Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06174116 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Aug 2026 to Dec 2026
    • Study completion date: Nov 2026 to Mar 2027
    v6
  2. Re-verified, no change to tracked fieldsv5
  3. Start date changed from estimate of Mar 2024 to Apr 2, 2024v4
  4. Lead sponsor: Xiaoduo Fan to University of Massachusetts, Worcesterv3 Show 4 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Start date: Feb 2024 to Mar 2024
    • Site details revised
    • Study title expanded, about 9 words
  5. Start date: Dec 2023 to Feb 2024
    • Trial status: Recruiting to Not Yet Recruiting
    • Site details revised
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT06174116
Lead Sponsor University of Massachusetts, Worcester
Collaborators: Intra-Cellular Therapies, Inc.
Conditions
(from sponsor)		 Schizophrenia, Schizo Affective Disorder
Related terms Psychotic Disorders, Schizophrenia
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov