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Amitriptyline Hydrochloride

Clinical trials investigating Amitriptyline Hydrochloride are studying how it performs in real patients with different conditions. These studies look at outcomes such as symptom improvement, treatment success, and safe stopping of therapy in people with insomnia, migraine, and depressive disorders.

Table of contents

Trial overview

The trial data show that Amitriptyline Hydrochloride is being studied in different patient groups, not as a general drug description but as a research treatment in specific clinical settings.[1][2][3][4][5]

Across the studies, the main conditions are insomnia, migraine, and depressive disorder, including people whose depression is currently remitted, which means symptoms have improved or are absent.[1][3][4][5]

Most of the listed studies are Phase 3 trials, which usually means the treatment is being tested in larger groups and compared with another approach or usual care.[2][3][4][5]

Insomnia study

The TIMELAPSE study was completed and included 190 participants with chronic insomnia and medical conditions.[1]

This study looked at whether low-dose Amitriptyline Hydrochloride, given as 10 to 20 mg, was as effective as CBT-I, which means cognitive behavioral therapy for insomnia.[1]

The main outcome was the mean subjective insomnia severity score, measured with the Insomnia Severity Index (ISI) at 12 weeks.[1]

This tells patients that the study focused on how people felt about their sleep problems, not only on medical test results.[1]

Depression studies

Several studies are looking at Amitriptyline Hydrochloride in depression-related care, but each study has a different question.[2][4][5]

In NCT05973851, adults with major depressive disorder and a first-time treatment failure are being studied in a Phase 3 trial with 453 participants.[2]

This study compares early intensified pharmacological treatment with treatment as usual, and Amitriptyline is one of the medicines included in the treatment options.[2]

The main outcome is the change in depression severity measured by the MADRS, the Montgomery Åsberg Depression Rating Scale, at six weeks.[2]

In 2025-522967-13-00, researchers are testing a pre-emptive pharmacogenetic strategy, meaning they use genetic information before choosing treatment, in people with depressive disorder who are starting a new antidepressant after prior treatment failure.[5]

This Phase 3 trial includes 240 participants and measures symptom remission using changes in PHQ-9 and MADRS scores.[5]

The trial includes Amitriptyline Hydrochloride among several antidepressant choices, so the research is about treatment selection rather than only one medicine alone.[5]

Migraine study

NCT06499116 is a Phase 3 study in 460 people with migraine in primary care.[3]

The study compares several preventive treatments, including Amitriptyline Hydrochloride, flunarizine, topiramate, and propranolol.[3]

The main outcome is the change in the mean number of monthly migraine days (MMD) after 12 weeks of treatment.[3]

This outcome helps show whether treatment lowers how often migraine happens during a month.[3]

Stopping antidepressants safely

The DISCARD study, NCT2023-509377-23-00, is a Phase 3 trial in 150 people with currently remitted depressive disorders.[4]

This study compares hyperbolic tapering with linear tapering, which are two different ways of slowly lowering a medicine dose before stopping it.[4]

Amitriptyline Hydrochloride appears in the study drug list as Laroxyl, and the trial measures whether participants can stop the antidepressant without needing to restart it during the 16 weeks after discontinuation.[4]

The main outcome also includes people who cannot finish the planned tapering schedule, which may happen because of withdrawal symptoms or a return of depressive or anxiety symptoms.[4]

What the trial outcomes mean

These studies use patient-centered outcomes, which means they focus on how the person feels and functions in daily life.[1][2][3][4][5]

For insomnia, the outcome is a score that reflects how severe sleep problems feel to the participant.[1]

For depression, the studies use rating scales such as MADRS and PHQ-9 to track symptom change and remission.[2][5]

For migraine, the main measure is the number of migraine days in a month, which is a simple way to track prevention success.[3]

For antidepressant stopping studies, the outcome is whether the person can complete tapering and stay off the medicine for the follow-up period.[4]

Who may participate

The trial data suggest that participation depends on the condition being studied and the stage of illness.[1][2][3][4][5]

  • People with chronic insomnia and medical conditions were included in the TIMELAPSE study.[1]
  • People with major depressive disorder who had a first-time treatment failure were included in the intensified treatment study.[2]
  • People with migraine in primary care were included in the preventive treatment study.[3]
  • People with currently remitted depressive disorders were included in the antidepressant discontinuation study.[4]
  • People with depressive disorder starting a new antidepressant after prior treatment failure were included in the pharmacogenetic study.[5]
Trial ID Phase Condition studied Status Enrollment
2024-518320-71-00 Low Intervention Insomnia Completed 190
NCT05973851 Phase 3 Major depressive disorder Authorised 453
NCT06499116 Phase 3 Migraine Authorised 460
2023-509377-23-00 Phase 3 Remitted depressive disorders Authorised 150
2025-522967-13-00 Phase 3 Depressive disorder Authorised 240

FAQ

  • Who can join clinical trials of Amitriptyline Hydrochloride? It depends on the study. The trials in the data include adults with chronic insomnia, migraine, major depressive disorder, and people with remitted depressive disorders or depressive disorder after treatment failure.
  • What are the trials of Amitriptyline Hydrochloride trying to find out? They are testing how well Amitriptyline Hydrochloride works in specific patient groups. The studies measure results such as fewer insomnia symptoms, fewer migraine days, better depression scores, and whether antidepressants can be stopped safely.
  • What phases are these trials in? The trials are mainly Phase 3 studies, which usually compare treatments in larger groups of patients. One study is listed as Low Intervention.
  • Which conditions are being studied? The studies focus on insomnia, migraine, major depressive disorder, and depressive disorder, including patients whose depression has improved or who had a first treatment failure.
  • What results are measured in these trials? The trials measure patient-reported sleep severity, monthly migraine days, depression rating scales, and whether people can discontinue antidepressant treatment without restarting it.

Ongoing Clinical Trials on Amitriptyline Hydrochloride

  • Study Comparing Amitriptyline, Flunarizine, Topiramate, and Propranolol for Preventing Migraines in Primary Care Patients

    Recruiting

    1 1 1 1
    Investigated drugs:
    Spain

  • Study on the Effect of Ketamine and Esketamine in Patients with Major Depressive Disorder After First-Line Treatment Failure

    Recruiting

    1 1 1 1
    Investigated drugs:
    Austria Germany Greece Italy Spain

  • Safe Discontinuation of Antidepressants in Patients with Remitted Depression: Amitriptyline, Fluoxetine, Paroxetine, and Drug Combination Study

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

  • Testing a Pharmacogenetic-Guided Treatment Selection Strategy with Antidepressant Drug Combination for Patients with Depressive Disorder

    Not yet recruiting

    1 1 1 1
    Investigated drugs:
    Spain

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

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

Glossary

  • Clinical trial: A research study in people that tests a treatment, compares treatments, or checks how well a treatment works in a real-world setting.
  • Interventional study: A study where researchers give a treatment or compare treatments and then measure the results.
  • Phase 3: A later stage of clinical research that usually includes more people and compares how well treatments work.
  • Low Intervention: A study with limited added research procedures, often closer to usual care.
  • Enrollment: The number of participants planned or included in a study.
  • Primary outcome: The main result the researchers want to measure.
  • Insomnia Severity Index (ISI): A questionnaire that measures how serious insomnia symptoms are.
  • Montgomery Åsberg Depression Rating Scale (MADRS): A score used to measure how severe depression symptoms are.
  • PHQ-9: A short questionnaire used to measure depression symptoms.
  • Monthly migraine days (MMD): The number of days in a month when a person has migraine.
  • Tapering: Slowly lowering a medicine dose over time instead of stopping suddenly.

References