UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029268 |
|---|---|
| Receipt number | 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 02:55:21 |
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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
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
oyu-d612@med.akita-u.ac.jp
Sponsor or person
Institute
Department of Neuropsychiatry, Akita University Graduate School of Medicine, Akita, Japan.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033455
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