Characterization of 2-AG as a potential biomarker
- Conditions
- europsychiatric diseases
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 18
Healthy, male and female subjects between 25 and 65 years of age, inclusive.
- Female participants must be postmenopausal or must be on hormonal contraception for at least 6 months regulating the menstrual cycle.
- Subjects must have a BMI between > 18.0 and 30.0 kg/m2, inclusive (BMI = weight/height2).
- Subject must be healthy based on physical examination, medical history, vital signs, and 12-lead Electrocardiogram (ECG). Minor abnormalities in ECG, which are not considered to be of clinical significance by the investigator, are acceptable.
- Subjects must be healthy based on clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the subject may be included only if the investigator judges the abnormalities to be not clinically significant. This determination must be recorded
in the subject's source documents and initialed by the sub investigator.
- Subjects must be willing to adhere to the prohibitions and restrictions specified in the protocol.
- Each subject must sign an informed consent form (ICF) indicating that he or she understands the purpose and procedures required for the study and are willing to participate in the study.
- Subjects must be willing to undergo intrathecal insertion of the spinal catheter for 16 hours ±2.
- Agree to avoid any strenuous exercise from screening until the last day at the clinical research unit.
- Pregnant woman.
- Past or present history of any clinically relevant psychiatric disorder as classified according to DSM-IV or DSM 5, mood, anxiety and psychotic disorders in particular.
- Subject has a history of drug or alcohol use disorder according to DSM-IV or DSM 5 within 12 months before screening or has a positive test result(s) for alcohol and/or drugs of abuse (including but not limited to: opiates (including methadone), cocaine, amphetamines, methamphetamines, cannabinoids, barbiturates, and
benzodiazepines) at screening or admission to the clinical unit.
- Significant coagulation abnormality (e.g. hemophilia, platelet counts less than the lower limit of normal or clinically significant elevation in PT or PTT at screening), or has a medical condition requiring treatment with an anticoagulant (e.g. warfarin) or with two or more antiplatelet agents. Platelet counts between 125,000 and
150,000/microliter are permissible as long as the investigator confirms there is no evidence of current bleeding diathesis or coagulopathy.
- Subject has abnormalities upon fundoscopy indicating an increased Intracranial Pressure (ICP), unless assessed as safe by principal investigator when no further evidence is present indicating ICP.
- History of clinically significant back pathology and/or back injury (e.g. degenerative disease, spinal deformity, or spinal surgery) that may predispose to complications or technical difficulty with the spinal catheter.
- Subject smokes cigarettes (or equivalent) and/or has used nicotine-based products within 3 months prior to spinal catheter insertion ; positive cotinine test at screening and admission.
- Subject has a history of heparin allergy.
- Subject has undergone major lifestyle changes in the previous 6 months: significant weight loss > 5kg or started a specific diet which could potentially result in weight loss.
- Vulnerable subjects (e.g., a person kept in detention or a person under guardianship).
- Subject is unable to read and understand the consent forms, complete study-related procedures, and/or communicate with the study staff.
- Unsuitable veins for cannulation and/or repeated venepuncture.
- Diagnosis or suspicions of any sleep disorder in the last 6 months or current complaints of sleep disturbance, irregular sleep schedule or shift work; habitual daytime naps; travel across time zones in the last 4 weeks or daytime symptoms attributable to unsatisfactory sleep.
- Use of a prescription medicine and or over-the-counter medicine influencing the sleeping habits (such as benzodiazepines, melatonin) or occasional use (last 6 months) of cannabis (in all its forms including the use of cannabidiol (CBD)).
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method • CSF and plasma 2-AG<br>• CSF and plasma 1-AG
- Secondary Outcome Measures
Name Time Method • CSF and plasma 2-AG and 1-AG<br>• CSF BDNF<br>• plasma ACTH<br>• serum cortisol<br>• serum prolactin<br>• sleep duration, sleep onset and time to wake<br>• sleep cycles: deep, light, REM phases<br>• BMI<br>• total body fat