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

Part of paid clinical trials in Shreveport, Louisiana.

Sponsor
Louisiana State University Health Sciences Center Shreveport
Study ID
NCT06482554
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Lumateperone 42 mg — DRUG
    Standard treatment with lumateperone
  • Risperidone 2 mg — DRUG
    Standard treatment with other antipsychotic drugs

Study Details

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.

Key Dates

Start date
Jun 30, 2024
Status verified
Jun 2024
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Lumateperone
    42mg capsule, once a day for 8 weeks
  • Active Comparator: Existing medication
    Existing medication reformulated in capsule, once or twice daily (as currently prescribed) for 8 weeks

Primary Outcome Measure

Change in AES-C Score [ Time Frame: 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
LSU Health ShreveportShreveportLouisiana71101
Stephanie Saunders, MA, CCRC
[email protected]
318-675-7065
Shawn McNeil, MD
[email protected]
318-675-7065
Shawn McNeil, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Shreveport, LA

By condition
Schizophrenia
By specialty
PsychiatryMental healthBehavioral health
By research site
LSU Health Shreveport· Shreveport, LA

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