CORAL - Clinical and Biomarker Assessment of Efficacy of Cognitive Remediation in Patients with Schizophrenia or Schizoaffective Disorder Stabilized on Lurasidone
The purpose of this study is to evaluate the effects on cognitive and functional outcomes of patients with schizophrenia or schizoaffective disorder stabilized on Lurasidone as evidenced by comparing 30 sessions of cognitive remediation to active control group. Lurasidone is a new FDA-approved antipsychotic medication. Subjects must be 18-55 years of age to participate. Study visits will take place at the North Carolina Psychiatric Research Center, located at the former Dorothea Dix Hospital Campus in Raleigh, NC and the Clinical and Translational Research Center at UNC, Chapel Hill, NC.
The study visits will occur as follows:
- For subjects entering the study on lurasidone, the first 4 weeks they will be evaluated for clinical stabilization on lurasidone.
- For subjects taking an antipsychotic other than lurasidone, subjects will transition from current medication to lurasidone the first 8 weeks.
- After stabilization on lurasidone, there are two optional studies using functional magnetic resonance imaging (fMRI) and electroencephalography (EEG), performed at UNC Hospitals.
- At week 8, the subject will be randomly assigned to one of two groups for the next phase of the study. Groups will meet twice per week for 75 minutes for the next 4 – 6 months:
- The cognitive remediation group consists of computer based cognitive training that allows the subject to enhance cognitive skills through repeated exercises which gradually increase in difficulty. A 15 minute group will be held after each training session to connect how the newly learned cognitive skills can benefit an individual in everyday situations and recovery goals.
- The cognitive control group consists of mental activity groups, including computer based puzzles and exercises, followed by a 15 minute group discussing healthy behaviors.
Subjects who complete all the study visits over the 8 month period, including 30 computer sessions, will receive $900. For completion of the optional fMRI study, compensation will be $225. For completion of the optional EEG’s, compensation will be $60. For more information, please contact Joy Watson at 919-733-5227.