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WithdrawnPhase 4

Relationship Between Efficacy of Lumateperone and Brain Glutamate and Dopamine

Key facts

Who runs it
University of New Mexico
Where
Albuquerque, United StatesSee the site
Trial code
Status
Withdrawn
Phase
Phase 4
Started
11 May 2023
Ended
28 Feb 2024
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Lumateperone
  • Risperidone
Record updated
5 March 2025
Why it stopped
PI was unable to meet 1 year recruitment goal

Who can take part

Age
18 years to 40 years
Sex
Women and men
Healthy volunteers
Can take part

The registry criteria, word for word

Show all 5 criteriaShow less

Other criteria

  • Patient group:
  • Inclusion:; Diagnosis of DSM-5 schizophrenia, bipolar-I mania and mixed episodes with psychotic features, schizophreniform, schizoaffective, delusional, and unspecified schizophrenia spectrum and other psychotic disorders, established with SCID-P for DSM-5; age between 18 and 40 years old; antipsychotic exposure no greater than 50 mg of olanzapine equivalents (Gardner et al. AJP, 2010) in the 7 days previous to baseline assessments
  • Exclusion:; neurological disorder, intellectual disability, history of severe head trauma (unconciousness >10 min); diagnosis of active substance use disorder (except for nicotine and cannabinoids [cannabinoids use is a risk factor for psychosis]); Healthy Volunteers (HV) group:
  • Inclusion:; age between 18 and 40 years old
  • Exclusion:; current or past psychiatric disorder (assessed with the SCID-NP; subjects with past history of anxiety or depressive disorders receiving no active treatment in the previous 12 months may be included); past or current diagnosis of neurological disorder, history of severe head trauma or diagnosis of active substance use disorder (except for nicotine or cannabinoids); and c) history of a psychotic disorder in first-degree relatives

Where in United States

  • University of New MexicoAlbuquerque, United States

About the trial

What the trial wants to find out

This study will examine the differential relationships between antipsychotic efficacy and changes in dopaminergic and glutamatergic brain metabolism in lumateperone and risperidone treated early psychosis patients. Baseline glutamate and dopamine brain scans, and symptom severity measures will be collected, followed by repeated measures at 6 weeks. Half of the early psychosis patients will be treated with lumateperone, half with risperidone. Healthy control subejcts will also be examined once.

The 2 groups in the trial

  • LumateperoneTreatment being tested

    Lumateperone 42 mg capsule 1 PO QD for 6 weeks

  • RisperidoneExisting treatment, for comparison

    Risperidone starts 1 mg capsule PO QD for 1 week; then titrated blindly per clinical response and tolerability up to: 2 mg capsule QD starting in week 2; up to 3 mg capsule QD starting in week 3; and up to 4 mg capsule QD starting in week 4. Total risperidone exposure of 6 weeks.

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
The Relationship Between the Efficacy of Lumateperone and Central Glutamate and Dopaminergic Metabolism: A Comparison With Risperidone in First Episode Psychosis
Record updated
5 March 2025