C-Cog in Early Course Schizophrenia Study

NCT05662306 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 20211098
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Schizophrenia

Keywords

Relapse; Remission; Recovery

Outcome Measures

Primary Outcomes (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)

  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

Study Arms (1)

Aripiprazole and Computerized Cognitive and Functional Skills Training Group

EXPERIMENTAL

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; Behavioral: Computerized cognitive and functional skills training

Interventions

Aripiprazole Lauroxil DRUG

1064 mg 2-month long-acting injectable administered as an intramuscular injection over a 12-month period.

Aripiprazole and Computerized Cognitive and Functional Skills Training Group

Computerized cognitive and functional skills training BEHAVIORAL

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.

Aripiprazole and Computerized Cognitive and Functional Skills Training Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults
• Diagnosis of schizophrenia
• Current Hospitalization or outpatient relapse
• Fewer than four previous admissions
• Willing to accept long-acting injectable treatment and participate in rehabilitation

You may not qualify if:

• Primary diagnosis other than schizophrenia
• Prior Long Acting Injectable treatment
• Current Suicide Risk
• Hypersensitivity to Aripiprazole
• Pregnancy
• Positive illicit drug screen other than cannabis (rescreening allowed in 4 weeks for drug positive cases)
• Unable to give personal informed consent
• History of treatment resistance as evidenced by clozapine treatment
• 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.

Sponsors & Collaborators

• University of Miami: lead
• Alkermes, Inc.: collaborator

Study Sites (1)

Jackson Memorial Hospital

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Schizophrenia; Recurrence

Interventions

aripiprazole lauroxil

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dante Durand, Associate Professor of Psychiatry
• Organization: University of Miami

ddurand@med.miami.edu

305-355-8237

Study Officials

• Dante Durand, MD

  University of Miami Miller School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: December 22, 2022
• Study Start: January 23, 2024
• Primary Completion: March 3, 2025
• Study Completion: March 3, 2025
• Last Updated: February 6, 2026
• Results First Posted: February 6, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)