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Verification of the effect of lurasidone on daytime sleepiness in schizophrenia.

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Daytime hypersomnia and decreased quality of life associated with schizophrenia
Date of first enrollment	24/06/2025
Target sample size	39
Countries of recruitment
Study type	Interventional
Intervention(s)	Switching from prior therapy to lurasidone

Outcome(s)

Primary Outcome

Change from baseline in JESS score after 12 weeks of treatment *

Secondary Outcome

Main secondary endpoints > Change from baseline in attention, speed of processing, reasoning and problem solving of MCCB-J scores after 12 weeks of treatment > Change from baseline in objective sleepiness (mean sleep latency [SOLMSLT]) based on the Multiple Sleep Latency Test ( MSLT) after 12 weeks of treatment Other secondary endpoints Clinical evaluation > Change from baseline in attention, speed of processing, reasoning and problem solving of MCCB-J subtotal score after 12 weeks of treatment > Change from baseline in Brief Psychiatric Symptom Rating Scale (BPRS) total score and subitem scores at each evaluation time point > Change from baseline in Clinical Global Impressions-Severity (CGI-S) at each assessment time point > Change from baseline in the Insomnia Severity Index (ISI-J) total score and subitem scores at 12 weeks post-treatment > Change from baseline in Cognitive Hyperaroousal Scale (HAS-J) total score and subitem scores after 12 weeks of treatment > Change from baseline in the Subjective Well-being Under Neuroleptics (SWNS-J) total score and subitem scores at 12 weeks post-treatment > Change from baseline in the Global Assessment of Functioning (GAF) score after 12 weeks of treatment > Percentage of study subjects who successfully switched from main drug to lurasidone > Percentage of study subjects with a JESS score of 10 or less at each time point > Percentage of study subjects with a JESS score of 7 or less at each time point > Percentage of study subjects with a JESS score of 5 or less at each evaluation time point Device Evaluation The change from baseline (2-week data during the observation period) in the following items based on Fitbit measurement data during the 7 days immediately before each visit after the start of treatment > Sleep onset latency [obj-SOL] > Wake after sleep onset [obj-WASO] > Number of awakenings [obj-WT] > total sleep time [obj-TST]Total Sleep Time [obj-TST] > Sleep efficiency [obj-SE] > REM sleep percentage > Non-REM sleep percentage > Average daily wear rate of Fitbit during the 7 days immediately before each visit after the start of treatment > The change from baseline (2-week score during the observation period) in the following items based on ePRO's VAS score during the 7 days immediately prior to each visit after the start of treatment: - subjective mood score - subjective anxiety score - subjective volition score > Change from baseline (2-week data during the observation period) in the following items based on ePRO electronic sleep diary data for the 7 days immediately prior to each visit after the start of treatment : - subjective alertness score - sleep onset latency [sj-SOL] - Wake after sleep onset [sj-WASO] - Number of awakenings [sj-WT] - Total sleep time [sj-TST] - Sleep efficiency [sj-SE] > Number of days of ePRO responses in the 7 days immediately prior to each visit after the start of treatment. Exploratory endpoints According to the statistical analysis plan to be determined in the future. As assumed items, the following sleep, rhythm, and autonomic parameters and their change from baseline (2-week data during the observation period) during the entire post-treatment period will be measured and exploratory analysis is performed to determine whether there is a composite contribution or correlation to changes in clinical symptom evaluation (various clinical evaluations) such as excessive daytime sleepiness and cognitive function. Exploratory extraction of features is performed using statistical methods such as machine learning and other outsourced services to evaluate potential related factors to the primary or secondary endpoints. 1) Objective sleep parameters at home based on Fitbit (sleep onset latency [obj-SOL], wake time after sleep onset [obj-WASO], number of awakenings [obj-WT], total sleep time [obj-TST] and sleep efficiency [obj-SE]) 2) Heart rate data, respiration data, step count, blood oxygen level, heart rate variability, etc from Fitbit 3) ePRO subjective mood score, subjective anxiety score, and subjective volition score 4) ePRO subjective sleep parameters at home (Subjective arousal score, sleep latency [sj-SOL], duration of awakening [sj-WASO], frequency of awakening [sj-WT], total sleep time [sj-TST], and sleep efficiency [sj-SE]) 5) PULSOX ODI 6) MSLT EEG data 7) Others Safety endpoints 1)Adverse events 2)Serious adverse events 3)Vital signs (body temperature, blood pressure (sitting position)) and height, weight, BMI 4)Laboratory values (blood biochemical tests: AST (GOT), ALT (GPT), G-GTP, total bilirubin, cholesterol (total cholesterol, LDL cholesterol), triglycerides, BUN, creatinine, CPK, prolactin, HbA1c, albumin) 5)Change from baseline in the DIEPSS total score and subitem scores at each assessment time point 6)C-SSRS at each evaluation period 7)Adverse events that led to discontinuation of treatment

