Major Depressive Disorder study: Icalcaprant
Official title A Study to Assess Change in Disease Activity and Adverse Events of Oral Icalcaprant in Adult Participants With Major Depressive Disorder
ClinicalTrials.gov ID: NCT07276997
What this study is testing
What is Icalcaprant?
an investigational oral capsule being studied as a potential treatment for major depressive disorder
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether a new pill called Icalcaprant helps with major depression. It also checks how safe the pill is and what side effects it causes.
- Who it's for
- You may be able to join if you are an adult with major depression right now.
- What's involved
- You would take a pill once a day for six weeks. You would go to a clinic for check-ups, blood tests, and questionnaires.
- Time commitment
- The study lasts six weeks, plus a 30-day safety check-in later.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Participants with a diagnosis of major depressive disorder (MDD) according to the Diagnostic and Statistical Manual of Mental Disorders, fifth...
- Body Mass Index (BMI) is ≥ 18.0 to ≤ 35.0 kg/m\^2
- Currently experiencing an major depressive episode (MDE) beginning at least 4 weeks prior to consent and not exceeding 6 months prior to Screening
- Normal physical examination findings, clinical laboratory test results, vital signs, and 12-lead ECG results at Visit 1 or abnormal results that are...
You likely can't join if
- Has failed (no more than 25% response on Antidepressant Treatment History Questionnaire (ATRQ)) 3 or more antidepressant treatments during the...
- History of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same...
The study team makes the final eligibility decision.
Where it is enrolling
- Dothan, Alabama, United States
- Phoenix, Arizona, United States
- Little Rock, Arkansas, United States
- Anaheim, California, United States
- Imperial, California, United States
- Lemon Grove, California, United States
- Long Beach, California, United States
- Sherman Oaks, California, United States
- Temecula, California, United States
- Walnut Creek, California, United States
- Hollywood, Florida, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Riverview, Florida, United States
- Atlanta, Georgia, United States
- Norcross, Georgia, United States
- Chicago, Illinois, United States
- Warrenville, Illinois, United States
- Las Vegas, Nevada, United States
+ 10 more site(s).
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, but 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 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Dothan, Alabama, United States; Phoenix, Arizona, United States; Little Rock, Arkansas, United States; Anaheim, California, United States; Imperial, California, United States; Lemon Grove, California, United States and 24 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.