C-Cog in Early Course Schizophrenia Study

January 21, 2026 updated by: Dante Durand, University of Miami

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • Jackson Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: 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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

Alkermes, Inc.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2024

Primary Completion (Actual)

March 3, 2025

Study Completion (Actual)

March 3, 2025

Study Registration Dates

First Submitted

December 14, 2022

First Submitted That Met QC Criteria

December 14, 2022

First Posted (Actual)

December 22, 2022

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

January 21, 2026

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20211098

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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