Clinical trial NCT03943537: Effects of Intranasal Insulin on Neuroimaging Markers and Cognition in Patients With Psychotic Disorders
Official title: Effects of Intranasal Insulin on Neuroimaging Markers and Cognition in Patients With Psychotic Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psychosis
Schizophrenia
Schizo Affective Disorder
Bipolar I Disorder
Keywords: Psychosis
Insulin
Brain Metabolism
Cognition
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
First posted: 2019-05-09
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This clinical trial is a single center, single dose study of the acute effects of intranasal insulin on energy metabolism and cognitive function in patients with schizophrenia, schizoaffective and bipolar disorders, compared and healthy controls.

Detailed description: Psychotic disorders are common and severe psychiatric disorders. Despite advances in understanding the pathophysiology of these disorders, more effective and tolerable treatments are still needed. Evidence suggests that energy metabolism is altered in psychotic disorders. The investigators recently developed non-invasive MRI-based techniques to quantify redox balance and ATP generation in the brain. Targeting insulin pathways in the brain may allow for modulating abnormalities in energy metabolism. The investigators seek to examine whether intranasal insulin can modulate energy metabolism and improve cognition in patients with psychotic disorders. The study will use magnetic resonance spectroscopy (MRS) technology to measure in vivo energy metabolism processes in the brain, before and after the administration of intranasal insulin. Investigators will also measure changes in cognition with the administration of intranasal insulin.

Eligibility criteria: Inclusion Criteria:

* Diagnostic and Statistical Manual of Mental Disorders (DSM) diagnoses of schizophrenia, schizoaffective disorder or bipolar disorder with psychotic features OR
* Healthy Controls (no history of DSM psychiatric diagnoses, nor history of the same in first-degree relatives)

Exclusion Criteria:

* Psychiatric hospitalization within the last 4 weeks
* Unstable/active disease or potential contraindications, such as liver disease, kidney disease, uncontrolled hypertension, significant or unstable medical illness
* Currently prescribed: antidiabetic agents, including oral antidiabetic medications and insulin, intranasal medication, steroids, weight loss agents
* Pregnant or breast-feeding, not using an effective form of contraception for at least 3 months, and/or not abstinent for 1 month prior to enrollment
* History of significant head injury
* Contraindication to MRI scans (claustrophobia, cardiac pacemakers, metal clips and stents on blood vessels, artificial heart valves, artificial arms, hands, legs, etc., brain stimulator devices, implanted drug pumps, ear implants, eye implants or known metal fragments in eyes, exposure to shrapnel or metal filings, other metallic surgical hardware in vital areas, certain tattoos with metallic ink, certain transdermal patches, metal-containing IUDs).
* Medical conditions preventing blood draws
* History of electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) within the last 3 months
* BMI \> 35 or body weight \> 350 lbs or BMI \<18
* DSM diagnosis of substance use disorder in the past month
* For Healthy Controls:
* Taking medication other than birth control

Primary outcomes:
measure: Changes in Brain Redox State
timeFrame: 6 hours, pre- and post- 40 IU intranasal insulin
measure: Changes in Brain ATP
timeFrame: 6 hours, pre- and post- 40 IU intranasal insulin
measure: Changes in Brain PCr
timeFrame: 6 hours, pre- and post- 40 IU intranasal insulin
measure: Changes in Brain CK
timeFrame: 6 hours, pre- and post- 40 IU intranasal insulin
measure: Changes in STROOP Color-word Interference Score
timeFrame: 6 hours, pre- and post- 40 IU intranasal insulin
measure: Changes in BACS Digit Sequencing Score
timeFrame: 6 hours, pre- and post- 40 IU intranasal insulin
measure: Changes in BACS Symbol Coding
timeFrame: 6 hours, pre- and post- 40 IU intranasal insulin
measure: Changes in BACS Verbal Fluency Scores
timeFrame: 6 hours, pre- and post- 40 IU intranasal insulin
Secondary outcomes:
measure: Changes in Brain pH.
timeFrame: 6 hours, pre- and post- 40 IU intranasal insulin
measure: Changes in Brain Inorganic Phosphate Concentration.
timeFrame: 6 hours, pre- and post- 40 IU intranasal insulin
measure: Change in Fasting Blood Glucose Levels.
timeFrame: 6 hours, pre- and post- 40 IU intranasal insulin
measure: Change in Fasting Blood Insulin Levels.
timeFrame: 6 hours, pre- and post- 40 IU intranasal insulin
measure: Change in Brain Glutamate Concentration
timeFrame: 6 hours, pre- and post- 40 IU intranasal insulin
measure: Changes in Brain Glutamine Concentration
timeFrame: 6 hours, pre- and post- 40 IU intranasal insulin
measure: Changes in Brain Glutathione Concentration
timeFrame: 6 hours, pre- and post- 40 IU intranasal insulin
Other outcomes:
Locations:
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
Study officials:
affiliation: Mclean Hospital
name: Virginie-Anne Chouinard, M.D.
role: PRINCIPAL_INVESTIGATOR
References: