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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
Subject will take lumateperone (Caplyta) for 12 weeks, in addition to their regular medications.
Subject will take placebo for 12 weeks, in addition to their regular medications.
UMass Chan Medical School
Worcester, Massachusetts, United States
RECRUITINGBody Mass Index (BMI)
Participant Body Mass Index will be measured by standard methods
Time frame: Week 0, Week 6, and Week 12
Waist Circumference
Participant Waist Circumference will be measured by standard methods
Time frame: Week 0, Week 6, and Week 12
Body Composition - Fat Mass
Body Composition will be assessed using the research-grade medical body composition analyzer Seca 515/514. Fat mass will be measured in grams.
Time frame: Week 0 and Week 12
Body Composition - Total Body Mass
Body Composition will be assessed using the research-grade medical body composition analyzer Seca 515/514. Total Body Mass will be measured in grams.
Time frame: Week 0 and Week 12
Body Composition - Fat Percentage
Body Composition will be assessed using the research-grade medical body composition analyzer Seca 515/514. Fat Percentage will be calculated as fat mass (in grams) divided by total mass (in grams).
Time frame: Week 0 and Week 12
HBA1C
Participant HBA1C will be measured using standard labs
Time frame: Week 0 and Week 12
Fasting Insulin
Participant Fasting Insulin will be measured using standard labs
Time frame: Week 0, Week 6, and Week 12
LDL Particle
LDL particle size will be determined using the NMR spectroscopy (LipoScience, Raleigh, NC)
Time frame: Week 0 and Week 12
Small LDL Particle
Small LDL particle size will be determined using the NMR spectroscopy (LipoScience, Raleigh, NC)
Time frame: Week 0 and Week 12
Large HDL Particle
Large HDL Particle size will be determined using the NMR spectroscopy (LipoScience, Raleigh, NC)
Time frame: Week 0 and Week 12
Large VLDL Particle
Large VLDL Particle size will be determined using the NMR spectroscopy (LipoScience, Raleigh, NC)
Time frame: Week 0 and Week 12
Positive and Negative Symptoms Scale (PANSS)
PANSS is a measure used to assess symptom severity in patients with schizophrenia. It consists of three sections: Positive scale has 7 items, Negative scale has 7 items, and General Psychopathology has 16 items. Each item (symptom) will be scored on a 7-point scale with higher scores representing increasing levels of psychopathology: 1) Absent, 2) Minimal, 3) Mild, 4) Moderate, 5) Moderate severe, 6) Severe, and 7) Extreme.
Time frame: Week 0, Week 6, and Week 12
Calgary Depression Scale (CDRS)
The CDRS is used to assess depression symptoms in patients with schizophrenia.
Time frame: Week 0, Week 6, and Week 12
Clinical Global Impression - Severity Scale (CGI-S)
The CGI-S is an observer rated scale. The CGI-S measures illness severity on a 7-point Likert scale 1) Normal, not at all ill, 2) Borderline mentally ill, 3) Mildly ill, 4) Moderately ill, 5) Markedly ill, 6) Severely ill, and 7) Among the most extremely ill patient.
Time frame: Week 0, Week 6, and Week 12
Clinical Global Impression - Improvement Scale (CGI-I)
The CGI-I is an observer rated scale. The CGI-I is used to measure improvement in illness and uses a 7-point Likert scale: 1) Very much improved, 2) Much improved, 3) Minimally improved, 4) No change 5) Minimally worse, 6) Much worse, 7) Very much worse.
Time frame: Week 0, Week 6, and Week 12
Insomnia Severity Index (ISI)
The ISI is a 7-question survey assessing symptoms of insomnia. The maximum score is 28 with higher scores indicating greater severity. The ISI is a reliable and valid instrument to assess insomnia and treatment response.
Time frame: Week 0, Week 6, and Week 12
Henrichs Carpenter Quality of Life Scale (QLS)
The QLS is a 21-item scale providing information on symptoms and functioning in patients with schizophrenia.
Time frame: Week 0, Week 6, and Week 12
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