protocolSection identificationModule nctId: NCT06328140, orgStudyIdInfo id: Skyland 001, briefTitle: Sleep Quality, Cognitive Performance, and Computerized Cognitive Training, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2026-04-14, completionDateStruct date: 2026-04-14, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: George West Mental Health Foundation d/b/a Skyland Trail, class: OTHER, collaborators name: Sumitomo Pharmaceuticals America, descriptionModule briefSummary: Poor sleep quality is common in neuropsychiatric conditions and some of the problems associated with poor sleep at night may be due to medication side effects or reduced efficacy of certain treatments. Poor sleep quality has been implicated in cognitive impairments, with the sleep quality to cognition association so strong that specialized assessments have been developed to examine the subjective association between poor nighttime sleep and daytime cognitive impairment.Computerized cognitive training (CCT) is a training procedure designed to build cognitive skills, with a goal of improvement of functional outcomes. CCT is also a learning-based approach and previous studies have shown that successful CCT interventions lead to changes in brain circuitry. It is also known, however, that many cases who are treated with CCT fail to make treatment-related gains. Recent studies have suggested that this may be associated with failures to engage in the training procedures, which could be related to sleep related impairments.Increased anticholinergic load can also substantially disrupt the process of training related gains directly. Antihistaminergic effects, common to many antidepressant and antipsychotic medications, can lead to daytime sedation and sleepiness, which both interferes with treatment but also interferes with nighttime sleep as wellIn previous clinical trials, Lurasidone was associated with reductions in sleepiness and with cognitive gains that exceeded practice effects. One viable hypothesis is that Lurasidone has both direct beneficial effects on cognition and substantial indirect benefits, due to the lack of histamine receptor occupancy, lack of anticholinergic effects, and direct promotion of positive nighttime sleep outcomes.Thus, a broad-spectrum naturalistic comparison of Lurasidone-treated patients with patients treated with other medications is proposed. This would include examining the level of engagement in CCT treatment, measurement of CCT training gains, and relating engagement and training gains with concurrent sleep quality, measured by actigraphy., conditionsModule conditions: Bipolar Disorder, conditions: Major Depressive Disorder, conditions: Psychosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Lurasidone, interventions name: FDA Approved antidepressant treatment, outcomesModule primaryOutcomes measure: Improvement in Cognitive Performance, secondaryOutcomes measure: Training Engagement in Cognitive training, secondaryOutcomes measure: Nighttime sleep measured with actigraphy, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: George West Mental Health Foundation, DBA Skyland Trail, city: Atlanta, state: Georgia, zip: 30329, country: United States, contacts name: Ben W Hunter, MD, role: CONTACT, phone: 866-504-4966, email: bhunter@skylandtrail.org, contacts name: Ben W Hunter, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Alex O Rothbaum, PhD, MPH, role: SUB_INVESTIGATOR, contacts name: Philip D Harvey, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 33.749, lon: -84.38798, hasResults: False