Not recruiting

Study on Stopping Antidepressants: Comparing Tapering Methods for Patients with Major Depressive Disorder Using Venlafaxine or Paroxetine Hydrochloride

Verified siteRegistered drugNo placebo

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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 with Major Depressive Disorder (MDD), a condition characterized by persistent feelings of sadness and loss of interest. The study is examining the best ways to stop using certain antidepressants, specifically Venlafaxine and Paroxetine Hydrochloride. These medications are commonly used to treat depression, and the trial aims to find effective methods for discontinuing their use in patients who have been stable and in remission from MDD for a significant period.

The purpose of the study is to compare two different strategies for tapering off these antidepressants. Participants will be randomly assigned to one of the two strategies, and some may receive a placebo. The trial will be conducted in a double-blind manner, meaning neither the participants nor the researchers will know who is receiving which treatment. This approach helps ensure the results are unbiased and reliable.

The study will last for several months, during which participants will gradually reduce their medication under close supervision. The main focus will be on the rate of failure to successfully discontinue the antidepressant, which includes any significant withdrawal symptoms or the need to switch to another medication. The trial will help determine the most effective and safe way to stop using these medications for those who have achieved remission from MDD.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age between 18-75 years and stable remission of major depressive disorder (MDD) for at least six months, or one year in recurrent cases.
A score of 12 or lower on the Patient Health Questionnaire 9 (PHQ-9) is required, along with confirmation of a previous MDD episode and current remission through a semi-structured psychiatric interview.
Step 2
Medication regimen
Participants must be using either paroxetine (20-50 mg) or venlafaxine (75-375 mg) at the start of the trial. These medications are taken orally.
The trial aims to compare two tapering strategies for discontinuing these antidepressants.
Step 3
Phase I: tapering strategy
Participants are randomly assigned to one of two tapering strategies. This phase involves gradually reducing the dosage of the antidepressant over a specified period.
The goal is to minimize withdrawal symptoms and assess the effectiveness of each strategy.
Step 4
Phase II: monitoring
During this phase, participants are closely monitored for any withdrawal symptoms or deviations from the discontinuation protocol.
Significant withdrawal symptoms are defined as an increase in the modified 15-item Discontinuation-Emergent Signs and Symptoms (DESS) scale from baseline by four or more points for two consecutive assessments.
Step 5
Completion and evaluation
The trial concludes with an evaluation of the rate of failure to successfully discontinue the antidepressant.
This is determined by any significant deviation from the discontinuation protocol or the need for rescue medication for five or more days in total.

Who can join the trial?

5 criteria

Age between 18 and 75 years.
Have a stable remission of **Major Depressive Disorder (MDD)** for at least 6 months, or at least 1 year if MDD has occurred more than once. This should be confirmed with a score of 12 or lower on the **Patient Health Questionnaire 9 (PHQ-9)**, which is a tool used to measure depression levels.
Currently using either **paroxetine** (20-50mg) or **venlafaxine** (75-375mg), which are types of antidepressant medications.
Have had a previous episode of MDD and are currently in remission, confirmed with a **semi-structured psychiatric interview (MINI)**, which is a type of interview used by doctors to assess mental health conditions.
Willing and able to provide **informed consent**, meaning you understand the study and agree to participate, and can follow the procedures necessary to be part of the study.

Who cannot join the trial?

5 criteria

Patients who are not diagnosed with Major Depressive Disorder (a mental health condition characterized by persistent feelings of sadness and loss of interest).
Patients who are not in a stable and remitted state of their depression (meaning their symptoms are not currently severe or active).
Patients who are not using either PAR (Paroxetine, a type of antidepressant) or VLX (Venlafaxine, another type of antidepressant).
Patients who are younger than 18 years old or older than 65 years old.
Patients who belong to a vulnerable population (groups that may need special protection, such as children or those unable to give consent).

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Verified sites

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Amsterdam UMC
Responsive
Amsterdam, The Netherlands
Stichting Radboud University Medical Center
Responsive
Nijmegen, The Netherlands

Trial locations

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Investigated drugs

PAR
is an antidepressant medication used in the trial to help patients with major depressive disorder (MDD) who are in stable remission. The trial aims to find the best way to discontinue this medication safely and effectively.
VLX
is another antidepressant medication involved in the trial. Like PAR, it is used for patients with stable remitted major depressive disorder. The study seeks to determine the most effective method for tapering off this medication.

What is already known about the treatment

Paroxetine
Paroxetine is typically administered orally in the form of tablets or liquid. It is widely recognized in medical literature as an effective treatment for Major Depressive Disorder (MDD). The medication works by increasing the levels of serotonin, a neurotransmitter, in the brain, which helps improve mood and reduce symptoms of depression. Paroxetine belongs to the pharmacological class of selective serotonin reuptake inhibitors (SSRIs).
Venlafaxine
Venlafaxine is usually taken orally as tablets or extended-release capsules. It is well-documented in medical literature for its use in treating Major Depressive Disorder (MDD). The drug functions by increasing the levels of serotonin and norepinephrine, neurotransmitters that play a key role in mood regulation. Venlafaxine is classified as a serotonin-norepinephrine reuptake inhibitor (SNRI).

Investigated diseases

Major Depressive Disorder – Major Depressive Disorder (MDD) is a mental health condition characterized by persistent feelings of sadness, hopelessness, and a lack of interest or pleasure in most activities. Individuals with MDD may experience changes in appetite, sleep disturbances, fatigue, and difficulty concentrating. The disorder can lead to significant impairment in daily functioning and relationships. Symptoms can vary in intensity and duration, often occurring in episodes that may last weeks or months. MDD is a common condition that can affect people of all ages and backgrounds. It is important to recognize that MDD is a medical condition that requires understanding and support.