Aripiprazole Lauroxil for Preventing Psychotic Relapse After an Initial Schizophrenia Episode

PATS 20184225

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.

2019-12-16

2022-10-01

2022-10-01

Terminated

Early phase I

15

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Controlled Trial; 12-month longitudinal follow-through study (anticipate enrolling at least 128 patients of whom 90 will be randomized to one of the two arms)', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'open label'}}, 'enrollmentInfo': {'count': 15, 'type': 'ACTUAL'}}

2023-11-28