Daytime hypersomnia and decreased quality of life associated with schizophrenia
Conditions
Interventions
Switching from prior therapy to lurasidone
Sponsors
Mishima Kazuo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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 (However, persons who are determined by an investigator or a sub-investigator to have their symptoms controlled by treatments, and whose impact on daytime sleepiness is limited, are excluded.) 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,maprotiline,zuranolone31,34) 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 h
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in JESS score after 12 weeks of treatment * | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 s | — |
Contacts
Public ContactKazuo Mishima
Akita Universitiy Hospital
Outcome results
None listed