Insomnia
Conditions
Interventions
Product Name: mirtazapine
Product Code: n/a
Pharmaceutical Form: Tablet
INN or Proposed INN: MIRTAZAPINE
CAS Number: 0061337-67-5
Other descriptive name: MIRTAZAPINE
Concentration unit: mg milligram(s
Sponsors
GGZ-Drenthe
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Male, non-smoking, between the ages of 18 and 35 years. 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 25 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Past or present sleeping disorder and/or psychiatric disorder, a family history of sleeping disorder and/or psychiatric disorder, liver disease, cardiovascular disease, alcohol- or substance dependance, medication use (including psychotropic medication), known intolerance for mirtazapine or quetiapine, a BMI of or below 18.5 or of or above 30.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to investigate the effect of low doses of mirtazapine and quetiapine on sleep, assessed using polysomnography and subjective sleep measures, of healthy subjects whose sleep will be disturbed by auditory stimuli (situational insomnia). ;Secondary Objective: The secondary objective of thist study is to examine hangover effects that may hamper daytime functioning, that is, daytime sleepiness and decreased cognitive functioning.;Primary end point(s): 1. Polysomnographically measured sleep * sleep latency * REM sleep latency * sleep continuity * sleep structure * relative sleep structure 2. Subjective sleep (questionnaire);Timepoint(s) of evaluation of this end point: Polysomnographs will be made eacht night. Subjective sleep will be evaluated after eacht third night, three times in total. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Daytime sleepiness (questionnaire and Slaap Latency Test) 2. Cognitive functioning (two cognitive tasks and Psychomotor Vigilance Task);Timepoint(s) of evaluation of this end point: Daytime sleepiness and cognitive functioning will be evaluated after each second night, three times in total. | — |
Countries
Netherlands
Contacts
Public ContactSenior Investigator
GGZ-Drenthe
Outcome results
None listed