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
Trial comparing Lurasidone to standard antidepressants for depression and bipolar disorder
Plain English Summary
Sleep Quality, Cognitive Performance, and Computerized Cognitive Training is a Not Applicable clinical trial sponsored by George West Mental Health Foundation d/b/a Skyland Trail studying Bipolar Disorder, Major Depressive Disorder, Psychosis. This study compares Lurasidone to standard antidepressant treatments (SSRIs) in patients with major depression or bipolar disorder. It aims to see if Lurasidone improves sleep quality and cognitive function compared to other treatments. Participants will undergo cognitive training and have their sleep monitored. Patients not eligible for this trial might consider other FDA-approved antidepressants or psychotherapy.
Official 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 t
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults diagnosed with major depression or bipolar disorder who have shown some cognitive difficulties. Individuals must be able to provide informed consent and plan to stay at the facility for at least 8 weeks. People with neurological conditions like stroke or seizures, significant sensory impairments, or those currently taking specific antidepressants (vortioxetine or tricyclic antidepressants) cannot participate. This trial is studying Bipolar Disorder, Major Depressive Disorder, Psychosis, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures how much participants' thinking abilities improve over 8 weeks of treatment, indicating whether the medication helps with cognitive challenges. The specific primary outcome measures are: Improvement in Cognitive Performance (Baseline to 8 weeks of treatment). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial is important because it investigates if Lurasidone can improve both sleep and thinking abilities in patients with depression and bipolar disorder, addressing a gap in treatments that often This research targets Bipolar Disorder, Major Depressive Disorder, Psychosis, where improved treatment options are needed.
Investor Insight
This trial, though withdrawn, signals interest in Lurasidone's potential for cognitive enhancement in psychiatric conditions, a market with significant unmet needs.
Is This Trial Right for Me?
Ask your doctor if Lurasidone is a suitable option for you and how it compares to your current treatment. Participation involves regular medication, cognitive training exercises, and sleep monitoring using a device. Be prepared for regular assessments of your sleep and thinking skills throughout the study. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: OBSERVATIONAL
Interventions
- DRUG: Lurasidone — Daily medication treatment
- DRUG: FDA Approved antidepressant treatment — Daily treatment with an FDA approved antidepressant
Primary Outcomes
- Improvement in Cognitive Performance (Baseline to 8 weeks of treatment)
Secondary Outcomes
- Training Engagement in Cognitive training (Baseline to 8 weeks of treatment)
- Nighttime sleep measured with actigraphy (Baseline to 8 weeks of treatment)
Full Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
- George West Mental Health Foundation, DBA Skyland Trail, Atlanta, Georgia, United States
Frequently Asked Questions
What is clinical trial NCT06328140?
NCT06328140 is a Not Applicable OBSERVATIONAL study titled "Sleep Quality, Cognitive Performance, and Computerized Cognitive Training." It is currently withdrawn and is sponsored by George West Mental Health Foundation d/b/a Skyland Trail.
What conditions does NCT06328140 study?
This trial investigates treatments for Bipolar Disorder, Major Depressive Disorder, Psychosis. The primary condition under study is Bipolar Disorder.
What treatments are being tested in NCT06328140?
The interventions being studied include: Lurasidone (DRUG), FDA Approved antidepressant treatment (DRUG). Daily medication treatment
What does Not Applicable mean for NCT06328140?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT06328140?
This trial is currently "Withdrawn." It started on 2024-04-15. The estimated completion date is 2025-01-22.
Who is sponsoring NCT06328140?
NCT06328140 is sponsored by George West Mental Health Foundation d/b/a Skyland Trail. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How is NCT06328140 designed?
This is a observational study.
What are the primary outcomes being measured in NCT06328140?
The primary outcome measures are: Improvement in Cognitive Performance (Baseline to 8 weeks of treatment). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06328140 being conducted?
This trial is being conducted at 1 site, including Atlanta, Georgia (United States).
Where can I find official information about NCT06328140?
The official record for NCT06328140 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06328140. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06328140 testing in simple terms?
This study compares Lurasidone to standard antidepressant treatments (SSRIs) in patients with major depression or bipolar disorder. It aims to see if Lurasidone improves sleep quality and cognitive function compared to other treatments.
Why is this trial significant?
This trial is important because it investigates if Lurasidone can improve both sleep and thinking abilities in patients with depression and bipolar disorder, addressing a gap in treatments that often
What are the potential risks of participating in NCT06328140?
Potential side effects of Lurasidone may include drowsiness, nausea, or dizziness. Cognitive training may cause temporary fatigue or frustration. The study is observational, meaning it monitors existing treatments rather than testing a new intervention directly. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06328140?
Ask your doctor if Lurasidone is a suitable option for you and how it compares to your current treatment. Participation involves regular medication, cognitive training exercises, and sleep monitoring using a device. Be prepared for regular assessments of your sleep and thinking skills throughout the study. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06328140 signal from an investment perspective?
This trial, though withdrawn, signals interest in Lurasidone's potential for cognitive enhancement in psychiatric conditions, a market with significant unmet needs. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will undergo cognitive training and have their sleep monitored. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.