Aripiprazole Lauroxil for Preventing Psychotic Relapse After an Initial Schizophrenia Episode

Schizophrenia Clinical Trial

— APPRAISE  

Official title:

Aripiprazole Lauroxil for Preventing Psychotic Relapse After an Initial Schizophrenia Episode

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04203056
• Other study ID #: PATS 20184225
• Status: Terminated
• Phase: Phase 4
• Start date: December 16, 2019
• Est. completion date: October 1, 2022

Study information

• Verified date: November 2023
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Psychotic Disorders
• Schizoaffective Disorder, Depressive Type
• Schizophrenia
• Schizophreniform Disorder

Intervention

Drug:
• Aripiprazole Lauroxil
12 month longitudinal aripiprazole lauroxil treatment and assessment follow-through
• ARI-ORAL
oral aripiprazole
• AL-NCD
Aripiprazole Lauroxil 675 MG/2.4 ML Intramuscular Suspension, Extended Release

Locations

Country	Name	City	State
United States	University of California, Los Angeles	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	Alkermes, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months
Secondary	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	mean change from baseline to the 12 month point
Secondary	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.	12 months