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	< 70age old
Gender	Both
Include criteria	1) Male and female patients aged between 18 and 69 years at the time of obtaining consent 2) Patients in outpatient treatment 3) Patients who meet the diagnostic criteria for schizophrenia in the DSM-5-TR 4) Patients who have a Japanese version of the Epworth Sleepiness Scale (JESS) score of 8 or higher at both screening and baseline term 5) Patients whose psychiatric symptoms are judged by the principal investigator or sub-investigators to be clinically stable (no evidence of acute exacerbation) for at least 8 weeks prior to the start of screening and during the observation period 6) Patients who have been fully informed of the purpose, content, anticipated benefits, and risks of the study, and who have given their written consent to participate in the study 7) Patients who have been judged by the principal investigator or sub-investigators to be capable of understanding and complying with the content of this research
Exclude criteria	1) Patients who cannot be treated in accordance with the lurasidone package insert 2) Patients who have received treatment with lurasidone within 12 weeks prior to the start of screening 3) Patients with a pre-onset estimated IQ of less than 70 on the Japanese Adult Reading Test (JART)25 4) Patients who work rotating shifts involving night shifts 5) Patients with a confirmed moderate or higher degree of obstructive sleep apnea, or patients suspected of having obstructive sleep apnea such as 3% ODI of 15 or higher on pulse oximetry, as judged by the principal investigator or sub-investigators 6)Patients with central hypersomnia, sleep-related movement disorders, parasomnias, or circadian rhythm sleep-wake disorders patients who are judged by the principal investigator or sub-investigators to have or be suspected of having such a disorder 7) Patients who have undergone MCCB-J assessments within 12 weeks prior to the start of screening term 8) Patients who have a mean sleep duration of less than 5 hours in the 4 weeks prior to the start of screening term 9) Patients who cannot agree to discontinue the principle of discontinuing alcohol consumption 3 days prior to and on the day of testing at each assessment point 10) Patients who have received treatment with intractable injectable antipsychotics within 12 weeks prior to the start of screening term 11) Patients who were receiving treatment with clozapine at the time of obtaining consent 12) Patients who are using first-generation antihistamines (e.g. diphenhydramine, clemastine, dl-chlorpheniramine, d-chlorpheniramine, promethazine, alimemazine, hydroxyzine, homochlorcyclidine, cyproheptadine) at the time of obtaining consent 13) Patients who have a substance use disorder (overdose of opioids, cannabinoids or other illicit drugs, alcohol or caffeine [at the discretion of the principal investigator or sub-investigators], or recreational use of antipsychotic medications) 14) Patients who took any of the following prohibited concomitant medications or therapies in this study within 4 weeks prior to the start of screening term 1.Barbiturates,Sedating antidepressants (e.g. imipramine, clomipramine, amitriptyline, trazodone, mianserin, mirtazapine,trimipramine,maprotiline31,34) 2.Neuromodulation therapies such as electroconvulsive therapy (ECT) and repetitive transcranial magnetic stimulation (rTMS), Cognitive-behavioral therapy (CBT), Cognitive-behavioral therapy for insomnia (CBT-I) Cognitive rehabilitation therapy such as NEAR, 15) Patients who have taken the following medications for which concomitant use is restricted in this study within 4 weeks prior to the start of screening term 1.Total antipsychotic use exceeding 1,000 mg/day of CP equivalent 2.Use of anticholinergic drugs for the treatment of Parkinson's disease in excess of the equivalent of 3 mg/day of biperiden 3.Concomitant use of three or more drugs of the same type for any of the following: antipsychotic drugs, benzodiazepine receptor agonists, sleep modifying drugs for the treatment of insomnia(drugs judged by the principal investigator or sub-investigators to have been prescribed before bedtime for the purpose of regulating sleep), anxiolytics for the treatment of anxiety 16) Patients at risk of self-harm or other harm in the past 24 weeks from the date of consent 17) Patient with strong suicidal ideation or suicidal thoughts in at least last 4 weeks from the date of consent 18) Patient with a chronic illness whose condition is not stable, such as a condition requiring a change in medication 19) Patients with an acute illness that requiring treatment 20) Patients with a history of intracranial or central nervous system disease (e.g., stroke, traumatic brain injury, epilepsy, Parkinson's disease) 21) Patients with serious physical illnesses 22) Pregnant women or women who wish to become pregnant 23) Patients who have been judged by the principal investigator or sub-investigators to be ineligible to participate in this study because of potential effects on safety or on the endpoints of this study