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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Lumateperone
DrugSubject will take lumateperone (Caplyta) for 12 weeks, in addition to their regular medications.
Placebo
DrugSubject will take placebo for 12 weeks, in addition to their regular medications.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: LumateperoneExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Body Mass Index (BMI)
Participant Body Mass Index will be measured by standard methods
Time frame
Week 0, Week 6, and Week 122
Waist Circumference
Participant Waist Circumference will be measured by standard methods
Time frame
Week 0, Week 6, and Week 123
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 124
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 12Secondary outcomes
1
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 122
Calgary Depression Scale (CDRS)
The CDRS is used to assess depression symptoms in patients with schizophrenia.
Time frame
Week 0, Week 6, and Week 123
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 124
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 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Massachusetts, Worcester
Lead sponsor
Intra-Cellular Therapies, Inc.
Collaborator
Source ClinicalTrials.gov