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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
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
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)
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
Find a Location
Who is running the clinical trial?
University of MiamiLead Sponsor
935 Previous Clinical Trials
422,157 Total Patients Enrolled
3 Trials studying Schizophrenia
509 Patients Enrolled for Schizophrenia
Alkermes, Inc.Industry Sponsor
115 Previous Clinical Trials
26,920 Total Patients Enrolled
22 Trials studying Schizophrenia
6,038 Patients Enrolled for Schizophrenia
Dante Durand, MDPrincipal InvestigatorUniversity of Miami Miller School
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with schizophrenia.I have previously received long-acting injectable treatments.I am willing to get long-acting injections and join a rehab program.My primary diagnosis is not schizophrenia.I cannot stop taking certain strong medications for 14 days before starting the trial.I am currently in the hospital or having a relapse without being admitted.I am unable to understand and give consent for my own treatment.I have been treated with clozapine for treatment-resistant conditions.I have not tested positive for illicit drugs (except cannabis) or can wait 4 weeks for a retest.
Research Study Groups:
This trial has the following groups:- Group 1: Aripiprazole and Computerized Cognitive and Functional Skills Training Group
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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