Trial Outcomes & Findings for C-Cog in Early Course Schizophrenia Study (NCT NCT05662306)

Last Updated: 2026-02-06

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

1 participants

Primary outcome timeframe

6 months

Results posted on

2026-02-06

Participant Flow

Participant milestones

Participant milestones
Measure	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. Aripiprazole Lauroxil: 1064 mg 2-month long-acting injectable administered as an intramuscular injection over a 12-month period. 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.
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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. Aripiprazole Lauroxil: 1064 mg 2-month long-acting injectable administered as an intramuscular injection over a 12-month period. 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.
Overall Study Sponsor terminated and PI withdrew participant	1

Baseline Characteristics

C-Cog in Early Course Schizophrenia Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aripiprazole and Computerized Cognitive and Functional Skills Training Group n=1 Participants 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. Aripiprazole Lauroxil: 1064 mg 2-month long-acting injectable administered as an intramuscular injection over a 12-month period. 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.
Age, Categorical <=18 years	0 Participants n=41 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=41 Participants
Age, Categorical >=65 years	0 Participants n=41 Participants
Sex: Female, Male Female	0 Participants n=41 Participants
Sex: Female, Male Male	1 Participants n=41 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=41 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=41 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=41 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=41 Participants
Race (NIH/OMB) Asian	0 Participants n=41 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=41 Participants
Race (NIH/OMB) Black or African American	0 Participants n=41 Participants
Race (NIH/OMB) White	1 Participants n=41 Participants
Race (NIH/OMB) More than one race	0 Participants n=41 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=41 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Aripiprazole and Computerized Cognitive and Functional Skills Training Group n=1 Participants 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. Aripiprazole Lauroxil: 1064 mg 2-month long-acting injectable administered as an intramuscular injection over a 12-month period. 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.
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)	100 Percentage of participants

Adverse Events

Aripiprazole and Computerized Cognitive and Functional Skills Training Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dante Durand, Associate Professor of Psychiatry

University of Miami

Phone: 305-355-8237

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place