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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06174116
• Other study ID #: STUDY00001339
• Status: Recruiting
• Phase: Phase 4
• Start date: April 2, 2024
• Est. completion date: November 2026

Study information

• Verified date: May 2024
• Source: University of Massachusetts, Worcester
• Contact: Abaigeal Grant, BA
• Phone: 5088563027
• Email: abaigeal.grant2[@]umassmed.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Mood Disorders
• Psychotic Disorders
• Schizo Affective Disorder
• Schizophrenia

Intervention

Drug:
• Lumateperone
Subject will take lumateperone (Caplyta) for 12 weeks, in addition to their regular medications.
• Placebo
Subject will take placebo for 12 weeks, in addition to their regular medications.

Locations

Country	Name	City	State
United States	UMass Chan Medical School	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	Intra-Cellular Therapies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Mass Index (BMI)	Participant Body Mass Index will be measured by standard methods	Week 0, Week 6, and Week 12
Primary	Waist Circumference	Participant Waist Circumference will be measured by standard methods	Week 0, Week 6, and Week 12
Primary	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.	Week 0 and Week 12
Primary	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.	Week 0 and Week 12
Primary	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).	Week 0 and Week 12
Primary	HBA1C	Participant HBA1C will be measured using standard labs	Week 0 and Week 12
Primary	Fasting Insulin	Participant Fasting Insulin will be measured using standard labs	Week 0, Week 6, and Week 12
Primary	LDL Particle	LDL particle size will be determined using the NMR spectroscopy (LipoScience, Raleigh, NC)	Week 0 and Week 12
Primary	Small LDL Particle	Small LDL particle size will be determined using the NMR spectroscopy (LipoScience, Raleigh, NC)	Week 0 and Week 12
Primary	Large HDL Particle	Large HDL Particle size will be determined using the NMR spectroscopy (LipoScience, Raleigh, NC)	Week 0 and Week 12
Primary	Large VLDL Particle	Large VLDL Particle size will be determined using the NMR spectroscopy (LipoScience, Raleigh, NC)	Week 0 and Week 12
Secondary	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.	Week 0, Week 6, and Week 12
Secondary	Calgary Depression Scale (CDRS)	The CDRS is used to assess depression symptoms in patients with schizophrenia.	Week 0, Week 6, and Week 12
Secondary	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.	Week 0, Week 6, and Week 12
Secondary	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.	Week 0, Week 6, and Week 12
Secondary	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.	Week 0, Week 6, and Week 12
Secondary	Henrichs Carpenter Quality of Life Scale (QLS)	The QLS is a 21-item scale providing information on symptoms and functioning in patients with schizophrenia.	Week 0, Week 6, and Week 12