BridgeMD
A randomized, double-blind, placebo-controlled, multicenter clinical trial to assess safety and effectiveness of Liposom in enhance and speed up response to antidepressant therapy with citalopram in elderly patients suffering from Major Depressive Disorder (MDD)
EU CTIS ID: 2024-512293-10-00
What this study is testing
The purpose of this study is to determine if Liposom Forte will enhance the response to antidepressant therapy with citalopram in elderly patients suffering from Major Depressive Disorder (MDD).
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Meets DSM-V criteria for major depressive disorder
- Score of ≥ 16 in the HAM-D
- Score of ≥ 23 on the Mini-Mental State Exam (MMSE-2)
- Aged ≥ 65 years
- Patients able to understand the study procedures and to comply with protocol requirements
- Patients legally able to give written informed consent to the trial (signed and dated by the subject)
You likely can't join if
- Any contraindication for treatment or intolerance to Liposom Forte or citalopram
- Treated with any antipsychotics, antidepressant, food supplements (St. John's Wort) or over-the-counter CNS-active medications within 2 weeks prior to the first administration of study medication, with the exception of MAOIs, for which the treatment is not permitted in the 3 weeks prior to the first administration of study medication
- Ongoing psychotherapy or other psychological treatment during the study period
- Congenital long QT syndrome, severe bradycardia, recent acute myocardial infarction, uncompensated heart failure or concomitant use of drugs that prolong the QT interval
- History of psychiatric disorder other than major depressive disorder, including history of substance use disorder
- Presence of psychotic symptoms, even if they are not sufficient to make diagnosis of a mental disorder
See the full eligibility criteria
- Meets DSM-V criteria for major depressive disorder
- Score of ≥ 16 in the HAM-D
- Score of ≥ 23 on the Mini-Mental State Exam (MMSE-2)
- Aged ≥ 65 years
- Patients able to understand the study procedures and to comply with protocol requirements
- Patients legally able to give written informed consent to the trial (signed and dated by the subject)
- Any contraindication for treatment or intolerance to Liposom Forte or citalopram
- Treated with any antipsychotics, antidepressant, food supplements (St. John's Wort) or over-the-counter CNS-active medications within 2 weeks prior to the first administration of study medication, with the exception of MAOIs, for which the treatment is not permitted in the 3 weeks prior to the first administration of study medication
- Ongoing psychotherapy or other psychological treatment during the study period
- Congenital long QT syndrome, severe bradycardia, recent acute myocardial infarction, uncompensated heart failure or concomitant use of drugs that prolong the QT interval
- History of psychiatric disorder other than major depressive disorder, including history of substance use disorder
- Presence of psychotic symptoms, even if they are not sufficient to make diagnosis of a mental disorder
- Severe uncompensated and/or acute organic disease or any other medical condition which may interfere with the aim of the study or with the subject health and well-being
- Major neurocognitive disorders (also called dementia)
- Diabetes Mellitus type I and II
- Acute suicidal or violent behaviour or history of suicide attempt within the year prior to study entry or current suicidal ideation
- Treated with long acting injectable (LAI) antipsychotics within 6 months prior to study entry
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.