A pilot study for the efficacy of the non-benzodiazepine hypnotic or orexin receptor antagonist on insomnia in major depressive patients unresponsive to benzodiazepine hypnotic treatment: a randomized open-label trial.

A pilot study for the efficacy of the non-benzodiazepine hypnotic or orexin receptor antagonist on insomnia in major depressive patients unresponsive to benzodiazepine hypnotic treatment: a randomized open-label trial. - A pilot study for the efficacy of the non-benzodiazepine hypnotic or orexin receptor antagonist on insomnia in major depressive patients unresponsive to benzodiazepine hypnotic treatment: a randomized open-label trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000031032

Enrollment

Registered

2018-01-29

Start date

2018-04-01

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

major depressive disorder

Interventions

Switching benzodiazepine to eszopiclone (1-3 mg/day) Switching benzodiazepine to suvorexant (15-20 mg/day)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Major depressive patients with insominia unresponssive to the treatment with benzodiazepine for at least 2 weeks.

Exclusion criteria

Exclusion criteria: 1. Patients taking other hypnotics. 2. Patients judged not to be accurately taken. 3. Patients with severe physical disease. 4. Patients with a history of severe drug hypersensitivity or drug allergy. 5. Women who are pregnant or who wish to be pregnant during the study period, and lactating mother. 6. Patients taking agents causing insomnia. 7. Patients judged to be high-risk for substance abuse. 8. Patients judged to be high risk for suicide. 9. Patients judged to be inappropriate for participation by researchers.

Design outcomes

Primary

Measure	Time frame
The mean change in ISI and PSQI total scores from baseline at weeks 2 and 4.	—

Secondary

Measure	Time frame
1. The rate of remission in ISI and PSQI at 4 weeks. 2. The mean change in 6 components in PSQI scores from baseline at weeks 2 and 4; sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance and daytime dysfunction. 3. The mean change in BDI total scores from baseline at weeks 2 and 4. 4. The mean change in each items scores of BDI from baseline at weeks 4. 5. The mean change in DSST and DS scores from baseline at week 4. 6. The mean change in GAD-7 total scores from baseline at weeks 2 and 4. 7. The mean change in ISI and PSQI scores for each anxiety symptom from baseline at weeks 2 and 4.	—

Measure

Time frame

1. The rate of remission in ISI and PSQI at 4 weeks. 2. The mean change in 6 components in PSQI scores from baseline at weeks 2 and 4; sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance and daytime dysfunction. 3. The mean change in BDI total scores from baseline at weeks 2 and 4. 4. The mean change in each items scores of BDI from baseline at weeks 4. 5. The mean change in DSST and DS scores from baseline at week 4. 6. The mean change in GAD-7 total scores from baseline at weeks 2 and 4. 7. The mean change in ISI and PSQI scores for each anxiety symptom from baseline at weeks 2 and 4.

—

Countries

Japan

Contacts

Public ContactYuki Shigetsura

Kyoto University Hospital Department of Clinical Pharmacology and Therapeutics

sigetura@kuhp.kyoto-u.ac.jp075-751-3581

Outcome results

None listed

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