Health TrialsbyHealthPanel

Lumateperone for the Improvement of Apathy in Patients With Psychotic Symptoms.

ConditionsApathySchizophreniaSchizophrenia; Psychosis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorLouisiana State University Health Sciences Center Shreveport

About this trial

This study is looking to determine if Lumateperone improves motivation in patients with schizophrenia or schizoaffective disorders who show high levels of apathy as judged by AES-C-Apathy (Apathy Evaluation Scale - Clinician - Apathy) assessment and to examine a possible correlation between improvement in apathy scores and changes in elements of the PANSS (Positive and Negative Syndrome Scale) due to treatment with Lumateperone.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female subjects between the ages of 18-65 that have been diagnosed with Schizophrenia, Schizoaffective Disorder or Schizophrenia Spectrum and Other Psychotic Disorders.

A BPRS score > 35 at the screening visit.

An AES-C score > 32 at the screening visit.

If the subject is on a therapeutic regimen, that regimen must be stable for at least 30 days prior to screening. A therapeutic regimen may include medication, supplements, and/or probiotics.

Disqualifiers

A BPRS score < 35 at the screening visit.

An AES-C score < 32 at the screening visit.

Have any clinically significant medical condition or an unstable intercurrent illness that would, in the opinion of the Investigator, preclude study participation.

Are currently taking more than one antipsychotic medication.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lumateperone 42 mg

    Drug

    Standard treatment with lumateperone

  • Risperidone 2 mg

    Drug

    Standard treatment with other antipsychotic drugs

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: LumateperoneActive comparator 1 intervention
Group B: Existing medicationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in AES-C Score

Difference between the mean change in the AES-C score from baseline (V1) to Week 8 (V3) for 42 mg/day lumateperone vs. current antipsychotic medication.

Time frame
8 weeks

Secondary outcomes

1

Change in PANSS Score

Difference between the mean change in the PANSS score from baseline (V1) to Week 8 (V3) for 42 mg/day lumateperone vs. current antipsychotic medication.

Time frame
8 weeks
2

Change in BPRS Score

Difference between the mean change in the BPRS (Brief Psychiatric Rating Scale) score from baseline (V1) to Week 8 (V3) for 42 mg/day lumateperone vs. current antipsychotic medication.

Time frame
8 weeks
3

Correlations between AES-C and PANSS Scores

Correlation between the AES-C score at Week 8 (V3) and negative symptoms score from PANSS at Week 8 (V3) for 42 mg/day lumateperone in comparison to current antipsychotic medication.

Time frame
8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Louisiana State University Health Sciences Center Shreveport

Lead sponsor

Source ClinicalTrials.gov
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