Skip to content

Effects of Lemborexant on insomnia in patients with schizophrenia : A randomized controlled study

Effects of Lemborexant on insomnia in patients with schizophrenia : A randomized controlled study - Effects of Lemborexant on insomnia in patients with schizophrenia : A randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000049310
Enrollment
100
Registered
2022-11-01
Start date
2022-10-25
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

Insomnia in patients with schizophrenia

Interventions

Administration of 5 mg of Lemborexant for 14 days 14 days of placebo administration

Sponsors

Department of Psychiatry, Kurita Hospital, 695 Kurita Nagano-City Nagano, Japan, 380-0921
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Satisfy DSM5 diagnostic criteria for schizophrenia 2. Being treated in Kurita hospital 3.Those aged between 20 and 70. 4.Satisfy DSM5 diagnostic criteria for insomnia. 5.Using one or less benzodiazepines. 6.Not taking orexin receptor antagonists.

Exclusion criteria

Exclusion criteria: 1.Coexisting with mood disorder, anxiety disorder, drug addiction, or personality disorder. 2.Suffering from serious physical diseases such as cerebrovascular disease, heart disease, renal dysfunction, and neurological disease. 3.Coexisting with other sleep disorders such as hypersomnia, sleep-related breathing disorders, circadian rhythm sleep disorders, parasomnia, and sleep-related movement disorders. 4.Actigraphy cannot be performed safely.

Design outcomes

Primary

MeasureTime frame
Sleep variables obtained from actigraphs. Comparison between the 7-day pre-observation period and the 7th to 13th days after the intervention.

Secondary

MeasureTime frame
Association between change from baseline in sleep variables obtained from Actigraphs and blood orexin A levels at night.

Countries

Japan

Contacts

Public ContactYusuke Arai

Kurita Hospital Department of Psychiatry

y-arai@shinshu-u.ac.jp+81-262-26-1311

Outcome results

None listed

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