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Tests treatment safety and results for Schizophrenia
Official title A Study of the Feasibility, Safety and Tolerability of Aticaprant as Adjunctive Treatment in Participants With Schizophrenia
ClinicalTrials.gov ID: NCT07615426
What this study is testing
What is Aticaprant?
Aticaprant is an investigational medicine, being studied as a potential treatment for schizophrenia.
Also referred to as JNJ-67953964.
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
- The purpose of this study is to see how feasible it is to enroll participants with schizophrenia and for them to complete the study/assessments. It will also assess how safe and tolerable aticaprant is when compared with placebo in participants with schizophrenia.
- Phase 1: an early, usually small safety study
- 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 55
You may be able to join if
- Clinically stable with a diagnosis of schizophrenia confirmed by the mini international neuropsychiatric interview [MINI] for psychotic disorders
- The participant must be on a stable dose of only one atypical antipyschotic medication
- Must be receiving outpatient treatment for schizophrenia from a psychiatric provider at the time of screening
- At the Baseline visit, must have a presence of permitted background antipsychotic medication based on blood samples drawn at the screening visit
- If taking an antidepressant or anxiolytic, no dose changes are allowed to have occurred within 8 weeks prior to screening or throughout the double...
You likely can't join if
- Has one or more of the current or prior (lifetime) diagnostic and statistical manual of mental disorders (5th edition) (DSM-5) diagnoses (based on...
- Has a history of moderate-to-severe substance use disorder, including alcohol use disorder, according to DSM-5 criteria within 6 months before...
- Current cannabis (marijuana, pot, grass, hash, etcetera) use exceeds 3 to 5 times over the past 30 days as measured by items from the national survey...
- Has a history in the past 6 months of a peptic ulcer, or lifetime history of upper gastrointestinal bleeding, or known untreated helicobacter pylori...
- Has current homicidal ideation/intent, per the investigator's clinical judgment
The study team makes the final eligibility decision.
Where it's taking place
- Garden Grove, California, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Kalamazoo, Michigan, United States
- Cedarhurst, New York, United States
- Staten Island, New York, United States
- Austin, Texas, United States
- Richardson, Texas, United States
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 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Garden Grove, California, United States; Atlanta, Georgia, United States; Chicago, Illinois, United States; Kalamazoo, Michigan, United States; Cedarhurst, New York, United States; Staten Island, New York, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.