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

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What is this trial about?

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

This clinical trial is focused on individuals who have been diagnosed with depressive disorders and are currently in remission, meaning their symptoms have improved significantly. The study aims to explore the best way to safely stop taking antidepressants for those who no longer need them. The medications being studied include amitriptyline hydrochloride, fluoxetine hydrochloride, paroxetine, escitalopram oxalate, citalopram hydrochloride, vortioxetine (also known as AA21004), sertraline, and venlafaxine hydrochloride. These medications are commonly used to treat depression and are taken orally in the form of drops or solutions.

The purpose of the study is to compare two different methods of gradually reducing the dose of these medications to see which one is more effective in helping patients stop their medication without experiencing a return of their depression symptoms. Participants will follow a specific schedule to slowly decrease their medication over a period of time. The study will monitor how many participants are able to successfully stop their medication and how many need to restart it within 16 weeks after stopping.

Throughout the study, participants will be observed for any withdrawal symptoms, which are physical or emotional symptoms that can occur when stopping a medication. The study will also track any signs of depression or anxiety returning. The goal is to find a safe and effective way to discontinue antidepressants for those who are ready to stop taking them. Participants will be supported by healthcare professionals throughout the process to ensure their safety and well-being.

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

    Enrollment

    Upon joining the study, you will be asked to sign an informed consent form. This document confirms your willingness to participate and ensures you understand the study's purpose and procedures.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm your eligibility. This includes verifying that you have a remitted depressive disorder and are currently taking a stable dose of an antidepressant for at least six months.

  3. Step 3

    Tapering phase

    You will begin the tapering phase, where your current antidepressant dosage will be gradually reduced. This process will follow either a hyperbolic or linear tapering schedule, as determined by the study protocol.

    The tapering schedule is designed to safely reduce your medication over a pre-defined period, with a tolerance period of no more than 15% of the total duration.

  4. Step 4

    Medication details

    The medications involved in the study include: amitriptyline hydrochloride, fluoxetine hydrochloride, paroxetine, escitalopram oxalate, citalopram hydrochloride, vortioxetine, sertraline, and venlafaxine hydrochloride. All are administered orally in the form of drops or solutions.

  5. Step 5

    Monitoring and follow-up

    Throughout the tapering phase and for 16 weeks after discontinuation, you will be monitored for any withdrawal symptoms or recurrence of depressive symptoms.

    Regular follow-up visits will be scheduled to assess your progress and address any concerns.

  6. Step 6

    Completion

    At the end of the study, your participation will be evaluated based on the ability to discontinue the antidepressant and any need to restart it during the follow-up period.

    The study aims to determine the most effective tapering strategy for safely discontinuing antidepressants in individuals with remitted depressive disorders.

Who can join the trial?

11 criteria

  • Must be 18 years old or above.
  • There is uncertainty about which method to stop taking the medication would be best for you.
  • You are willing to sign a form agreeing to participate in the study.
  • Have been diagnosed with a depressive disorder, either a single episode or recurrent.
  • Currently taking one of the following medications for depression: SSRI (Selective Serotonin Reuptake Inhibitor), SNRI (Serotonin and Norepinephrine Reuptake Inhibitor), TCA (Tricyclic Antidepressant), or vortioxetine.
  • The current medication has been taken for at least 6 months.
  • The current medication has been on a stable dose for the last 2 months.
  • A score of 9 or less on the PHQ-9 questionnaire and 5 or less on the GAD-7 questionnaire at the time of joining the study.
  • Do not meet the criteria for a depressive episode according to the DSM-5-TR at the time of joining the study.
  • No clinical evidence of moderate-to-severe symptoms in the last 6 months, as assessed by the doctor.
  • Stopping the medication is considered clinically appropriate by the doctor, and you agree to it through a shared decision-making process.

Who cannot join the trial?

1 criterion

  • Patients who currently have their depressive disorders under control and are not experiencing symptoms cannot participate.
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Investigated drugs

Antidepressants are medications used to help improve mood and relieve symptoms of depression. In this clinical trial, participants who have depression that is currently under control will be gradually reducing their use of antidepressants. The study aims to find the best way to stop taking these medications safely, without causing the depression to return. The trial will compare two different methods of reducing the medication: one method involves slowly decreasing the dose in a straight line, while the other method involves a more gradual reduction that slows down even more as the dose gets smaller. The goal is to see which method helps people stop taking the medication without their depression coming back.

What is already known about the treatment

Antidepressants – Antidepressants are typically administered orally in the form of tablets or capsules. They are widely used in medicine to treat depressive disorders and are well-documented in medical literature. The main therapeutic indication for antidepressants is to alleviate symptoms of depression. At the molecular level, they work by balancing chemicals in the brain, such as serotonin, norepinephrine, and dopamine, which are linked to mood and emotional state. Antidepressants are classified pharmacologically as psychotropic medications, specifically within the category of mood stabilizers.

Investigated diseases

Major Depressive Disorder – Major Depressive Disorder is a mental health condition characterized by persistent feelings of sadness, hopelessness, and a lack of interest or pleasure in activities. It can lead to a variety of emotional and physical problems, affecting a person's ability to function in daily life. The disorder often progresses with episodes that can last for weeks or months, during which symptoms may intensify. Individuals may experience changes in appetite, sleep disturbances, fatigue, and difficulty concentrating. The progression can vary, with some experiencing recurrent episodes, while others may have a single episode. The disorder can also be accompanied by anxiety symptoms, which may complicate the course of the illness.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509377-23-00Protocol codeDISCARDEstimated enrolment150 patientsSponsorUniversita Degli Studi Di Verona

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