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NCT Number: NCT06174116

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

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).

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Key information

Conditions

Schizophrenia Mental Disorders Psychotic Disorders Schizo Affective Disorder Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UMass Chan Medical School

Worcester, Massachusetts, 01655, United States

Location status: Recruiting

Location contact

Abaigeal Grant

CONTACT

[email protected]

508-856-3027

Xiaoduo Fan, MD, MPH

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Lumateperone

Drug

Subject will take lumateperone (Caplyta) for 12 weeks, in addition to their regular medications.

Other names: Caplyta

Placebo

Drug

Subject will take placebo for 12 weeks, in addition to their regular medications.

Primary outcomes

  1. Body Mass Index (BMI)

    Time frame: Week 0, Week 6, and Week 12

    Participant Body Mass Index will be measured by standard methods

  2. Waist Circumference

    Time frame: Week 0, Week 6, and Week 12

    Participant Waist Circumference will be measured by standard methods

  3. Body Composition - Fat Mass

    Time frame: Week 0 and Week 12

    Body Composition will be assessed using the research-grade medical body composition analyzer Seca 515/514. Fat mass will be measured in grams.

  4. Body Composition - Total Body Mass

    Time frame: Week 0 and Week 12

    Body Composition will be assessed using the research-grade medical body composition analyzer Seca 515/514. Total Body Mass will be measured in grams.

  5. Body Composition - Fat Percentage

    Time frame: Week 0 and Week 12

    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).

  6. HBA1C

    Time frame: Week 0 and Week 12

    Participant HBA1C will be measured using standard labs

  7. Fasting Insulin

    Time frame: Week 0, Week 6, and Week 12

    Participant Fasting Insulin will be measured using standard labs

  8. LDL Particle

    Time frame: Week 0 and Week 12

    LDL particle size will be determined using the NMR spectroscopy (LipoScience, Raleigh, NC)

  9. Small LDL Particle

    Time frame: Week 0 and Week 12

    Small LDL particle size will be determined using the NMR spectroscopy (LipoScience, Raleigh, NC)

  10. Large HDL Particle

    Time frame: Week 0 and Week 12

    Large HDL Particle size will be determined using the NMR spectroscopy (LipoScience, Raleigh, NC)

  11. Large VLDL Particle

    Time frame: Week 0 and Week 12

    Large VLDL Particle size will be determined using the NMR spectroscopy (LipoScience, Raleigh, NC)

Secondary outcomes

  1. Positive and Negative Symptoms Scale (PANSS)

    Time frame: Week 0, Week 6, and Week 12

    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.

  2. Calgary Depression Scale (CDRS)

    Time frame: Week 0, Week 6, and Week 12

    The CDRS is used to assess depression symptoms in patients with schizophrenia.

  3. Clinical Global Impression - Severity Scale (CGI-S)

    Time frame: Week 0, Week 6, and Week 12

    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.

  4. Clinical Global Impression - Improvement Scale (CGI-I)

    Time frame: Week 0, Week 6, and Week 12

    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.

  5. Insomnia Severity Index (ISI)

    Time frame: Week 0, Week 6, and Week 12

    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.

  6. Henrichs Carpenter Quality of Life Scale (QLS)

    Time frame: Week 0, Week 6, and Week 12

    The QLS is a 21-item scale providing information on symptoms and functioning in patients with schizophrenia.

Study contacts

Contact information is provided by the study sponsor or research team.

Abaigeal Grant, BA

CONTACT

[email protected]

5088563027

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

  • Intra-Cellular Therapies, Inc.

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Dec 18, 2023
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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