A neuro-imaging study on the role of fatty acids in cognitio

Phase 1

• Conditions: This study will assess the effects of poly-unsaturated fatty acids on working memory (measured using an n-back test) in healthy volunteers, in subjects who are at high risk for developing a psychotic disorder and in patients with first-episode schizophrenia.; MedDRA version: 20.0Level: HLGTClassification code 10039628Term: Schizophrenia and other psychotic disordersSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Psychological processes [F02]

• Registration Number: EUCTR2016-004970-16-AT
• Lead Sponsor: Medizinische Universität Wien

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-14
• Last Update Posted: 8 January 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

All subjects
•age 18-65
•good general health
•absence of relevant abnormalities in laboratory screening, ECG or vital signs
•no regular use of drugs of abuse or alcohol based on history and urine drug screen.
Healthy subjects
•Absence of psychiatric disorders according to M.I.N.I.
ARMS subjects
•CAARMS above ARMS threshold
Patients with schizophrenia
•diagnosis of SCZ or other non-affective psychotic disorder according to DSM-5
•minimum Positive and Negative Syndrome Scale (PANSS) total score of 55 (> 3 on at least two or >4 on one psychosis item
•ability to give informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 66
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

All subjects
•severe or unstable medical or neurologic disorders or clinically significant abnormality on screening laboratory studies
•clinically relevant abnormalities in the electro-cardiogram (ECG)
•history of myocardial infarction or angina pectoris, arterial hypertension or paroxysmal hypertensive states
•established diagnosis of advanced arteriosclerosis or hyperthyroidism
•current substance use disorder (except nicotine)
•lifetime use of stimulants exceeding 5 or more exposures
•pregnancy or breast feeding
•known hypersensitivity to sympathomimetics
•history of severe head trauma
•positive urine drug screen
•presence of MRI exclusion criteria
•if participation in this study would exceed annual radiation dose limits (30mSv)
•known allergy to any ingredients of the PUFA or placebo capsules
•Patients with schizophrenia
•previous oral antipsychotic treatment for more than 2 weeks, or antipsychotics within two weeks prior to PET scan; previous treatment with antipsychotic depot preparation.
•ARMS subjects
•psychotic disorder according to DSM-5 (CAARMS above psychosis threshold)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified