Acute antidepressant effects and response predictors of wake therapy

JRCT ID: jRCT1030220427

Registered date:29/10/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: A depressive episode in unipolar depressive disorder or bipolar disorder
• Date of first enrollment: 14/09/2022
• Target sample size: 60
• Study type: Interventional
• Intervention(s): 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 recovery sleep. More specifically, subjects will voluntarily maintain wakefulness during the 36-hour (7:00 am to 7:00 pm the next day) waking period, which includes total sleep deprivation, and recovery sleep during the 12-hour (7:00 pm to 7:00 am the next day) sleep period.

Outcome(s)

• Primary Outcome: Change in the score of the Hamilton Rating Scale for Depression
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Yoshiike Takuya