C-Cog in Early Course Schizophrenia Study

• Status: Not yet recruiting
• Trial end date: 2025-07-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Miami
• Collaborator: Alkermes, Inc.
• Treatments: Aripiprazole; Aripiprazole lauroxil

Criteria

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.