None listed
Conditions
Brief summary
The efficacy, safety, and tolerability of daily intranasal insulin as a potential treatment for neurocognitive deficits in bipolar disorder (BD) will be investigated in a randomised controlled trial (RCT) across 12 weeks. Neurocognitive deficits are common in BD and can cause significant impairment in everyday functioning. Currently, there are no recommended treatments for neurocognitive deficits in BD, antipsychotics might aggravate cognition and the first line treatment for BD (lithium) has uncertain pro-cognitive effects. Thus, advances in the treatment of neurocognitive deficits in BD are urgently needed. The current study will investigate the efficacy of insulin in improving global neurocognition and psychosocial functioning in people with BD. The safety and adherence of the treatment will also be assessed. This novel clinical trial has the potential to be transformational for people with BD given the critical need to improve neurocognition and psychosocial functioning in those who experience it.
Interventions
The intervention includes intranasal insulin, Levemir (Determir). Insulin is a standard treatment for diabetes, and has been extensively investigated for cognitive function in clinical trials. Delivery through the nasal has advantages in bypassing the peripheral bloodstream, allowing direct delivery to the brain, without systematic insulin increases. The role of insulin in cognitive function has been demonstrated in several populations, and has shown to be a safe, tolerable, and effective treatm
The intervention includes intranasal insulin, Levemir (Determir). Insulin is a standard treatment for diabetes, and has been extensively investigated for cognitive function in clinical trials. Delivery through the nasal has advantages in bypassing the peripheral bloodstream, allowing direct delivery to the brain, without systematic insulin increases. The role of insulin in cognitive function has been demonstrated in several populations, and has shown to be a safe, tolerable, and effective treatment for cognition. Levemir is a long acting insulin, when administered via inhalation, the onset of and duration of action is between 3-4 hours and 6-23 hours, respectively. 40 international units (IU) of inhaled insulin Levemir will be self-administered daily. Each dose will consist of 20IU (each actuation or puff being 10IU, 1 puff administered per nostril), two times per day (before breakfast, before dinner), evenly between nostrils, for 12 weeks. During the trial, participants will be requested to log drug administration in an app. At completion of the trial, bottles wil be returned and assessed for adherence.
Sponsors
Swinburne University of Technology
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
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
i) Aged between 18-55 years (inclusive) ii) Primary diagnosis of bipolar disorder type I or II according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) iii) Score <12 on the Montgomery-Asberg Depression Rating Scale (MADRS) and <8 on the Young Mania Rating Scale (YMRS) to ensure euthymia iv) Perform atleast 1.0 standard deviations below the normative mean on the Screen for Cognitive Impairment in Psychiatry (SCIP) v) Demonstrate an estimated IQ >79 assessed by the Weschler Abbreviated Scale of Intelligence (WASI) to ensure that study instructions can be understood vi) Have been stabilised on psychotropic medications for 4 weeks, if prescribed vii) Utilising effective contraception if female and of childbearing age viii) Have capacity to consent to the study
Exclusion criteria
i) Concurrent DSM-5 diagnosis (including personality disorders) as the primary clinical concern determined by a treating clinician ii) Not fluent in, or able to read English iii) Enrolled in any other intervention study iv) Clinically significant untreated medical condition (e.g., cardiovascular, gastrointestinal, haematological, renal, hepatic, respiratory or endocrine illnesses) v) A history of neurological trauma resulting in loss of consciousness >10 minutes, or previously diagnosed with any known neurological disorder vi) Currently pregnant or breastfeeding vii) Ongoing sinus condition viii) Untreated hypo / hyperthyroidism ix) Current or history of diabetes mellitus type I or type II or hypo / hyperglycaemia x) Currently taking corticosteroids, anticholinergics, or anti-diabetic medication xi) Electroconvulsive therapy in the preceding 6 months xii) Substance or alcohol abuse/ dependence in the last 3 months (meeting DSM-5 criteria) xiii) Body mass index (BMI) equal or greater than 40 kg / m2 xiv) Actively suicidal or deemed at suicide risk as evaluated by their treating clinician or screening clinical assessments.
Outcome results
None listed