Effects of the appetite-inducing hormone ghrelin on decision making in healthy volunteers

Phase 1

• Conditions: A, healthy volunteers; Therapeutic area: Psychiatry and Psychology [F] - Behaviours [F01]

• Registration Number: EUCTR2018-004829-82-SE
• Lead Sponsor: inköping University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-14
• Last Update Posted: 19 December 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

1.Age 18-65 years.
2.Good health as determined by medical history, ECG and clinical assessment of lab tests. Lab tests will include sodium, potassium, creatinine, hemoglobin, EVF, erythrocytes, leukocytes, platelets, MCV, MCH, MCHC, albumin, bilirubin, plasma lipids, ALP, ASAT, ALAT, CRP, GT. The final decision will be according to the judgment of the investigator.
3.Creatinine = 176 µmol/L.
4.Females must have a negative urine pregnancy test (hCG) at inclusion and at the start of each study session. Females of childbearing potential who are sexually active and have not been surgically sterilized must agree to use an adequate method of birth control during the study.
5.Participant must be willing to receive two IV lines.

Inclusion criteria specific for study 1
Participant must be willing to undergo an MR scan.

Inclusion criteria specific for study 2
Proficiency in Swedish.

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 74
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Any clinically significant medical condition, including CNS, cardiovascular, respiratory, gastrointestinal, hepatic, renal, endocrine, or reproductive disorders.
2.Specific exclusion criteria related to the administration of ghrelin are chronic inflammatory diseases (e.g., Crohn’s disease, ulcerative colitis, celiac disease), diabetes, obesity (BMI = 30 kg/m2), weight = 120 kg, high triglycerides level (> 4,0 mmol/l), history of clinically significant hypotension (e.g., history of fainting and/or syncopal attacks) and/or resting systolic BP < 100 mmHg.
3.Any use of CNS-active medications.
4.Unable to provide a negative urine drug screen (including amphetamine, THC, opiates and benzodiazepines).
5.Pregnancy, intention to become pregnant, or breastfeeding a child.

Exclusion criteria specific for study 1
1.Any current clinically significant psychiatric problems including a diagnosis of substance dependence other than nicotine; any history of a past eating disorder, psychotic illness, or bipolar disorder; as determined by medical history, and MINI interview carried out by appropriately trained staff.
2.Contraindications for MRI scanning, including ferromagnetic objects in the body that are contraindicated for MRI, and claustrophobia.

Exclusion criteria specific for study 2
1.Any current clinically significant psychiatric problems including a DSM-5 diagnosis of severe Substance Use Disorder other than nicotine, or Gambling Disorder. Patients will be screened using the Modified MINI Screen [MMS, (43)], the Alcohol Use Disorder Identification Test [AUDIT; (44)], the Drug Use Disorder Identification Test (DUDIT; (45)] and the NORC Diagnostic Screen for Gambling Problems [NODS; (46)]. The results and their clinical significance will be evaluated by a trained healthcare professional (psychiatrically trained nurse or physician). If an indication is obtained that a clinically significant psychiatric disorder may be present, a full structured diagnostic interview [MINI; (47)] will be carried out by appropriately trained staff prior to determining eligibility.
2.Any lifetime history of problematic gambling.

Study & Design

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