The effect of low doses of mirtazapine and quetiapine on sleep and daytime functioning
| ISRCTN | ISRCTN20011041 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20011041 |
| EudraCT/CTIS number | 2013-003460-31 |
| Secondary identifying numbers | NL46501.075.13 |
- Submission date
- 30/03/2016
- Registration date
- 31/03/2016
- Last edited
- 29/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
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
Contact information
Scientific
GGZ Drenthe
Dennenweg 9
Assen
9404 LA
Netherlands
Study information
| Study design | Single-centre double blind cross-over study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| 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(s) | Regional ethics board METC Isala Zwolle, 03/03/2014, ref: 13.11138 |
| Condition | Insomnia |
| Intervention | 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 Placebo |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 1. Mirtazapine 2. Quetiapine |
| Primary outcome measure | 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 study start date | 01/01/2014 |
| Overall study end date | 02/09/2015 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 35 Years |
| Sex | Male |
| Target number of participants | 19 |
| 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 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 | 01/09/2014 |
| Recruitment end date | 01/05/2015 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Assen
9404 LA
Netherlands
Sponsor information
Hospital/treatment centre
Dennenweg 9
Assen
9404 LA
Netherlands
"ROR" |
https://ror.org/0107rkg57 |
|---|
Funders
Funder type
Industry
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Geestelijke Gezondheidszorg Drenthe
- Location
- Netherlands
Results and Publications
| Intention to publish date | 01/09/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| 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 |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2017 | 29/01/2019 | Yes | No |
Editorial Notes
29/01/2019: Publication reference added
