NIPH Clinical Trials Search

RISE Study

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Patients with bipolar depression accompanied by difficulties in waking up
Date of first enrollment	24/04/2026
Target sample size	30
Countries of recruitment
Study type	Interventional
Intervention(s)	Evaluate the effects of administering lurasidone to patients with bipolar disorder experiencing difficulties in waking up caused by depressive episodes. The principal investigator or the co-investigators will prescribe lurasidone openly during the treatment phase of the study. The starting dose of lurasidone will be 20 mg/day, and if deemed tolerable by the principal investigator or co-investigators, it may be increased up to 60 mg/day. However, the daily dose shall not exceed 60 mg.

Outcome(s)

Primary Outcome

- Change in wake-up time from baseline to 8 weeks after starting treatment (Fitbit)

Secondary Outcome

Changes from baseline in the Epworth Sleepiness Scale (JESS) total score and sub-item scores at each evaluation time point Changes from baseline in the Insomnia Severity In dex (ISI-J) total score and sub-item scores at each evaluation time point Changes from baseline in the Hamilton Depression Rating Scale (HAM-D17) total score and sub-item scores at each evaluation time point Changes from baseline in the Young Mania Rating Scale (YMRS) total score and sub-item scores at each evaluation time point Changes from baseline in the Hamilton Anxiety Rating Scale (HAM-A) total score and sub-item scores at each evaluation time point Changes from baseline in the Subjective Cognitive Assessment (COBRA) total score and sub-item scores 8 weeks after the start of treatment Changes from baseline in the Sheehan Disability Scale (SDS) total score and sub-item scores 8 weeks after the start of treatment Change from baseline based on Fitbit measurement data for the 7 days immediately before each visit after the start of treatment Change from baseline based on deep body temperature measurement data for the 7 days immediately before each visit after the start of treatment

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	<= 50age old
Gender	Both
Include criteria	1)Outpatients aged 18 to 50 years at the time of consent. 2)Meet the diagnostic criteria for bipolar disorder according to DSM-5-TR. 3)Meet the HAM-D17 total score of 8 or greater at both screening and baseline. 4)Meet the YMARS total score of 12 or less at both screening and baseline. 5) Meet the diagnostic criteria for circadian rhythm sleep-wake disorders according to DSM-5-TR and experience delayed sleep phase symptoms for at least one month. 1. Persistent or recurrent sleep disruption, primarily due to alterations in circadian mechanisms or a mismatch between endogenous circadian rhythms and the sleep-wake schedule dictated by the individual's physical environment or social or occupational schedule. 2. The sleep disruption results in excessive sleepiness, insomnia, or both. 3. The sleep disturbance causes clinically significant distress or impairment in social, occupational, or other important areas of functioning. G47.21 Delayed Sleep Phase: A pattern in which sleep onset and wake times are delayed, resulting in an inability to fall asleep and wake at desired or customarily accepted early times. The diagnostic feature of delayed sleep phase is primarily based on the clinical condition of a primary sleep phase (usually two or more hours) being delayed in relation to the desired sleep-wake time, resulting in symptoms such as insomnia and excessive sleepiness. 6) If the research subject and their female partner are of childbearing potential, they agree to prevent pregnancy using appropriate contraception. 7) Individuals who have been fully informed of the purpose, content, anticipated benefits, and risks of this study and have provided written informed consent to participate in the study. 8) Individuals who are judged by the principal investigator or co-investigator to be able to understand the content of this study and comply with its provisions.
Exclude criteria	1) Rapid cycling type of bipolar disorder 2) Individuals who cannot be treated according to the package insert for lurasidone 3) Individuals who have been treated with lurasidone within 12 weeks prior to the start of screening 4) Individuals working shift work that involves night shifts 5) Individuals who have been confirmed to have moderate to severe obstructive sleep apnea or who are deemed suspected to have such a condition by the principal investigator or co-investigator 6) Individuals who have central hypersomnia, sleep-related movement disorder, or parasomnia or who are deemed suspected to have such a condition by the principal investigator or co-investigator 7) Individuals who are deemed suspected to have drug-induced somnolence by the principal investigator or co-investigator 8) Individuals with substance use disorder (excessive intake of opioids, cannabinoids, or other illegal drugs, alcohol, or caffeine [as determined by the principal investigator or co-investigator], or recreational use of antipsychotics) 9) Individuals who have changed their mood disorder treatment (new medication, change in dosage) within 2 weeks prior to the start of screening 10)Those who have taken the following prohibited concomitant medications within 2 weeks prior to the start of screening:Antipsychotics 11) Those who have received the following prohibited concomitant therapies within 2 weeks prior to the start of screening:Electroconvulsive therapy (ECT), repetitive transcranial magnetic stimulation (rTMS) and other neuromodulation therapies, cognitive behavioral therapy (CBT), cognitive behavioral therapy for insomnia (CBT-I), chronotherapy (hospitalization, etc.), bright light therapy 12) Those who have used the following restricted concomitant medications in excess of the limit within 2 weeks prior to the start of screening:Concurrent use of three or more types of benzodiazepine receptor agonists 13) Those who are judged to be at imminent risk of suicide or harm to themselves or others 14) Those who have strong suicidal ideation or have had suicidal ideation for at least the past 4 weeks from the date of consent acquisition 15) Those who have a score of 3 or more on the suicide item of the HAM-D17 assessment scale at screening and baseline 16) Those with chronic diseases that are unstable, such as those requiring a change in medication 17) Those with acute diseases that require treatment 18)Those with a history of intracranial disease or central nervous system disease (e.g., stroke, traumatic brain injury, epilepsy, Parkinson's disease, etc.) 19) Those with serious physical illnesses 20) Pregnant women or women who wish to become pregnant 21) Those who are deemed inappropriate for participation in this study by the principal investigator or co-investigator due to the possibility of affecting safety or the evaluation items of this study