Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Sleep is an essential requirement for life, and is vital for people to be able to function. Many people in the general population have trouble falling or staying asleep, or do not feel refreshed after sleeping. Around 30% of otherwise healthy people experience these kinds of sleep difficulties (insomnia) and in those suffering from mental health problems, this number is even higher. Insomnia is often treated using sedatives (benzodiazepines), however these are very addictive and can have unwanted side effects, such as feeling tired and sleepy during the day. In many cases, low doses of alternative drugs which have sedating properties are prescribed, such as mirtazapine (antidepressant), or quetiapine (antipsychotic medication). Although many doctors observe improvement in patients treated this way, there are few studies which support the effectiveness of low doses of mirtazapine or quetiapine for the treatment of insomnia. The aim of this study is to investigate the effects of 7.5mg mirtazapine and 50mg quetiapine on sleep and daytime functioning.

Who can participate?
Healthy men aged between 18 and 35 who usually go to bed between 10pm and midnight and sleep between 6.5 to 8.5 hours a night.

What does the study involve?
Participants sleep at the sleep center of GGZ Drenthe on three consecutive nights, for three consecutive weeks. Each week participants take a different medication, the order of which is random. Night one of each week is considered an adaptation night, when participants can adapt to sleeping in the unfamiliar surroundings. On nights two and three of each week, participants are asked to take a capsule containing 7.5mg mirtazapine, 50mg quetiapine, or a placebo (dummy pill) 30 minutes before they go to bed. During the night, participants have their sleep monitored by a machine that records brain waves, blood oxygen levels, heart rate, breathing and eye and leg movement (polysomnography). Each morning, participants are asked to fill out questionnaires about their quality of sleep and current sleepiness and complete tasks on a computer which measure their reaction time (movement associated with mental processes).

What are the possible benefits and risks of participating?
There are no direct benefits of taking part although participants will receive financial compensation. There is a small risk of experiencing side effects from the study medications, such as sleepiness during the day or dizziness.

Where is the study run from?
GGZ Drenthe (Netherlands)

When is the study starting and how long is it expected to run for?
January 2014 to September 2015

Who is funding the study?
GGZ Drenthe (Netherlands)

Who is the main contact?
Dr Julie Karsten

Trial website

Contact information



Primary contact

Dr Julie Karsten


Contact details

GGZ Drenthe
Dennenweg 9
9404 LA

Additional identifiers

EudraCT number

2013-003460-31 number

Protocol/serial number


Study information

Scientific title

The effect of 7.5 mg mirtazapine and 50 mg quetiapine, compared to placebo, on situational insomnia and daytime functioning in healthy male subjects


Study hypothesis

7.5 mg mirtazapine or 50 mg quetiapine improve situational insomnia, without affecting daytime functioning.

Ethics approval

Regional ethics board METC Isala Zwolle, 03/03/2014, ref: 13.11138

Study design

Single-centre double blind cross-over study

Primary study design


Secondary study design

Randomised cross over trial

Trial setting


Trial type


Patient information sheet

No participant information sheet available




Participants attend the study centre on consecutive nights, for three consecutive weeks and receive the study treatments in a random order. The first night of the study is an adaption night and the study medication is taken 30 minutes before bed on the second and third night. During sleep, participants are monitored using polysomnography. Participants are interviewed 15 minutes and two hours after waking to assess sleep quality and daytime sleepiness.

Study treatments:
7.5 mg mirtazapine
50 mg quetiapine

Intervention type



Not Applicable

Drug names

1. Mirtazapine
2. Quetiapine

Primary outcome measures

1. Sleep quality is measured using polysomnography during each night
2. Subjective sleep is measured by the Leeds Sleep Evaluation Questionnaire (LSEQ) 15 minutes after waking

Secondary outcome measures

1. Daytime sleepiness is measured by the Karolinska Sleepiness Scale (KSS) 2 hours after waking
2. Daytime cognitive functioning is measured by the Psychomotor Vigilance Task (PVT) and the Digit Symbol Substitution Task (DSST) 2 hours after waking

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Male
2. Aged between 18-35 years
3. BMI between 18.0-30 kg/m2
4. Absence of clinically relevant health problems
5. History of going to bed from 22.00h to 00.00h on at least 5-7 nights per week, with a reported sleep duration of 6.5-8.5h over the previous 3 months before the start of and during the study

Participant type

Healthy volunteer

Age group




Target number of participants


Participant exclusion criteria

1. History of sleep disorder or psychiatric illness
2. Family history of sleep disorder or psychiatric disorder
3. Liver disease
4. Cardiovascular disease
5. Alcohol or drug dependence
6. Use of (psychotropic) medication
7. Known intolerance for either mirtazapine or quetiapine

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

GGZ Drenthe
Dennenweg 9
9404 LA

Sponsor information


GGZ Drenthe

Sponsor details

Dennenweg 9
9404 LA

Sponsor type

Hospital/treatment centre



Funder type


Funder name

GGZ Drenthe

Alternative name(s)

Geestelijke Gezondheidszorg Drenthe

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit



Results and Publications

Publication and dissemination plan

1. Planned publication of study results in a peer reviewed journal
2. Planned dissemination of findings at national and international conferences

Intention to publish date


Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes