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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029268
Receipt No. R000033455
Scientific Title A prospective, open labeled, flexible-dose and 4-8 week design study for the efficacy and tolerability of aripiprazole for treating patients who were previously treated but who had an inadequate response to their current delayed sleep phase syndrome and hypersomnolence disorder.
Date of disclosure of the study information 2017/10/01
Last modified on 2018/10/16

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Basic information
Public title A prospective, open labeled, flexible-dose and 4-8 week design study for the efficacy and tolerability of aripiprazole for treating patients who were previously treated but who had an inadequate response to their current delayed sleep phase syndrome and hypersomnolence disorder.
Acronym Aripiprazole for treating patients with delayed sleep phase syndrome and hypersomnolence disorder.
Scientific Title A prospective, open labeled, flexible-dose and 4-8 week design study for the efficacy and tolerability of aripiprazole for treating patients who were previously treated but who had an inadequate response to their current delayed sleep phase syndrome and hypersomnolence disorder.
Scientific Title:Acronym Aripiprazole for treating patients with delayed sleep phase syndrome and hypersomnolence disorder.
Region
Japan

Condition
Condition Delayed sleep phase syndrome and hypersomnolence disorder.
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Delayed sleep phase syndrome (DSPS), a sleep disorder where a patient's circadian rhythm is delayed from typical day/night cycle, usually begins in the second decade of life or earlier (Thorpy et al.,1988). DSPS is characterized by habitual sleep-wake timing that is delayed, usually more than two hours, relative to conventional or socially acceptable timing (ICSD-3). Affected individuals complain of difficulty falling asleep at a socially acceptable time, as required to obtain sufficient sleep duration on a school or work night. These individuals also experience difficulty arising at a socially acceptable wake time, as required to prepare for school or work. When allowed to follow his or her preferred schedule, the patient's timing of sleep is delayed (ICSD-3). Three types of treatments are available for DSPS: chronotherapy, phototherapy, and exogenous melatonin administration (Crowley et al.,2007, Okawa and Uchiyama, 2007). Although, anti-psychotics have not been reported in the treatment of DSPS, aripiprazole (APZ), which is a second generation antipsychotic, manifests a novel mechanism of action by serving as a partial agonist of D2 receptors (Shapiro et al.,2003). Depression is reported to be the most common psychopathology associated with DSPS (Okawa and Uchiyama, 2007), and low dose APZ is reported to be effective in major depressive disorder as adjunctive therapy (Marcus et al.,2008). Therefore, we tried to treat depressive symptoms of DSPS, then, we found the improvement of DSPS and prolonged nocturnal sleep time (Takaki and Ujike, 2014). Subsequently, we extended to investigate low dose APZ for patients with hypersomnolence disorder in this study.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Total sleep time at 1-2-4 weeks.
Key secondary outcomes Side effects at 1-2-4 weeks.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Study period: 4-8 weeks, amount of medication: aripiprazole 0.5-3mg/day, once a day.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients who were delayed sleep phase syndrome or hypersomnolence disorders.
Key exclusion criteria Patients who do not obtain consent.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuki Omori
Organization Akita University Graduate School of Medicine, Akita, Japan.
Division name Department of Neuropsychiatry
Zip code
Address 1-1-1, Hondo, Akita city, Akita, Japan
TEL 018-884-6122
Email oyu-d612@med.akita-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuki Omori
Organization Akita University Graduate School of Medicine, Akita, Japan.
Division name Department of Neuropsychiatry
Zip code
Address 1-1-1, Hondo, Akita city, Akita, Japan
TEL 018-884-6122
Homepage URL
Email oyu-d612@med.akita-u.ac.jp

Sponsor
Institute Department of Neuropsychiatry, Akita University Graduate School of Medicine, Akita, Japan.
Institute
Department

Funding Source
Organization Self
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The subjects were prescribed initially 0.5-3.0 mg of APZ once a day with subsequent dose adjustments. Total sleep time was reduced average 1.6 hour. The subjects woke up average 1.8 hour earlier in the morning and nocturnal sleep onset changed average 0.6 hour earlier. Low dose APZ reduced nocturnal sleep time and the change of sleep offset in the subjects who had prolonged sleep time and DSPS. The mechanism of action would be dopaminergic up regulation due to dopamine D3 agonistic activity. Since it is difficult for physicians to treat prolonged sleep time and DSPS, this medication would become a new therapeutic option for these patients.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 09 Month 30 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 30 Day
Last follow-up date
2018 Year 10 Month 15 Day
Date of closure to data entry
2018 Year 10 Month 15 Day
Date trial data considered complete
2018 Year 10 Month 15 Day
Date analysis concluded
2018 Year 10 Month 15 Day

Other
Other related information

Management information
Registered date
2017 Year 09 Month 24 Day
Last modified on
2018 Year 10 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033455

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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