, 12 weeks of lifestyle behavioural intervention, intermittent actigraphic assessments, and follow up at 12, 26, 38, and 52 weeks. Investigators expect to enrol 266 people in this trial.
Interventions
The study is designed as a double-blind, randomised placebo-controlled clinical trial. Participants will be randomly allocated to receive either oral metformin (initially 500mg daily, titrated up to 1000mg daily after 2 weeks) or placebo over a period of 52 weeks in adjunct to a 12-week Healthy Lifestyle Behavioural Modification Intervention (HLBMI) program.
This will involve pre-constructed psychoeducational intervention in the form of lectures/PowerPoint presentations and advice on various to
The study is designed as a double-blind, randomised placebo-controlled clinical trial. Participants will be randomly allocated to receive either oral metformin (initially 500mg daily, titrated up to 1000mg daily after 2 weeks) or placebo over a period of 52 weeks in adjunct to a 12-week Healthy Lifestyle Behavioural Modification Intervention (HLBMI) program. This will involve pre-constructed psychoeducational intervention in the form of lectures/PowerPoint presentations and advice on various topics (dietary, physical activity, sleep-wake and healthy lifestyle advice) over 7 face-to-face sessions delivered fortnightly by a research assistant (week 1, 3, 5, 7, 9, and 11). Fortnightly sessions will be 1 hour in duration. A standard operating procedure will be provided for the psychoeducation sessions to ensure a standardisation of the intervention. Each psychoeducation session will target different healthy behavioural changes and the principles will be reinforced at each subsequent face-to-face session with the research assistant. Throughout the 12-week psychoeducation sessions, participants will be encouraged to set achievable goals for lifestyle changes and will be able to self-monitor their progress using the booklets provided. During this time, participants will also be asked to complete a sleep diary and to wear an actigraph (GENEActiv Sleep device) on the non-dominant wrist throughout the duration of the study. Two-week actigraphy recordings will also be collected during weeks 1-2, 11-12, 25-26, 37-38 and 51-52. Anthropometric assessments (including blood samples), self-report and clinician administered questionnaires will be conducted in weeks 1, 12, 26, 38 and 52. Participants will be provided with a hand-out compliance diary and will be encouraged to tick off each day they have taken their tablets along with noting any side effects. Participants will be asked to bring in their pill bottle at the end of the 90 days (each bottle contains 90 days worth of investigational product supply) and the remaining pills will be counted as a further measure of compliance. Additionally, a monthly safety contact in the form of an sms will be conducted to monitor compliance and side effects.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
16 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
- Aged between 16 and 25 - A current diagnosis of a mood or psychotic syndrome (including anxiety, depression, bipolar disorder and psychosis) according to the Diagnostic and Statistical Manual of Mental Disorders, version V (DSM-IV) criteria using the Structured Clinical Interview for DSM-5 (SCID) - Independent written informed consent given by the subject - BMI greater than 25 (overweight or obese) AND AT LEAST ONE OF THE FOLLOWING - HOMA-2IR value greater or equal to 1.5 - Currently on and/or commencing psychotropic medication (antipsychotics, antidepressants, mood stabilizers) under psychiatric supervision - Mental illness has reached Stage 2- “Discrete Disorders” in the Clinical staging model framework for mood and psychotic syndromes
Exclusion criteria
• Those not competent to provide informed consent • Lifetime use of metformin or any other glucose lowering medication • Lifetime diagnosis of T1 or T2DM diabetes (gestational diabetes accepted) • Intellectual disability (at investigator’s discretion); • Major neurological disorder, medical illness which impacts on cognition, and/or a history of sustained head injury; • Not fluent in English • Significant alcohol or other substance misuse or substance dependence; • An acute psychotic or manic episode that impairs the individual’s ability to give informed consent and/or requires acute clinical treatment • Acute suicidal behaviour (score of 6 on Comprehensive Assessment of At-Risk Mental States (CAARMS) item 7.3) • Contraindications to metformin including acute alcohol intoxication or severe infection. • Current pregnancy, lactation, or plans to become pregnant
Outcome results
None listed