C-Cog in Early Course Schizophrenia Study

Study Overview
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Brief Summary
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The purpose of this study is to examine the role of clinical stability in functional recovery. in first episode schizophrenia.

Official Title
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Comprehensive Treatment of Early Course Schizophrenia: A Nonrandomized Study of Long Acting Injectable Antipsychotic Medication Combined With Cognitive and Functional Skills Training

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Aripiprazole Lauroxil
* Behavioral: Computerized cognitive and functional skills training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults Diagnosis of schizophrenia Current Hospitalization or outpatient relapse Fewer than four previous admissions Willing to accept long-acting injectable treatment and participate in rehabilitation Exclusion Criteria: Primary diagnosis other than schizophrenia Prior Long Acting Injectable treatment Current Suicide Risk Hypersensitivity to Aripiprazole Pregnancy Positive illicit drug screen other than cannabis (rescreening allowed in 4 weeks for drug positive cases) Unable to give personal informed consent History of treatment resistance as evidenced by clozapine treatment Unable to stop treatment with medications that are strong Cytochrome (CYP) 2D6 or CYP 3A4 inhibitors and or strong CYP3A4 inducers (2.3, 7.1) for at 14 days prior to initiation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aripiprazole and Computerized Cognitive and Functional Skills Training Group<br>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. | Drug: Aripiprazole Lauroxil<br>* 1064 mg 2-month long-acting injectable administered as an intramuscular injection over a 12-month period.<br>Behavioral: Computerized cognitive and functional skills training<br>* Self-administered cognitive and technology focused skills training, administered at home for 2 hours per week for the first 12 weeks of the 12-month study period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | PANSS has 6 critical items with each item being scored from 1 to 7 with the higher score indicating more severe symptoms. A score of 3 or less on all six critical items defines the presence of remission. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Relapse, Remission, Recovery