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Atypical Antipsychotic

Medication + Cognitive Training for Schizophrenia

Phase 4

Recruiting

Led By Dante Durand, MD

Research Sponsored by University of Miami

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial looks at how stable mental health affects recovery from schizophrenia in those newly diagnosed.

Who is the study for?

This trial is for adults with schizophrenia who have been hospitalized or relapsed as outpatients fewer than four times. They must be willing to take long-acting injectable medication and participate in rehabilitation but cannot have had prior treatment resistance, previous long-acting injections, or be unable to consent.

What is being tested?

The study tests whether Aripiprazole Lauroxil (a long-acting injectable antipsychotic) combined with computerized cognitive training can help patients with early-stage schizophrenia recover functionally when they are clinically stable.

What are the potential side effects?

Aripiprazole Lauroxil may cause weight gain, restlessness, insomnia, headache, anxiety, nausea or vomiting. The computerized training has no physical side effects but could potentially lead to frustration or fatigue.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The percentage of participants who develop sustained remission of symptoms of schizophrenia as measured as having a score of 3 or less on all 6 critical items from the Positive and Negative Syndrome Scale (PANSS)

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Aripiprazole and Computerized Cognitive and Functional Skills Training GroupExperimental Treatment2 Interventions

Participants in this arm will receive long-acting injectable aripiprazole every 2 months formulation for 12 consecutive months. Participants in this arm will also receive Computerized cognitive and functional skills training during the first 12 weeks of study participation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Aripiprazole Lauroxil

2014

Completed Phase 4

~440

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