Australian Clinical Trials

Broad Health Condition Mental Health

Specific Health ConditionPsychosis and personality disorders

Trial FocusTreatment

Recruitment Details

Recruitment status
Recruiting

Recruitment State
VIC

Hospital
St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Postcode
3065 - Fitzroy

Anticipated date of first participant enrolment1/08/2022

Anticipated date of last participant enrolment1/06/2024

Phase of TrialPhase 2

Has the study received ethics approval?Approved

Trial 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.  

Key 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

Minimum age18 Years

Maximum age55 Years

GenderBoth males and females

Can Healthy volunteers participate? No

Key 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.