Sleep Quality, Cognitive Performance, and Computerized Cognitive Training

NCT06328140 | Withdrawn DMC FDA Drug

• 1 other identifier: Skyland 001
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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 well In 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.

Conditions

Bipolar Disorder; Major Depressive Disorder; Psychosis

Outcome Measures

Primary Outcomes (1)

• Improvement in Cognitive Performance

  Composite Score on the Brief Assessment of Cognition: Standard score with population mean of 0 and Standard deviation of 1.0. Range is from -4.0 to 4.0; higher scores reflect better performance

  Baseline to 8 weeks of treatment

Secondary Outcomes (2)

• Training Engagement in Cognitive training

  Baseline to 8 weeks of treatment

• Nighttime sleep measured with actigraphy

  Baseline to 8 weeks of treatment

Study Arms (2)

Lurasidone Treatment

Patients with bipolar disorder or psychotic disorders for whom lurasidone is a US Food and Drug Administration (FDA)-approved treatment. Patients will be treated with a daily dose of 40-80 mg./day for schizophrenia and 30-60 mg./day for bipolar disorder.

Drug: Lurasidone

Treatment as usual for major depression

Patients with major depression will received treatment with antidepressant treatments that are approved by the US FDA for treatment of major depression. All dosing will be required to be consistent with the FDA approved package insert.

Drug: FDA Approved antidepressant treatment

Interventions

Lurasidone DRUG

Daily medication treatment

Lurasidone Treatment

FDA Approved antidepressant treatment DRUG

Daily treatment with an FDA approved antidepressant

Also known as: Any FDA Approved antidepressant

Treatment as usual for major depression

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Sampled from consecutive admissions to residential treatment at Skyland Trail.

You may qualify if:

• Meets Diagnostic Criteria
• Patients with major depression or bipolar disorder will have baseline Brief Assessment of \*Cognition (BACS) composite scores of 0.5 Standard deviations (SD) below normative (0.0) standards
• Patients with schizophrenia spectrum conditions will have baseline BACS composite scores 1.0 SD below normative (0.0) standards
• Able and willing to give informed consent
• Expected length of stay at least 8 weeks.

You may not qualify if:

• Symptoms Attributed to neurological Causes, including stroke or seizure disorder
• Sensory impairments precluding CCT
• Current treatment with vortioxetine or tricyclic antidepressants
• Patients with mood disorders will be excluded if they have BACS composite scores more than 2.5 SD below normative (0.0)standards Patients with schizophrenia spectrum conditions will be excluded if they have BACS composite scores more than 3.0 SD below normative (0.0) standards

Sponsors & Collaborators

• George West Mental Health Foundation d/b/a Skyland Trail: lead
• Sumitomo Pharmaceuticals America: collaborator

Study Sites (1)

George West Mental Health Foundation, DBA Skyland Trail

Atlanta, Georgia, 30329, United States

Location

Related Publications (2)

• Harvey PD, Siu CO, Loebel AD. Change in daytime sleepiness and cognitive function in a 6-month, double-blind study of lurasidone and quetiapine XR in patients with schizophrenia. Schizophr Res Cogn. 2016 Jun 2;5:7-12. doi: 10.1016/j.scog.2016.05.002. eCollection 2016 Sep.

  PMID: 28740811 BACKGROUND

• Harvey PD, Balzer AM, Kotwicki RJ. Training engagement, baseline cognitive functioning, and cognitive gains with computerized cognitive training: A cross-diagnostic study. Schizophr Res Cogn. 2019 May 13;19:100150. doi: 10.1016/j.scog.2019.100150. eCollection 2020 Mar.

  PMID: 31832340 BACKGROUND

MeSH Terms

Conditions

Bipolar Disorder; Depressive Disorder, Major; Psychotic Disorders

Interventions

Lurasidone Hydrochloride

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Depressive Disorder; Schizophrenia Spectrum and Other Psychotic Disorders

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Ben W Hunter, MD

  Skyland Trail

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2024
• First Posted: March 25, 2024
• Study Start: April 15, 2024
• Primary Completion: January 22, 2025
• Study Completion: January 22, 2025
• Last Updated: May 4, 2025

Record last verified: 2024-03

Locations

US (1)