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Observational study of the effect of aripiprazole on waking difficulty

Observational study of the effect of aripiprazole on waking difficulty - Observational study of the effect of aripiprazole on waking difficulty

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000048309
Enrollment
12
Registered
2022-07-10
Start date
2020-12-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient being treated for depression with difficulty waking up for which aripiprazole was prescribed

Interventions

None listed

Sponsors

Kurume University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients who have been diagnosed with major depressive disorder by DSM-V (Diagnostic and Statistical Manual of Disorders) and being treated with antidepressants. 2. Willingness and ability to follow the procedures of this study, including response to wearing the actigraph and consent to information collection. (In the case of minors, consent will be obtained from parents and guardians.)

Exclusion criteria

Exclusion criteria: 1. Patients witha history of serious psychosomatic disorders. 2. Patients with a history of suicidal ideation or attempts. 3. Patients taking aripiprazole with contraindications or precautions. 4. Pregnant women, patients who may become pregnant, patients who wish to become pregnant, and lactating patients. 5. Patients who are deemed incapable of consenting to research. 6. Patients who are otherwise classified as unfit by the attending physicians for the research.

Design outcomes

Primary

MeasureTime frame
Aripiprazole is administered for 28 days, and actigraph and PSG are performed before and after administration. Actigraphic and PSG data will be investigated.

Secondary

MeasureTime frame
1,Japanese version of Karolinska. Sleepiness Scale:State of sleepiness 2,Visual Analog Scale: Difficulty falling asleep, awakening in the middle of the day, difficulty sleeping soundly, mood, evaluation of sleepiness 3,Epworth sleepiness Scale: Subfective sleep quality 4,the Japanese version of the Pittsburgh Sleep Quality Index: Subjective sleep quality severity

Countries

Japan

Contacts

Public ContactHayato Ohshima

Kurume University School of Medicine Department of Neuropsychiatry

ohshima_hayato@med.kurume-u.ac.jp0942-31-7564

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026