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