healthy volunteers 'depression, anxiety' MedDRA version: 15.1 Level: PT Classification code 10012378 Term: Depression System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 15.1 Level: PT Classification code 10002855 Term: Anxiety System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: Zoloft
Pharmaceutical Form: Capsule
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Sponsors
Centre for Human Drug Research
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine functional connectivity alterations after a serotonergic challenge in healthy volunteers.;Secondary Objective: 1) To investigate how cognition is affected after a serotonergic challenge. 2) To determine how this pharmacologically induced change in cognition is related to functional connectivity changes in the brain. 3) To assess the feasibility of pharmacokinetic/pharmacodynamic (PK/PD)-analyses for pharmacologically induced fMRI-activation patterns. 4) To explore whether the findings with sertraline are qualitatively similar to the findings with citalopram in study HDR1203-A. ;Primary end point(s): Resting State Network functional connectivity;Timepoint(s) of evaluation of this end point: -1, 3, 4.5, 6, 7.5 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Cognitive functioning as measured with Neurocart subtests: • Visual Analogue Scale (VAS) Bond & Lader (mood, alertness and calmness) • VAS for nausea • Adaptive tracking • Simple reaction time • Stroop test • Symbol-digit substitution test • Visual N-back test • Visual Verbal Learning Test (VVLT; 30 words) PK-parameters of sertraline;Timepoint(s) of evaluation of this end point: Cognitive functioning: at -1, 3, 4.5, 6, 7.5 PK-parameters: -1, 1.5, 3, 4.5, 5, 6, 7.5 | — |
Countries
Netherlands
Contacts
Public ContactCHDR
Centre for Human Drug Research
Outcome results
None listed