Clinical trial NCT06174116: Metabolic Effects of Adjunctive Lumateperone Treatment in Clozapine-Treated Patients With Schizophrenia
Official title: Metabolic Effects of Adjunctive Lumateperone Treatment in Clozapine-Treated Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Schizophrenia
Schizo Affective Disorder
Keywords: Clozapine
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: Intra-Cellular Therapies, Inc.
First posted: 2023-12-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized, double-blind, placebo-controlled trial.
Primary purpose: TREATMENT

Brief summary: 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).

Detailed 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.

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)

Primary outcomes:
measure: Body Mass Index (BMI)
timeFrame: Week 0, Week 6, and Week 12
measure: Waist Circumference
timeFrame: Week 0, Week 6, and Week 12
measure: Body Composition - Fat Mass
timeFrame: Week 0 and Week 12
measure: Body Composition - Total Body Mass
timeFrame: Week 0 and Week 12
measure: Body Composition - Fat Percentage
timeFrame: Week 0 and Week 12
measure: HBA1C
timeFrame: Week 0 and Week 12
measure: Fasting Insulin
timeFrame: Week 0, Week 6, and Week 12
measure: LDL Particle
timeFrame: Week 0 and Week 12
measure: Small LDL Particle
timeFrame: Week 0 and Week 12
measure: Large HDL Particle
timeFrame: Week 0 and Week 12
measure: Large VLDL Particle
timeFrame: Week 0 and Week 12
Secondary outcomes:
measure: Positive and Negative Symptoms Scale (PANSS)
timeFrame: Week 0, Week 6, and Week 12
measure: Calgary Depression Scale (CDRS)
timeFrame: Week 0, Week 6, and Week 12
measure: Clinical Global Impression - Severity Scale (CGI-S)
timeFrame: Week 0, Week 6, and Week 12
measure: Clinical Global Impression - Improvement Scale (CGI-I)
timeFrame: Week 0, Week 6, and Week 12
measure: Insomnia Severity Index (ISI)
timeFrame: Week 0, Week 6, and Week 12
measure: Henrichs Carpenter Quality of Life Scale (QLS)
timeFrame: Week 0, Week 6, and Week 12
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMass Chan Medical School
state: Massachusetts
Study officials:
affiliation: UMass Chan Medical School
name: Xiaoduo Fan, MD
role: PRINCIPAL_INVESTIGATOR
References: