Frontlight ResearchEarly access
TerminatedPhase 4
C-Cog in Early Course Schizophrenia Study
Key facts
- Who runs it
- University of Miami
- Where
- Miami, United StatesSee the site
- Trial code
- Status
- Terminated
- Phase
- Phase 4
- People taking part
- 1 person enrolled
- Started
- 23 Jan 2024
- Ended
- 3 Mar 2025
- Type of study
- Interventional
- Treatments tested
- Aripiprazole Lauroxil
- Computerized cognitive and functional skills training
- Record updated
- 6 February 2026
- Why it stopped
- Recruitment issues
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 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
Who cannot take part
- Prior Long Acting Injectable treatment
- Positive illicit drug screen other than cannabis (rescreening allowed in 4 weeks for drug positive cases)
- 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
- Hypersensitivity to Aripiprazole
- History of treatment resistance as evidenced by clozapine treatment
- Primary diagnosis other than schizophrenia
- Current Suicide Risk
- Pregnancy
- Unable to give personal informed consent
Where in United States
- Jackson Memorial HospitalMiami, United States
About the trial
What the trial wants to find out
The purpose of this study is to examine the role of clinical stability in functional recovery. in first episode schizophrenia.
The group in the trial
- Aripiprazole and Computerized Cognitive and Functional Skills Training GroupTreatment being tested
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.
Treatment: Aripiprazole Lauroxil and Computerized cognitive and functional skills training
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Comprehensive Treatment of Early Course Schizophrenia: A Nonrandomized Study of Long Acting Injectable Antipsychotic Medication Combined With Cognitive and Functional Skills Training
- Record updated
- 6 February 2026