Aripiprazole Lauroxil for Preventing Psychotic Relapse After an Initial Schizophrenia Episode
Condition: Schizophrenia; Schizoaffective Disorder, Depressive Type; Schizophreniform Disorder
MeSH terms: Schizophrenia; Psychotic Disorders; Depressive Disorder; Depression
Intervention: Aripiprazole Lauroxil; ARI-ORAL; AL-NCD
Intervention description: 12 month longitudinal aripiprazole lauroxil treatment and assessment follow-through; oral aripiprazole; Aripiprazole Lauroxil 675 MG/2.4 ML Intramuscular Suspension, Extended Release
Intervention MeSH terms: Aripiprazole; Aripiprazole lauroxil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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)
Masking: None (Open Label)
Masking description: open label
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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.