Back to resultsC-Cog in Early Course Schizophrenia Study
Primary Purpose
Schizophrenia
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Aripiprazole Lauroxil
Computerized cognitive and functional skills training
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Relapse, Remission, Recovery
Eligibility Criteria
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.
Sites / Locations
- Jackson Memorial HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Aripiprazole and Computerized Cognitive and Functional Skills Training Group
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05662306
First Posted
December 14, 2022
Last Updated
October 11, 2023
Sponsor
University of Miami
Collaborators
Alkermes, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05662306
Brief Title
C-Cog in Early Course Schizophrenia Study
Official Title
Comprehensive Treatment of Early Course Schizophrenia: A Nonrandomized Study of Long Acting Injectable Antipsychotic Medication Combined With Cognitive and Functional Skills Training
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
May 31, 2025 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
Alkermes, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to examine the role of clinical stability in functional recovery. in first episode schizophrenia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Relapse, Remission, Recovery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Aripiprazole and Computerized Cognitive and Functional Skills Training Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Aripiprazole Lauroxil
Intervention Description
1064 mg 2-month long-acting injectable administered as an intramuscular injection over a 12-month period.
Intervention Type
Behavioral
Intervention Name(s)
Computerized cognitive and functional skills training
Intervention Description
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.
Primary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dante Durand, MD
Phone
305-355-8237
Email
ddurand@med.miami.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Gabriela Vargas, MBA
Phone
305 243 2708
Email
gvargas3@med.miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dante Durand, MD
Organizational Affiliation
University of Miami Miller School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jackson Memorial Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dante Durand, MD
Phone
305-355-8237
Email
ddurand@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Dante Durand, MD
First Name & Middle Initial & Last Name & Degree
Philip Harvey, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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C-Cog in Early Course Schizophrenia Study
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