This trial investigates the effectiveness of inhaled insulin as a treatment for cognitive dysfunction (memory and thinking) in individuals with bipolar disorder (BD). Insulin is a widely used treatment for diabetes due to its effect on glucose homeostasis. When delivered through the nose, insulin can enter the brain and potentially effect cognitive function (memory and thinking).
We have collected pilot data showing that inhaled insulin is safe, effective and well tolerated in improving a type of cognition in individuals with BD. Therefore, we are conducting a larger randomised controlled trial to investigate the efficacy of insulin for cognitive dysfunction in individuals with BD.
To participate in the study, you must:
- have bipolar disorder
- be experiencing a relatively stable mood state
- aged between 18 and 55
- no other significant untreated health conditions
There are additional criteria, which will be assessed throughout a phone and in-person screening session. To enter into the trial, individuals will also need to have some memory and thinking difficulties, which will be formally assessed. If individuals are ineligible for the trial due to normal memory and thinking skills, it is possible to still be involved in the research by completing two study visits without entering the 12-week trial.
As part of the trial, individuals will be randomised to receive insulin treatment or placebo, which will be self-administered through a nasal spray bottle twice a day for 12 weeks. Participants will be required to attend three testing sessions on the Hawthorn campus of Swinburne University of Technology for approximately four hours each.
You will be reimbursed for your time and contribution: individuals who complete the trial will be reimbursed $120, and individuals who complete the two visits without entering into the trial will receive $60.
During the testing sessions you will be asked to complete:
- interview on mental health functions and symptoms
- assessment of medical status and history
- blood tests
- memory and thinking tests
- questionnaires on social functioning
- basic physiological assessments (e.g. blood pressure)
For more information, or to find out if you are eligible, please contact the study researchers via email@example.com or call Nicola Acevedo (Trial Coordinator) on +61 3 9214 3427.