Aripiprazole Lauroxil for Preventing Psychotic Relapse After an Initial Schizophrenia Episode

Phase 4TerminatedNCT04203056

University of California, Los Angeles15 enrolled

Overview

This 12-month study will evaluate the efficacy of aripiprazole lauroxil compared to oral aripiprazole in preventing the re-emergence of psychotic symptoms in patients with a recent onset of schizophrenia.

This is a single-site 12-month open-label randomized study comparing the efficacy of the FDA-approved long-acting formulation of aripiprazole lauroxil to the efficacy of oral aripiprazole among patients with a recent onset of schizophrenia, schizophreniform, or schizoaffective (depressed) disorder. All assessments and treatment will take place at the UCLA Aftercare Research Program (300 UCLA Medical Plaza, Los Angeles, CA 90095), which is a program that specializes in the treatment and study of individuals with a recent onset of schizophrenia. The primary goal is to evaluate the efficacy of aripiprazole lauroxil compared to oral aripiprazole in preventing the re-emergence of psychotic symptoms in patients with a recent onset of schizophrenia. All patients on oral medications will, at least initially, be treated with oral aripiprazole.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Schizophrenia Schizoaffective Disorder, Depressive Type Schizophreniform Disorder

Interventions

Aripiprazole LauroxilDRUG

12 month longitudinal aripiprazole lauroxil treatment and assessment follow-through

ARI-ORALDRUG

oral aripiprazole

AL-NCDDRUG

Aripiprazole Lauroxil 675 MG/2.4 ML Intramuscular Suspension, Extended Release

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Is between 18 and 45 years of age, inclusive, at Screening. 2. Has a diagnosis of schizophreniform disorder, schizophrenia, or schizoaffective disorder, depressed type. 3. Has a first episode of a psychotic illness that occurred within the 24 months before entry. 4. Fluency (oral and written) in the English language. 5. Exhibits tolerability to ARI ORAL during the Stabilization period. 6. Resides within commuting distance of the UCLA Aftercare Research Program in a stable living situation where the patient can be located. 7. Agrees to abide by the contraceptive requirements of the protocol. 8. Additional criteria may apply Exclusion Criteria: 1. Evidence of a known neurological disorder (e.g., epilepsy) or significant head injury. 2. Premorbid IQ less than 70. 3. Is currently pregnant or breastfeeding, or is planning to become pregnant during the study. 4. Is currently on a long-acting injectable antipsychotic medication and it is clinically contra-indicated to switch to oral aripiprazole. 5. History of poor or inadequate response to an adequate trial of oral or injectable aripiprazole. 6. Has received AL-LAI or IM depot aripiprazole within two months prior to Randomization. 7. Has alcohol or substance abuse as a prominent clinical problem or makes the primary diagnosis not possible to confirm. 8. Is currently being treated with clozapine. 9. Has participated in a clinical drug trial involving any drug within the past two months. 10. Has a current DSM-5 diagnosis of bipolar disorder, or schizoaffective disorder, bipolar type, based on the screening SCID. 11. Patient is an imminent danger to himself/herself. 12. History of neuroleptic malignant syndrome, malignant hyperthermia, or clinically significant tardive dyskinesia. 13. Additional criteria may apply.

Locations (1)

University of California, Los Angeles

Los Angeles, California, United States

Outcomes

Primary Outcomes

Exacerbation or Relapse of Psychotic Symptoms

Number of participants who experienced an exacerbation and/or relapse following a period of absence or relative low levels of psychotic symptoms based on the expanded 24-item version of the Brief Psychiatric Rating Scale

Time frame: 12 months

Secondary Outcomes

Change in Role Ratings on the Global Functioning Scale From Baseline to 12 Months

The groups will be compared on change in this measure of role functioning. Scores range from 1 to 10, with higher indicating better role functioning. Change scores can theoretically range from 0 to 9

Time frame: mean change from baseline to the 12 month point

Change From Baseline to One-Year in the "MATRICS Consensus Cognitive Battery (MCCB)" Overall Composite T-Score.

The change from Baseline to One-year on the MATRICS Consensus Cognitive Battery Overall Composite score. MATRICS is the abbreviation for Measurement and Treatment Research to Improve Cognition in Schizophrenia. T scores do not have an absolute minimum or maximum. Higher scores represent better cognition. The sex and age adjusted T-score was used. The T-Score has a population mean of 50 and standard deviation of 10. Fewer subjects analyzed than enrolled because only 9 subjects reached the 12 month point by study discontinuation and had MCCB data.

Time frame: 12 months

Data from ClinicalTrials.gov

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