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

University of Massachusetts, Worcester

Status and phase: Enrolling; Phase 4

Conditions: Schizophrenia; Schizo Affective Disorder

Treatments: Drug: Placebo; Drug: Lumateperone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06174116

STUDY00001339

Details and patient eligibility

About

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).

Full description

This is a 12-week study in which we investigate how adjunctive lumateperone affects lipid particle size and body composition in clozapine-treated patients with schizophrenia; in addition, we will investigate if lumateperone improves insomnia. Outcome measures will record a variety of assessments related to participants' psychiatric symptoms, psychosocial functioning, and biological outcomes.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

2 Placebo capsules taken orally per day for 12 weeks

Treatment:

Drug: Placebo

Lumateperone

Experimental group

Description:

42mg (two 21mg capsules) lumateperone (Caplyta) taken orally per day for 12 weeks

Treatment:

Drug: Lumateperone