C-Cog in Early Course Schizophrenia Study

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05662306
• Other study ID #: 20211098
• Status: Recruiting
• Phase: Phase 4
• Start date: January 23, 2024
• Est. completion date: July 31, 2025

Study information

• Verified date: March 2024
• Source: University of Miami
• Contact: Dante Durand, MD
• Phone: 305-355-8237
• Email: ddurand[@]med.miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adults

2. Diagnosis of schizophrenia

3. Current Hospitalization or outpatient relapse

4. Fewer than four previous admissions

5. Willing to accept long-acting injectable treatment and participate in rehabilitation

Exclusion Criteria:

1. Primary diagnosis other than schizophrenia

2. Prior Long Acting Injectable treatment

3. Current Suicide Risk

4. Hypersensitivity to Aripiprazole

5. Pregnancy

6. Positive illicit drug screen other than cannabis (rescreening allowed in 4 weeks for drug positive cases)

7. Unable to give personal informed consent

8. History of treatment resistance as evidenced by clozapine treatment

9. 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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Aripiprazole Lauroxil
1064 mg 2-month long-acting injectable administered as an intramuscular injection over a 12-month period.

Behavioral:
• Computerized cognitive and functional skills training
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.

Locations

Country	Name	City	State
United States	Jackson Memorial Hospital	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Alkermes, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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