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A study to evaluate if aticaprant added to a current antidepressant and given up to one year is safe and would help improve depression.
EU CTIS ID: 2023-508163-74-00
What this study is testing
To assess the long-term safety and tolerability of aticaprant administered as adjunctive therapy to a current antidepressant (SSRI or SNRI) in all participants with MDD
- 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
- Transferred patients: - Participants must have completed the Double Blind Treatment Phase of Study 67953964MDD3001 or Study 67953964MDD3002 study.
- Participant must be medically stable on the basis of physical examination, medical history, vital signs (including blood pressure), and 12-lead ECG performed at baseline and prior to Open Label treatment initiation.
- Direct entry patients: - Male or female, aged 18 to 74 years of age, inclusive.
- Be medically stable on the basis of physical examination, medical history, vital signs, and 12-lead ECG performed at screening and baseline
- Be medically stable on the basis of clinical laboratory tests performed at screening
- Meet DSM-5 diagnostic criteria for recurrent or single episode MDD, without psychotic features. Participants 65 years of age or older must have had the first onset of depression prior to 55 years of age.
You likely can't join if
- Transferred-entry participants: - Participant has been non-compliant with the study intervention administration in the Double Blind (DB) Treatment Phase in either of Studies 67953964MDD3001 or 67953964MDD3002
- Has a current homicidal ideation/intent, per the investigator's clinical judgment, or has suicidal ideation with some intent to act within 3 months prior to the start of the screening phase
- The evaluation of the benefit versus risk of continued aticaprant treatment is not favorable for the participant in the opinion of the investigator.
- Participant is reporting suicidal ideation with intent to act or suicidal behavior at baseline.
- Participant has taken any prohibited therapies that would not permit dosing on Day 1, as noted in the pre-study and concomitant therapy section.
- Participant has any condition or situation/circumstance for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
See the full eligibility criteria
Who can join
- Transferred patients: - Participants must have completed the Double Blind Treatment Phase of Study 67953964MDD3001 or Study 67953964MDD3002 study.
- Participant must be medically stable on the basis of physical examination, medical history, vital signs (including blood pressure), and 12-lead ECG performed at baseline and prior to Open Label treatment initiation.
- Direct entry patients: - Male or female, aged 18 to 74 years of age, inclusive.
- Be medically stable on the basis of physical examination, medical history, vital signs, and 12-lead ECG performed at screening and baseline
- Be medically stable on the basis of clinical laboratory tests performed at screening
- Meet DSM-5 diagnostic criteria for recurrent or single episode MDD, without psychotic features. Participants 65 years of age or older must have had the first onset of depression prior to 55 years of age.
- Have had an inadequate response to at least 1 oral antidepressant treatment, administered at an adequate dose and duration in the current episode of depression.
- Is receiving and tolerating well a SSRI/SNRI for depressive symptoms at screening, at a stable dose for at least 6 weeks
- Have a HDRS-17 total score of 20 or higher at the first and second screening interviews and must not demonstrate a clinically significant improvement between the first and the second independent HDRS-17 assessments
What rules you out
- Transferred-entry participants: - Participant has been non-compliant with the study intervention administration in the Double Blind (DB) Treatment Phase in either of Studies 67953964MDD3001 or 67953964MDD3002
- Has a current homicidal ideation/intent, per the investigator's clinical judgment, or has suicidal ideation with some intent to act within 3 months prior to the start of the screening phase
- The evaluation of the benefit versus risk of continued aticaprant treatment is not favorable for the participant in the opinion of the investigator.
- Participant is reporting suicidal ideation with intent to act or suicidal behavior at baseline.
- Participant has taken any prohibited therapies that would not permit dosing on Day 1, as noted in the pre-study and concomitant therapy section.
- Participant has any condition or situation/circumstance for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
- Direct-entry participants: - Have had in the current depressive episode, no response (treatment failure) to 5 or more antidepressant treatments including the current SSRI/SNRI
- Has a history or evidence of clinically meaningful noncompliance with current antidepressant therapy.
- Has a history of moderate-to-severe substance use disorder including alcohol use disorder according to DSM-5 criteria within 6 months before screening.
- Has had in the current episode an inadequate response to adequate course of intravenous or intranasal ketamine or esketamine, electroconvulsive therapy (i.e, at least 7 treatments), vagal nerve stimulation, or a deep brain stimulation device
The study team makes the final eligibility decision.
Where it's taking place
- South Africa
- Korea, Republic of
- China
- Mexico
- Australia
- United Kingdom
- United States
- Argentina
- Canada
- Taiwan
- Brazil
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include South Africa; Korea, Republic of; China; Mexico; Australia; United Kingdom and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
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.