Study on Dexamethasone for Patients with Moderate to Severe Depression: Evaluating Its Effectiveness with Mirtazapine, Citalopram, and Nortriptyline

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What is this study about?

The DEXA-PSYCH Study is focused on exploring new treatment options for people with moderate to severe depression. This study is investigating the use of dexamethasone, a medication typically used for its anti-inflammatory properties, to see if it can help improve symptoms of depression when added to the usual treatment. The study is designed to be a double-blind, randomized, and placebo-controlled trial, meaning that neither the participants nor the researchers know who is receiving the actual medication or a placebo, which is a pill with no active medication.

Participants in the study will continue their regular depression treatment while also taking either dexamethasone or a placebo for a short period. The study will monitor changes in depression symptoms and overall well-being over several weeks. The goal is to determine if dexamethasone can safely and effectively enhance the treatment of depression. The study will also look at various aspects of participants’ health, including any side effects, changes in mood, and quality of life.

In addition to dexamethasone, the study involves several other medications commonly used to treat depression, such as mirtazapine, citalopram, escitalopram, nortriptyline, sertraline, venlafaxine, lithium, and quetiapine. These medications are part of the usual treatment for depression and will be continued as prescribed by the participants’ healthcare providers. The study aims to provide valuable insights into how dexamethasone might be used alongside these treatments to improve outcomes for people with depression.

1 enrollment and initial assessment

Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes a diagnosis of moderate to severe depression and a score of 22 or above on the Montgomery-Asberg Depression Rating Scale (MADRS-10).

Participants must be between 18 and 64 years old, able to give informed consent, speak Danish fluently, and currently receiving treatment for depression.

2 baseline measurements

Baseline measurements will be taken on day 0. These include assessments of depression severity, quality of life, and other health indicators.

The MADRS-10 scale will be used to measure depression severity, and the EQ-5D-5L will assess quality of life.

3 medication administration

Participants will receive either dexamethasone or a placebo as an add-on to their usual treatment for depression. The medication is taken orally.

The specific dosage and frequency will be determined by the study protocol and communicated to participants during the trial.

4 follow-up assessments

Follow-up assessments will occur on days 4, 7, 14, and 28. These assessments will measure changes in depression severity, quality of life, and other health indicators.

The MADRS-10 and Hamilton Depression Rating Scale (HAM-D6 and HAM-D17) will be used to evaluate changes in depression symptoms.

5 safety monitoring

Safety will be monitored throughout the trial. This includes tracking any adverse reactions, changes in vital signs, and other health-related outcomes.

Participants will be asked about any side effects or changes in their health during each follow-up assessment.

6 final assessment and follow-up

A final assessment will be conducted at the end of the trial period, which is expected to last until day 28.

Participants will also have a follow-up assessment at 6 months to evaluate long-term outcomes, including changes in depression symptoms and quality of life.

Who Can Join the Study?

Have a diagnosis of non-psychotic, moderate to severe depressive disorder (either a single episode or recurrent) confirmed by a medical doctor.
Have a score of 22 or above on the MADRS10 scale at the start of the study. The MADRS10 scale is a tool used to measure the severity of depression symptoms.
Be between the ages of 18 and 64 years old at the time of joining the study.
Be habile, meaning able to give informed consent, which is the ability to understand the study and agree to participate.
Speak Danish fluently.
Currently receiving medication for depression.

Who Cannot Join the Study?

Patients who are not diagnosed with moderate to severe depression cannot participate.
Patients who are not within the specified age range for the study cannot participate. (The specific age range is not provided here.)
Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Region Hovedstadens Psykiatriske	Glostrup	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	17.10.2022

Trial locations

Investigated drugs:

Dexamethasone is a medication that is being tested in this clinical trial to see if it can help people with moderate to severe depression. It is usually used to reduce inflammation in the body, but in this study, researchers want to find out if it can also improve symptoms of depression when added to the usual treatments that patients are already receiving. Dexamethasone is known to be well-tolerated, which means that most people can take it without experiencing serious side effects. The goal of the trial is to determine if adding dexamethasone to the current treatment can make a positive difference in managing depression.

Investigated diseases:

Depression

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 often involves changes in sleep, appetite, and energy levels, as well as difficulties in concentration and decision-making. The disorder can lead to physical symptoms such as fatigue and aches, and it may cause individuals to withdraw from social interactions. Over time, these symptoms can become more severe and interfere significantly with daily functioning. The progression of the disorder varies, with some individuals experiencing episodes that last for weeks or months, while others may have recurrent episodes throughout their lives.

Trial ID:

2022-501428-45-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Dexamethasone for Patients with Moderate to Severe Depression: Evaluating Its Effectiveness with Mirtazapine, Citalopram, and Nortriptyline

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?