The comparative effectiveness of clozapine versus long-acting injectable antipsychotics among adult patients with treatment non-responsive schizophrenia

Active Project Grant Awarded Last action

Award ID
F31MH143563
Recipient
Awarding agency
Obligated
$42,651

Award facts

Assistance listing
93.242 Mental Health Research Grants
Completion date 0% complete
Place of performance
Newark, NJ 07107, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

Abstract
Schizophrenia is a debilitating mental health disorder affecting approximately 3 million americans, characterized by significant morbidity and premature mortality. Despite treatment with first-line oral antipsychotic medications, a substantial proportion of schizophrenia patients continue to experience treatment non-responsive symptoms. We refer to this population as having non-responsive schizophrenia. Two causes of non-responsive schizophrenia are treatment-resistant schizophrenia (TRS) and antipsychotic nonadherence. TRS is defined as treatment non-responsive symptoms despite trialing at least 2 first-line oral antipsychotics with adequate adherence, affecting approximately 20-30% of patients with schizophrenia. For these patients, clozapine is the only FDA-approved pharmacologic treatment. The other cause of non-responsive schizophrenia, antipsychotic nonadherence, is estimated to occur in approximately 30-60% of schizophrenia patients. For these patients, clinical guidelines recommend initiating a long-acting injectable antipsychotic (LAIA), which helps ensure consistent medication delivery compared to oral formulations. Therefore, based on current clinical guidelines, prior oral antipsychotic adherence guides whether those that have non-responsive schizophrenia should be initiated on clozapine or a LAIA. However, determining whether non-responsive schizophrenia is due to TRS, or due to non-adherence is complicated because (1) prior adherence is not a binary measure (non- adherent VS. Adherent), but a spectrum that is influenced by a patient's experienced benefits from treatment and (2) clinicians are unable to consistently assess prior adherence using objective measures (e.g., blood levels), relying on often inaccurate patient self-reporting. This creates considerable uncertainty in identifying the optimal treatment based on adherence history. A greater understanding of the effectiveness of clozapine and laias, and the potential effect-modifying role of prior adherence to oral antipsychotic medications, would advance care for patients with non-responsive schizophrenia. This study aims to address this clinical GAP by conducting a comparative effectiveness study of clozapine versus laias in patients with non-responsive schizophrenia across the prior oral antipsychotic adherence spectrum. This study will leverage 13 years (2007-2019) of linked national medicare and medicaid data to achieve the following specific aims: (1) to characterize the epidemiology of clozapine and LAIA use in publicly insured individuals with schizophrenia, and (2) to estimate the comparative effectiveness of initiating clozapine or a LAIA in preventing psychiatric hospitalization and antipsychotic treatment discontinuation in individuals with non-responsive schizophrenia, assessing how prior oral antipsychotic adherence modifies treatment response. This study will employ an active-comparator new-user design within a target trial emulation (TTE) framework. By advancing the understanding of the comparative effectiveness of clozapine and laias, this project aligns with the overall mission of the national institute of mental health to transform the understanding and treatment of mental illnesses through clinical research.

Quick answers

Who received award F31MH143563?

F31MH143563 was awarded to Rutgers The State University Of New Jersey by National Institute of Mental Health (National Institutes of Health) on February 1, 2027.

How much is award F31MH143563 worth?

$42,651 has been obligated on F31MH143563.

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