Bipolar DisorderNCT06328140
Sleep Quality, Cognitive Performance, and Computerized Cognitive Training
An observational study of Bipolar Disorder and Major Depressive Disorder, run by George West Mental Health Foundation d/b/a Skyland Trail at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder, Major Depressive Disorder, Psychosis
- What is being tested?
- Lurasidone and FDA Approved antidepressant treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2024to 22 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Sampled from consecutive admissions to residential treatment at Skyland Trail.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
George West Mental Health Foundation, DBA Skyland Trail
Atlanta, Georgia, 30329
About this study
Official title: Sleep Quality, Cognitive Performance, and Computerized Cognitive Training Comparison of Patients Treated With Lurasidone vs.Patients With Major Depression Receiving Selective Serotonin Reuptake Inhibitor(SSRI) Treatment as Usual
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.
Read more
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.
Read the detailed description
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.
These impairments in daytime cognition seem most significant in areas relevant to daytime learning and nighttime memory consolidation, which has important implications for the success of rehabilitation focused psychiatric treatments. These treatments are learning based and functional and social skills are trained with teaching, which cannot be successful in the presence of significant memory consolidation problems. Reduced levels of slow wave sleep are likely to lead to problems in the consolidation of information presented for learning.
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. These impairments could lead either to failures to concentrate during the daytime or failures to consolidate at night. As a result, the commonly expected benefits on neuroplasticity associated with CCT may be interrupted by poor sleep and this may lead to reduced benefits associated with combined skills training and CCT interventions.
In addition to the adverse effects of impaired sleep on consolidation and daytime alertness, there are multiple ways that these processes can be disrupted pharmacologically through several different factors. Increased anticholinergic load can 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 a previous study, treatment with Quetiapine was previously found to induce substantial sleepiness and was associated with essentially no practice related improvements in cognition across 4 assessment time periods In contrast, Lurasidone was associated with reductions in sleepiness and with cognitive gains that exceeded practice effects. Thus, some of the differences in cognitive performance between quetiapine and Lurasidone could be due to sleep disturbance, in addition to the intrinsic benefits of lurasidone on cognition. One viable hypothesis is that Lurasidone has both direct beneficial effects on cognition and 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 baseline cognitive performance, measurement of treatment-related gains, and wearable devices.
The assessments goals would be to measure nighttime sleep, engagement in CCT, and cognitive gains over the study period. The primary outcome is cognitive gains with training over the treatment period.
- Conditions
- Bipolar Disorder, Major Depressive Disorder, Psychosis
- Being tested
- Lurasidone, FDA Approved antidepressant treatment
- Medical subject headings
- Bipolar Disorder, Depressive Disorder, Major, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LurasidoneDrug
Daily medication treatment
FDA Approved antidepressant treatmentDrug
Also called Any FDA Approved antidepressant
Daily treatment with an FDA approved antidepressant
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: FDA Approved antidepressant treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to 8 weeks of treatment
Secondary outcomes (2)
Training Engagement in Cognitive training
Numbers of levels mastered per training day
Measured: Baseline to 8 weeks of treatment
Nighttime sleep measured with actigraphy
Minutes of daily sleep indexed by a Fit-Bit Actigraph
Measured: Baseline to 8 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start15 Apr 2024
- Primary completion22 Jan 2025
- Study completion22 Jan 2025
Why it stopped: we were unable to recruit participants according to the original protocol specifications. The sponsor would not allow for a modification so the study was stopped.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- George West Mental Health Foundation d/b/a Skyland Trail
- Sponsor type
- University, hospital or other
- Collaborators
- Sumitomo Pharmaceuticals America
- Responsible party
- Sponsor
- Investigators
- Ben W Hunter, MD, Principal investigator, Skyland Trail
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06328140
- Sponsor's protocol ID
- Skyland 001
- Status last verified
- Mar 2024
- First submitted
- 17 Mar 2024
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28740811Harvey 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.
PubMed 31832340
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Quality, Cognitive Performance, and Computerized Cognitive Training Comparison of Patients Treated With Lurasidone vs.Patients With Major Depression Receiving Selective Serotonin Reuptake Inhibitor(SSRI) Treatment as Usual
- ClinicalTrials.gov ID
- NCT06328140
- Acronym / sponsor ID
- Skyland 001
- Conditions
- Bipolar Disorder, Major Depressive Disorder, Psychosis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: we were unable to recruit participants according to the original protocol specifications. The sponsor would not allow for a modification so the study was stopped.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- George West Mental Health Foundation d/b/a Skyland TrailUniversity, hospital or other
- Collaborators
- Sumitomo Pharmaceuticals America
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 22 Jan 2025 (actual)
- Study completion
- 22 Jan 2025 (actual)
- First posted
- 25 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
These impairments in daytime cognition seem most significant in areas relevant to daytime learning and nighttime memory consolidation, which has important implications for the success of rehabilitation focused psychiatric treatments. These treatments are learning based and functional and social skills are trained with teaching, which cannot be successful in the presence of significant memory consolidation problems. Reduced levels of slow wave sleep are likely to lead to problems in the consolidation of information presented for learning.
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. These impairments could lead either to failures to concentrate during the daytime or failures to consolidate at night. As a result, the commonly expected benefits on neuroplasticity associated with CCT may be interrupted by poor sleep and this may lead to reduced benefits associated with combined skills training and CCT interventions.
In addition to the adverse effects of impaired sleep on consolidation and daytime alertness, there are multiple ways that these processes can be disrupted pharmacologically through several different factors. Increased anticholinergic load can 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 a previous study, treatment with Quetiapine was previously found to induce substantial sleepiness and was associated with essentially no practice related improvements in cognition across 4 assessment time periods In contrast, Lurasidone was associated with reductions in sleepiness and with cognitive gains that exceeded practice effects. Thus, some of the differences in cognitive performance between quetiapine and Lurasidone could be due to sleep disturbance, in addition to the intrinsic benefits of lurasidone on cognition. One viable hypothesis is that Lurasidone has both direct beneficial effects on cognition and 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 baseline cognitive performance, measurement of treatment-related gains, and wearable devices.
The assessments goals would be to measure nighttime sleep, engagement in CCT, and cognitive gains over the study period. The primary outcome is cognitive gains with training over the treatment period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lurasidone Treatment | – | Drug: LurasidonePatients 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. |
| Treatment as usual for major depression | – | Drug: FDA Approved antidepressant treatmentPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Sampled from consecutive admissions to residential treatment at Skyland Trail.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LurasidoneDaily medication treatment | Drug | Lurasidone Treatment |
| FDA Approved antidepressant treatmentAlso: Any FDA Approved antidepressantDaily treatment with an FDA approved antidepressant | Drug | Treatment as usual for major depression |
Primary outcome
Improvement in Cognitive Performance
Time frame: Baseline to 8 weeks of treatment
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
2 secondary outcomes
Training Engagement in Cognitive training
Time frame: Baseline to 8 weeks of treatment
Nighttime sleep measured with actigraphy
Time frame: Baseline to 8 weeks of treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Background: PubMed 28740811Harvey 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.
- Background: PubMed 31832340Harvey 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ben W Hunter, MD principal investigator
Skyland Trail
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder and Major Depressive Disorder, run by George West Mental Health Foundation d/b/a Skyland Trail at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Cognitive Performance (time frame: Baseline to 8 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06328140, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2025.