C-Cog in Early Course Schizophrenia Study

• Sponsor: University of Miami (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05662306
• Collaborator: Alkermes, Inc. (Industry)
• Enrollment: 60
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 26
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: Aripiprazole Lauroxil; Behavioral: Computerized cognitive and functional skills training	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comprehensive Treatment of Early Course Schizophrenia: A Nonrandomized Study of Long Acting Injectable Antipsychotic Medication Combined With Cognitive and Functional Skills Training
• Anticipated Study Start Date: Jun 1, 2023
• Anticipated Primary Completion Date: May 31, 2025
• Anticipated Study Completion Date: Jul 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Aripiprazole and Computerized Cognitive and Functional Skills Training Group 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; 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.

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jackson Memorial Hospital	Miami	Florida	United States	33136

Sponsors and Collaborators

• University of Miami
• Alkermes, Inc.

Investigators

• Principal Investigator: Dante Durand, MD, University of Miami Miller School

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dante Durand, Associate Professor of Psychiatry, University of Miami
• ClinicalTrials.gov Identifier: NCT05662306
• Other Study ID Numbers: 20211098
• First Posted: Dec 22, 2022
• Last Update Posted: Dec 22, 2022
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Dante Durand, Associate Professor of Psychiatry, University of Miami: Relapse; Remission; Recovery
• Additional relevant MeSH terms: Schizophrenia; Aripiprazole; Aripiprazole lauroxil

Study Results

No Results Posted as of Dec 22, 2022