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Recruiting NCT06174116

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

Phase IV Interventional Schizophrenia Schizo Affective Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lumateperone, Placebo.
Who it may be relevant to
Registry conditions: Schizophrenia, Schizo Affective Disorder. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

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

Primary outcome measures

  • Body Mass Index (BMI) [Time frame: Week 0, Week 6, and Week 12]
  • Waist Circumference [Time frame: Week 0, Week 6, and Week 12]
  • Body Composition - Fat Mass [Time frame: Week 0 and Week 12]
  • Body Composition - Total Body Mass [Time frame: Week 0 and Week 12]
  • Body Composition - Fat Percentage [Time frame: Week 0 and Week 12]
  • HBA1C [Time frame: Week 0 and Week 12]
  • Fasting Insulin [Time frame: Week 0, Week 6, and Week 12]
  • LDL Particle [Time frame: Week 0 and Week 12]
  • Small LDL Particle [Time frame: Week 0 and Week 12]
  • Large HDL Particle [Time frame: Week 0 and Week 12]
Secondary outcome measures (6)
  • Positive and Negative Symptoms Scale (PANSS) [Time frame: Week 0, Week 6, and Week 12]
  • Calgary Depression Scale (CDRS) [Time frame: Week 0, Week 6, and Week 12]
  • Clinical Global Impression - Severity Scale (CGI-S) [Time frame: Week 0, Week 6, and Week 12]
  • Clinical Global Impression - Improvement Scale (CGI-I) [Time frame: Week 0, Week 6, and Week 12]
  • Insomnia Severity Index (ISI) [Time frame: Week 0, Week 6, and Week 12]
  • Henrichs Carpenter Quality of Life Scale (QLS) [Time frame: Week 0, Week 6, and Week 12]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • UMass Chan Medical School — Worcester

Identifiers

NCT: NCT06174116 · STUDY00001339

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