BridgeMD
A research study to compare the antidepressant ability and safety of Samyr® tablets versus placebo tablets as an adjunct to additional antidepressant treatment in patients with major depressive disorder (MDD)
EU CTIS ID: 2024-513019-29-00
What this study is testing
To demonstrate that in participants with MDD with inadequate response to antidepressants and Hamilton score of 15-20 (with up to 10% reduction at baseline) Samyr® is superior to placebo tablet, when used along with an adjunctive antidepressant therapy following six weeks of treatment based on HDRS-17 score.
- Therapeutic confirmatory (Phase III)
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
- Written and signed informed consent needs to be provided by participants before starting any protocol-specific procedures.
- Male and female participants between the ages of 18 to 65 years, both ages inclusive.
- Participant who is able and willing to comply with the requirements of the study protocol including the visits scheme, assessments and scales.
- Primary diagnosis of MDD of at least 12 weeks duration, according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and as confirmed by version 7.0 of the Mini International Neuropsychiatric Interview (MINI).
- Participant is on prescribed SSRI (citalopram / escitalopram / sertraline / paroxetine / fluoxetine) or SNRI (venlafaxine / desvenlafaxine / duloxetine) antidepressant treatment, at approved and stable dose, for at least 4 weeks prior to screening that is insufficient/ineffective.
- The participant is deemed to have inadequate response (less than 50% symptom reduction) to their current antidepressant based on the investigator judgment and the treatment history.
You likely can't join if
- History or presence of a medical condition or disease that in the Investigator’s opinion would place the participant at an unacceptable risk as a result of trial participation.
- Hypersensitivity to the active substance or to any of the excipients of Samyr or placebo (lactose).
- Participants with known genetic defects which affect the methionine cycle and/or cause homocystinuria and/or hyperhomocysteinaemia (e.g. cystathionine beta-synthase deficiency, defects of vitamin B12 metabolism).
- Treatment with Monoamine Oxidase (MAO)-inhibitors including selegiline and moclobemide, during the 4 weeks prior to screening.
- Treatment with linezolid or pimozide during the 4 weeks prior to screening; these must not be taken during study.
- Treatment with prohibited medication prior to screening as detailed in Appendix 1.
See the full eligibility criteria
Who can join
- Written and signed informed consent needs to be provided by participants before starting any protocol-specific procedures.
- Male and female participants between the ages of 18 to 65 years, both ages inclusive.
- Participant who is able and willing to comply with the requirements of the study protocol including the visits scheme, assessments and scales.
- Primary diagnosis of MDD of at least 12 weeks duration, according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and as confirmed by version 7.0 of the Mini International Neuropsychiatric Interview (MINI).
- Participant is on prescribed SSRI (citalopram / escitalopram / sertraline / paroxetine / fluoxetine) or SNRI (venlafaxine / desvenlafaxine / duloxetine) antidepressant treatment, at approved and stable dose, for at least 4 weeks prior to screening that is insufficient/ineffective.
- The participant is deemed to have inadequate response (less than 50% symptom reduction) to their current antidepressant based on the investigator judgment and the treatment history.
- Participants who have a HDRS-17 score between 15-20 at screening. The baseline score must remain ≤20 and should not have >10% reduction between screening and baseline (randomization visit).
What rules you out
- History or presence of a medical condition or disease that in the Investigator’s opinion would place the participant at an unacceptable risk as a result of trial participation.
- Hypersensitivity to the active substance or to any of the excipients of Samyr or placebo (lactose).
- Participants with known genetic defects which affect the methionine cycle and/or cause homocystinuria and/or hyperhomocysteinaemia (e.g. cystathionine beta-synthase deficiency, defects of vitamin B12 metabolism).
- Treatment with Monoamine Oxidase (MAO)-inhibitors including selegiline and moclobemide, during the 4 weeks prior to screening.
- Treatment with linezolid or pimozide during the 4 weeks prior to screening; these must not be taken during study.
- Treatment with prohibited medication prior to screening as detailed in Appendix 1.
- Cardiac disorder which in the Investigator’s opinion would place the participant at an unacceptable risk from trial participation.
- Known QT interval prolongation or congenital long QT syndrome.
- Currently treatment with products that are known to prolong the QT interval.
- Hepatic values that in the Investigator’s opinion would place the participant at an unacceptable risk as a result of trial participation.
- Female participants who are pregnant or breast-feeding or are planning to become pregnant during the study.
- Any clinically significant abnormality in electrocardiogram (ECG) or safety laboratory tests that in the Investigator’s opinion would place the participant at an unacceptable risk as a result of trial participation.
- Female participants of childbearing potential who are not able/willing to use oral contraception or acceptable methods of contraception as outlined in this protocol (Protocol Section 4.3), from the time of screening and for the duration of the study, through study completion.
- Receipt of another investigational drug within 45 days prior to screening, or if the screening visit is within 5 half-lives of another investigational drug received (whichever is longer) or scheduled to receive another investigational drug during the current study period.
- Any elective surgery requiring hospitalization planned during the study period.
- Any lifetime history of bipolar disorders or psychotic disorders (other than MDD with psychotic features in a prior but not the current episode) as per the MINI.
- History of drug abuse and/or marijuana use and/or alcohol dependence during the 3 years prior to screening.
- The participant is, in the investigator’s opinion, at significant current risk of harming himself/herself, or provides the following answers on the C-SSRS at screening: - “Yes” to Question 4 or 5 on the Lifetime version Suicidal Ideation section and the ideation was within the last 3 months at Screening Visit, OR - “Yes” to question on the Lifetime version Suicidal Behavior section (other than preparatory behavior) and the ideation was within the last 3 months at Screening Visit.
- Use of more than any 4 acceptable antidepressant treatments since the diagnosis of depression.
- Previous treatment with Samyr which was not effective or resulted in an AE, or already treated with Samyr for the current episode.
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, 18-64 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.