C-Cog in Early Course Schizophrenia Study

Phase 4

Terminated

• Conditions: Schizophrenia
• Interventions: Drug: Aripiprazole Lauroxil; Behavioral: Computerized cognitive and functional skills training

• Registration Number: NCT05662306
• Lead Sponsor: University of Miami

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-14
• Study First Submitted QC: 2022-12-14
• Study First Posted: 2022-12-22
• Study Start: 2024-01-23
• Status Verified: 2025-03
• Primary Completion: 2025-03-03
• Study Completion: 2025-03-03
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aripiprazole and Computerized Cognitive and Functional Skills Training Group	Computerized cognitive and functional skills training	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.
Aripiprazole and Computerized Cognitive and Functional Skills Training Group	Aripiprazole Lauroxil	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.

Primary Outcome Measures

Name	Time	Method
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)	6 months	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.

Trial Locations

Locations (1)

Jackson Memorial Hospital; 🇺🇸 Miami, Florida, United States