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Study on the Effectiveness of Hypothalamic Phospholipids and Citalopram for Treating Major Depressive Disorder in Elderly Patients

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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 studying the effects of a treatment for Major Depressive Disorder in elderly patients. The study involves the use of a medication called Liposom Forte, which contains hypothalamic phospholipids, and is administered as a solution for injection. The trial also includes the use of citalopram, a commonly prescribed antidepressant, in the form of film-coated tablets. Additionally, a placebo is used in the study to help assess the effectiveness of the treatment.

The purpose of the study is to determine if Liposom Forte can enhance and speed up the response to antidepressant therapy with citalopram in elderly patients suffering from Major Depressive Disorder. Participants in the study will receive either the active treatment or a placebo, and their progress will be monitored over a period of time. The study is designed to be double-blind, meaning neither the participants nor the researchers know who is receiving the active treatment or the placebo, to ensure unbiased results.

Throughout the study, participants will have regular visits to assess their response to the treatment. The effectiveness of the treatment will be evaluated by measuring changes in depressive symptoms using established scales. The study will also monitor the safety of the treatments by tracking any side effects or changes in health indicators. The trial aims to provide valuable information on whether Liposom Forte can improve the effectiveness of citalopram in treating depression in the elderly.

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 meeting the criteria for Major Depressive Disorder and being aged 65 or older.
The assessment involves a mental health evaluation using the Hamilton Rating Scale for Depression and the Mini-Mental State Exam.
Step 2
Randomization and treatment allocation
Participants are randomly assigned to receive either Liposom Forte, Citalopram, or a placebo.
Liposom Forte is administered as a 28 mg/2 ml solution for injection, while Citalopram is given as a 20 mg film-coated tablet.
Step 3
Treatment phase
The treatment phase involves regular administration of the assigned medication. Liposom Forte is given via intramuscular injection, and Citalopram is taken orally.
The duration of this phase is up to 90 days, with regular monitoring and assessments at specified intervals.
Step 4
Follow-up visits
Follow-up visits occur at multiple points: Visit 2 (Day 7), Visit 3 (Day 14), Visit 4 (Day 21), and Visit 5 (Day 30).
During these visits, the improvement of depressive symptoms is evaluated using the Hamilton Rating Scale for Depression and the Geriatric Depression Scale.
Step 5
Final evaluation
The final evaluation takes place at Visit 8 (Day 90).
This includes a comprehensive assessment of depressive symptoms, overall clinical impression, and safety of the treatments through ECG and vital signs measurements.

Who can join the trial?

7 criteria

The patient must have a condition called Major Depressive Disorder, which is a type of depression.
The patient must meet the DSM-V criteria for major depressive disorder. This means their symptoms match a specific list used by doctors to diagnose depression.
The patient must have a score of 16 or higher on the HAM-D, which is a questionnaire used to measure the severity of depression.
The patient must have a score of 23 or higher on the Mini-Mental State Exam (MMSE-2), which is a test that checks mental functions like memory and understanding.
The patient must be aged 65 years or older.
The patient must be able to understand the study procedures and follow the study rules.
The patient must be legally able to give written informed consent, meaning they can sign and date a form agreeing to participate in the study.

Who cannot join the trial?

4 criteria

Patients who do not have Major Depressive Disorder (a mental health condition causing persistent sadness and loss of interest) cannot participate.
Patients who are not elderly cannot participate, as the study focuses on older adults.
Patients who are not taking citalopram (a medication used to treat depression) cannot participate.
Patients who are part of a vulnerable population, such as those unable to give consent, cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

ASST Fatebenefratelli Sacco
Verified
Milan, Italy
Azienda Ospedaliero-Universitaria Sant Andre
Responsive
Rome, Italy

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Investigated drugs

Liposom Forte
is being studied to see if it can improve the effects of antidepressant treatment in elderly patients with Major Depressive Disorder. It is used in combination with another medication to potentially enhance the overall response to treatment.
Citalopram
is an antidepressant medication that is commonly used to treat Major Depressive Disorder. In this trial, it is being used as the primary treatment for depression, and researchers are investigating whether its effectiveness can be increased when used alongside Liposom Forte.

What is already known about the treatment

Liposom Forte – This medication is administered orally and is currently being studied in clinical trials to evaluate its effectiveness in enhancing the response to antidepressant therapy with citalopram in elderly patients with Major Depressive Disorder. It is not yet widely recognized in medical literature as a standard treatment. The main therapeutic indication is to improve the speed and effectiveness of antidepressant therapy. Liposom Forte works at the molecular level by potentially enhancing the delivery and absorption of citalopram, thereby increasing its efficacy. It is classified pharmacologically as an adjunctive therapy to antidepressants.

Investigated diseases

Major Depressive Disorder – This is a mental health condition characterized by persistent feelings of sadness, loss of interest in activities, and a range of emotional and physical problems. In elderly patients, it may manifest with symptoms such as fatigue, changes in appetite, sleep disturbances, and difficulty concentrating. The disorder can lead to significant impairment in daily functioning and quality of life. It often progresses with episodes that can vary in duration and intensity. The condition may be influenced by various factors, including biological, psychological, and social elements. Understanding and managing these symptoms is crucial for improving the well-being of those affected.