Study to investigate the effects of single dose administration of sertraline on brain activity in healthy volunteers.

• Conditions: healthy volunteers 'depression, anxiety'; MedDRA version: 15.1Level: PTClassification code 10012378Term: DepressionSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 15.1Level: PTClassification code 10002855Term: AnxietySystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2013-000426-62-NL
• Lead Sponsor: Centre for Human Drug Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-27
• Last Update Posted: 9 March 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Age 18-30 years, inclusive
•Body-mass index (BMI) between 18 and 30 kg/m2.
•Each subject is familiar with the procedures of the study, and agrees to participate in the study program by giving oral and written 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 12
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Contra-indication to MRI scanning (pacemaker and defibrillator, intraorbital or intraocular metallic fragments, cochlear implants, one or more metal ear tubes, intracranial clips, a non-removable insulin pump, a non-removable neurostimulator, a mechanical cardiac valve, a hydrocephalus pump, ferromagnetic implants, intra-uterine device, permanent make-up, tattoos above the shoulders, pregnancy, operation in 6 weeks preceding the MRI, claustrophobia, inability to lie still for a period of 20 minutes in the MRI scanner, fear or problems during the RS-fMRI scan).
•Relatives of study personnel directly involved with the conduct of the study, study investigators or sub-investigators.
•Clinically relevant abnormal history of physical and mental health as determined by medical history taking and physical examinations obtained during the screening visit (as judged by the investigator).
•Clinically relevant abnormal laboratory results, ECG, vital signs, or physical findings at screening (as judged by the investigator).
•Positive test for hepatitis B, C or HIV.
•Subjects using, on average, more than 4 units of alcohol per day, and unable to refrain from alcohol use during the study days.
•Subjects smoking, on average, more than 5 cigarettes per day, and unable to refrain from smoking during the study days.
•Subject is a habitual and heavy consumer of caffeinated beverages (more than 6 cups of coffee or equivalent/day) at the time of the study and/or is not able to refrain from use of (methyl) xanthines (e.g. coffee, tea, cola, chocolate) during study days.
•Positive drug or alcohol test at screening and/or study day.
•History or clinical evidence of any disease and/or existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the study drug.
•Participation in an investigational drug trial in the 3 months prior to administration of the initial dose of study drug or more than 4 times per year.
•Donation or loss of blood (> 500 mL) within 3 months prior to screening.
•Inadequate venous accessibility as judged by the physician or nurse.
•Use of benzodiazepine within 48 hours before a study day.
•Pregnancy or breast feeding.
•Any other condition that, in the opinion of the investigator, would complicate or compromise the study, or the well-being of the subject.
•Use of medication in the 2 weeks prior to the first study day.

Study & Design

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