RightFit
RecruitingPhase 4

Metabolic Effects of Adjunctive Lumateperone Treatment in Clozapine-Treated Patients With Schizophrenia

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will be randomly assigned to either take lumateperone (Caplyta) or a placebo for 12 weeks, in addition to their regularly prescribed clozapine."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether adding lumateperone (Caplyta) to clozapine can reduce weight gain, high blood sugar, and high bad cholesterol. It is for people with schizophrenia or schizoaffective disorder who take clozapine. Participants are assigned by chance to take lumateperone or a placebo (a pill with no active drug) for 12 weeks while continuing clozapine.

The main question this study is trying to answer is whether lumateperone, an FDA-approved antipsychotic drug, can help reduce possible side effects of clozapine, such as weight gain and elevated levels of sugar and bad cholesterol. Participants will be randomly assigned to either take lumateperone (Caplyta) or a placebo for 12 weeks, in addition to their regularly prescribed clozapine. During their participation, patients will answer questions about their psychiatric and daily functioning, have blood drawn, and have their body composition analyzed (similar to stepping on a scale).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have schizophrenia or schizoaffective disorder, confirmed through a mental health interview.
  • Have taken clozapine for at least 6 months.
  • Have had no change in the dose of antipsychotic medicines for at least 1 month.
  • Have a clear history of taking medicines as prescribed outside the hospital.
  • Use appropriate birth control during the study if able to become pregnant.

Who can't join

  • Have mental health symptoms that the lead study doctor judges are not stable.
  • Do not have a steady dose of antipsychotic medicines.
  • Currently have a substance use disorder, except one involving caffeine or nicotine.
  • Have a serious medical condition that is not stable, such as severe heart, liver, or kidney disease.
  • Have a history of a seizure disorder.
  • Are pregnant or breastfeeding.
  • Have taken lumateperone in the past 3 months.
  • Have taken aripiprazole, brexpiprazole, or cariprazine in the past 3 months.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Meets the DSM-5 criteria for diagnoses of schizophrenia or schizoaffective disorder based on the MINI International Neuropsychiatric Interview (MINI 7.0) * On clozapine treatment for at least 6 months * Stable dose of antipsychotic treatment for at least 1 month * Well established compliance with outpatient medications * Subjects of child-bearing potential are required to practice appropriate birth control methods during the study. Exclusion Criteria: * Psychiatrically unstable per clinical judgement by the principal investigator * Patients not on stable dose of antipsychotic medications * Currently meets DSM-5 criteria for any substance use disorder other than caffeine and nicotine * Significant, unstable medical conditions including severe cardiovascular, hepatic, renal or other medical diseases * History of a seizure disorder * Pregnancy or breastfeeding * On lumateperone treatment in the past 3 months * On a dopamine partial agonist antipsychotic agent in the past 3 months (aripiprazole, brexpiprazole, cariprazine)

Study sites (1)

MA