Metabolic Effects of Adjunctive Lumateperone Treatment in Clozapine-Treated Patients With Schizophrenia
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Massachusetts, Worcester
About this trial
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).
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Lumateperone
- Placebo
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Massachusetts, Worcester
Lead sponsor
Intra-Cellular Therapies, Inc.
Collaborator
Source ClinicalTrials.gov