C-Cog in Early Course Schizophrenia Study

University of Miami

Status and phase: Terminated; Phase 4

Conditions: Schizophrenia

Treatments: Behavioral: Computerized cognitive and functional skills training; Drug: Aripiprazole Lauroxil

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05662306

20211098

Details and patient eligibility

About

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

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Aripiprazole and Computerized Cognitive and Functional Skills Training Group

Experimental group

Description:

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:

Drug: Aripiprazole Lauroxil

Behavioral: Computerized cognitive and functional skills training