Schizophrenia study: ML-007C-MA
Official title A Long-Term Open-Label Study of ML-007C-MA in Adults With Schizophrenia
ClinicalTrials.gov ID: NCT07459647
What this study is testing
What is ML-007C-MA?
This is an investigational medicine being studied as a potential treatment for schizophrenia.
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 study aims to see if the medicine is safe, well-tolerated, and effective over a long period.
- Who it's for
- The study is looking for adults with schizophrenia who have recently finished a related study or are joining directly.
- What's involved
- Participants will take the medicine ML-007C-MA and undergo regular check-ups to monitor their health and response to the treatment.
- Time commitment
- The study lasts for 52 weeks and requires regular visits to the clinic.
- Phase 2: a mid-size study of how well it works
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
- Must be able and willing to provide informed consent for all required study procedures.
- Has a primary diagnosis of schizophrenia based on the DSM-5 criteria that is confirmed by semi-structured clinical interview (Mini International...
- May benefit from long-term pharmacotherapy for schizophrenia, based on assessment of the investigator.
- Is appropriate for an outpatient level of care and resides in a stable living situation, based on assessment of the investigator.
- Has an identified reliable informant(s) available to participate in relevant assessments.
You likely can't join if
- Has any DSM-5 disorder, other than schizophrenia, within the 12 months before Screening that is primarily responsible for the current symptoms or...
- Is discontinuing effective and well-tolerated antipsychotic therapy for the purpose of enrolling in this study.
- Has received any prohibited therapy within the Screening Period unless discontinued before Baseline.
- Has current evidence of a clinically significant and/or unstable medical comorbidity at Screening or Baseline.
- Has clinically significant abnormal physical examination, ECG, or clinical safety laboratory result at Screening or Baseline.
- Has an elevated risk of suicidal behavior.
See the full eligibility criteria
- Must be able and willing to provide informed consent for all required study procedures.
- Has a primary diagnosis of schizophrenia based on the DSM-5 criteria that is confirmed by semi-structured clinical interview (Mini International Neuropsychiatric Interview for DSM-5).
- May benefit from long-term pharmacotherapy for schizophrenia, based on assessment of the investigator.
- Is appropriate for an outpatient level of care and resides in a stable living situation, based on assessment of the investigator.
- Has an identified reliable informant(s) available to participate in relevant assessments. Site staff may serve as the informant if the site has had regular contact with the participant for \>1 year. Key
- Has any DSM-5 disorder, other than schizophrenia, within the 12 months before Screening that is primarily responsible for the current symptoms or functional impairment.
- Is discontinuing effective and well-tolerated antipsychotic therapy for the purpose of enrolling in this study.
- Has received any prohibited therapy within the Screening Period unless discontinued before Baseline.
- Has current evidence of a clinically significant and/or unstable medical comorbidity at Screening or Baseline.
- Has clinically significant abnormal physical examination, ECG, or clinical safety laboratory result at Screening or Baseline.
- Has an elevated risk of suicidal behavior.
- Has a known allergy to ML-007C-MA, its active ingredients or their excipients.
- Has a DSM-5 diagnosis of moderate to severe substance use disorder (except tobacco or caffeine use disorder) within the 12 months before Screening (confirmed using MINI version 7.0.2 at Screening).
- Has an elevated risk of violent or destructive behavior, based on participant history and investigator judgment.
The study team makes the final eligibility decision.
Where it is enrolling
- Little Rock, Arkansas, United States
- Rogers, Arkansas, United States
- Bellflower, California, United States
- Cerritos, California, United States
- Culver City, California, United States
- Garden Grove, California, United States
- Lemon Grove, California, United States
- Long Beach, California, United States
- Los Angeles, California, United States
- Montclair, California, United States
- Oceanside, California, United States
- Orange, California, United States
- Pico Rivera, California, United States
- Riverside, California, United States
- San Diego, California, United States
- Sherman Oaks, California, United States
- Torrance, California, United States
- Hollywood, Florida, United States
- Miami, Florida, United States
- Miami Lakes, Florida, United States
+ 22 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 Little Rock, Arkansas, United States; Rogers, Arkansas, United States; Bellflower, California, United States; Cerritos, California, United States; Culver City, California, United States; Garden Grove, California, United States and 36 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.