Clinical trial NCT04203056: Aripiprazole Lauroxil for Preventing Psychotic Relapse After an Initial Schizophrenia Episode
Official title: Aripiprazole Lauroxil for Preventing Psychotic Relapse After an Initial Schizophrenia Episode
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Schizophrenia
Schizoaffective Disorder, Depressive Type
Schizophreniform Disorder
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Alkermes, Inc.
First posted: 2019-12-18
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

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.

Primary outcomes:
measure: Exacerbation or Relapse of Psychotic Symptoms
timeFrame: 12 months
Secondary outcomes:
measure: Change in Role Ratings on the Global Functioning Scale From Baseline to 12 Months
timeFrame: mean change from baseline to the 12 month point
measure: Change From Baseline to One-Year in the "MATRICS Consensus Cognitive Battery (MCCB)" Overall Composite T-Score.
timeFrame: 12 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Kenneth L Subotnik, PhD
role: PRINCIPAL_INVESTIGATOR
References: