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Acute antidepressant effects and response predictors of wake therapy

Verification of acute antidepressant effects of wake therapy for a depressive episode and development of predictors of treatment response

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1030220427
Enrollment
60
Registered
2022-10-29
Start date
2022-09-14
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

A depressive episode in unipolar depressive disorder or bipolar disorder unipolar depression, bipolar disorder, depressive episode

Interventions

Sleep deprivation therapy (wake therapy). During the intervention period, study subjects undergo three cycles of sleep manipulation, each cycle consisting of total sleep deprivation followed by recove
D012892
sleep deprivation therapy, wake therapy

Sponsors

Yoshiike Takuya
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Aged 20 years or older 2) Capable to provide informed consent 3) Presenting a depressive episode in the course of depressive disorder or bipolar disorder (DSM-5 criteria) 4) Admitted to our hospital 5) A baseline Hamilton Rating Scale for Depression (17-item) score of 14 or higher

Exclusion criteria

Exclusion criteria: 1) Presenting psychotic features in the depressive episode 2) A score greater than 2 on the suicide item of the Hamilton Rating Score for Depression 3) A score greater than 2 on the agitation item of the Hamilton Rating Score for Depression 4) Severe personality disorder(s) 5) A history of drug or alcohol dependency or abuse within the last six months 6) A history of epilepsy 7) Receiving electroconvulsive therapy, repetitive transcranial magnetic stimulation, or cognitive-behavioral therapy 8) Pregnancy 9) Major medical and neurological disorders

Design outcomes

Primary

MeasureTime frame
Change in the score of the Hamilton Rating Scale for Depression

Secondary

MeasureTime frame
Change in the score or value of the following measures: Quick Inventory of Depressive Symptomatology, Young Mania Rating Scale, Visual Analogue Scale (mood, sleepiness), Clinical Global Impression, time perception, Insomnia Severity Index, Epworth Sleepiness Scale, Magnetic Resonance Imaging variables, electroencephalographic variables, actigraphic variables, general cognition (THINC-it), peripheral blood inflammatory variables, clock gene polymorphism

Contacts

Public ContactTakuya Yoshiike

National Center of Neurology and Psychiatry

yoshiike@ncnp.go.jp+81-42-346-2071

Outcome results

None listed

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