Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study on Amitriptyline and Cognitive Behavioral Therapy for Patients with Chronic Insomnia and Medical Conditions

Registered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effectiveness of a medication called amitriptyline hydrochloride in treating chronic insomnia, which is a condition where individuals have trouble sleeping for at least three nights a week over a period of three months or more. The study also considers patients who have other medical conditions alongside insomnia. The medication being tested is a low dose of amitriptyline, which is commonly used to treat depression but is being evaluated here for its potential benefits in improving sleep.

The purpose of the study is to determine if low dose amitriptyline is as effective as cognitive behavioral therapy for insomnia (CBT-I), a type of therapy that helps people change their thoughts and behaviors around sleep. Participants in the study will either receive the medication or undergo CBT-I. The study will last for a period of 12 weeks, during which the participants' sleep patterns and daytime functioning will be monitored to assess the effectiveness of the treatment.

Throughout the study, researchers will collect information on how well participants sleep, their overall sleep quality, and how they function during the day. They will also monitor any side effects or withdrawal symptoms from the treatment. The goal is to see if amitriptyline can be a viable alternative to CBT-I for people with chronic insomnia and other medical conditions.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, participants will be informed about the purpose and procedures of the trial. The study aims to compare the effectiveness of low dose amitriptyline with cognitive behavioral therapy for improving sleep in individuals with chronic insomnia and other medical conditions.

  2. Step 2

    Initial assessment

    Participants will undergo an initial assessment to confirm eligibility. This includes verifying the presence of insomnia, which involves sleep problems at least 3 nights a week for at least 3 months, and a score of 10 or more on the Insomnia Severity Index (ISI).

  3. Step 3

    Medication administration

    Participants will receive a low dose of amitriptyline in the form of a film-coated tablet. The dosage will be between 10 mg and 20 mg, taken orally. The exact dosage and frequency will be determined by the study protocol and communicated to the participant.

  4. Step 4

    Treatment duration

    The treatment with amitriptyline will continue for a period of 12 weeks. During this time, participants will be required to adhere to the medication schedule as instructed.

  5. Step 5

    Monitoring and evaluation

    Throughout the trial, participants will be monitored for changes in sleep quality and daytime functioning. This includes keeping a sleep diary to record sleep patterns and any side effects experienced. The primary focus will be on the mean subjective insomnia severity score measured by the ISI at 12 weeks.

  6. Step 6

    Completion of the trial

    At the end of the 12-week period, participants will undergo a final assessment to evaluate the effectiveness of the treatment. This will include reviewing sleep quality, daytime functioning, and any adverse events or withdrawal symptoms.

Who can join the trial?

4 criteria

  • Adults aged 18 to 85 years old.
  • Have insomnia disorder according to DSM-5, which means having sleep problems at least 3 nights a week for at least 3 months, with effects on daytime activities. The sleep problem should not be better explained by another sleep disorder, like sleep-related breathing disorder or parasomnia.
  • Score of 10 or more on the Insomnia Severity Index (ISI), a questionnaire that measures the severity of insomnia.
  • Have a medical condition and/or chronic pain lasting more than 3 months.

Who cannot join the trial?

3 criteria

  • Patients who are not experiencing chronic insomnia cannot participate. Chronic insomnia means having trouble sleeping for a long time.
  • Patients who are not within the specified age range cannot participate. The study is open to adults and older adults.
  • Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups like children, pregnant women, or those unable to give consent.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Amitriptyline

    is a medication that is often used to treat depression, but in this trial, it is being used in a low dose to help people with chronic insomnia. Insomnia is a condition where people have trouble sleeping. Amitriptyline can help improve sleep by making you feel more relaxed and sleepy. It is being tested to see if it can help people sleep better when they also have other medical conditions.

  • Cognitive Behavioral Therapy for Insomnia (CBT-I)

    is a type of talk therapy that helps people change the way they think and behave about sleep. It teaches new habits and ways to relax, which can help improve sleep over time. In this trial, CBT-I is being compared to low dose amitriptyline to see which one is more effective in helping people with chronic insomnia and other medical conditions sleep better.

What is already known about the treatment

Amitriptyline – Amitriptyline is a medication taken orally, usually in the form of a tablet, and is used to help people with chronic insomnia, especially when it occurs alongside other medical conditions. It is currently being studied to see if it is as effective as cognitive behavioral therapy for insomnia (CBT-I) in improving sleep quality. Amitriptyline works by affecting certain chemicals in the brain that may be unbalanced in people with sleep problems. It belongs to a group of medications known as tricyclic antidepressants, which are often used to treat depression but can also help with sleep issues.

Investigated diseases

Insomnia – Insomnia is a sleep disorder characterized by difficulty falling asleep, staying asleep, or waking up too early and not being able to return to sleep. It can lead to poor sleep quality and insufficient rest, affecting daily functioning. The condition can be acute, lasting a few days or weeks, or chronic, persisting for a month or longer. Insomnia can be associated with stress, anxiety, depression, or other medical conditions. Over time, it may result in fatigue, mood disturbances, and impaired concentration. The disorder can vary in severity and may fluctuate over time.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-518320-71-00Protocol codeMP-2019-001Estimated enrolment190 patientsSponsorZiekenhuis Gelderse Vallei Stichting

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.