Intranasal insulin for neurocognition in bipolar disorder

Phase 2

Recruiting

• Conditions: Bipolar disorder; neurocognition; Mental Health - Psychosis and personality disorders

• Registration Number: ACTRN12622000669796
• Lead Sponsor: Swinburne University of Technology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-09
• Last Update Posted: 26 September 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified