The efficacy of adjunctive intranasal insulin for the treatment of neurocognitive dysfunction in bipolar disorder: A 12-week double blind randomised placebo controlled clinical trial.

Swinburne University of Technology0 个研究点目标入组 44 人开始时间: 2022年5月9日最近更新: 2022年9月26日

适应症

试验速览

暂无简介。

•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

•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.

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