E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
healthy volunteers 'depression, anxiety' |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 15.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10012378 |
E.1.2 | Term | Depression |
E.1.2 | System Organ Class | 10037175 - Psychiatric disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 15.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10002855 |
E.1.2 | Term | Anxiety |
E.1.2 | System Organ Class | 10037175 - Psychiatric disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine functional connectivity alterations after a serotonergic challenge in healthy volunteers. |
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E.2.2 | Secondary objectives of the trial |
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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
Resting State Network functional connectivity |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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 |
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E.5.2.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |