Major Depressive Disorder
Conditions
Interventions
None listed
Sponsors
Shiga University of Medical Science
Department of Psychiatry, Nihon University Kobe University Sleepwell Co.,Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who had insomnia and/or depressive episodes visited research institutes. 2) Participants comprehend the study description, and consent to the study participation by their own free will. As for the participant is a person under age, we need the consent in writing by a legally acceptable representative for their study participation.
Exclusion criteria
Exclusion criteria: 1) Organic brain disorders identified in the brain structural imaging including CT and MRI (taken within past 6 months). 2) Epileptic disorders. 3) Somatic disorders that may cause depressive symptoms such as hypothyroidism, Cushing disease, or SLE. 4) Neurotic disorders that may cause depressive symptoms such as Parkinson disease, Huntington disease, or multiple sclerosis. 5) Sleep apnea syndrome. 6) Disorderly sleep-wake pattern such as graveyard shift or shift-workers. 7) Pathological suicidal ideations and/or suicide attempts. 8) Past episodes of substance use disorder. 9) Addiction to illegal drugs (amphetamine, morphine, cocaine, cannabis, phencyclidine) by Triage test. 10) Prescribed central nervous stimulating drugs, opioid medications (Ritalin, Concerta, and opioids), Modafinil, steroids, and/or interferon. 11) Taking part in and will be going to take part in the other clinical trials during the study period. 12) Ruled unfit to the study participation by the principal investigator or a member of the research project.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The sleep EEG indices calculated by a basic rhythm analysis program 2. Total sleep time (TST), sleep latency (SL) sleep efficiency (SE), wake after sleep onset (WASO), stage 1 sleep, stage 2 sleep, slow wave sleep (SWS), REM sleep, REM latency, REM density, and time in bed (TIB) etc. | — |
Secondary
| Measure | Time frame |
|---|---|
| PHQ-9, BDI, HAM-D, AIS, STAI, PANSS, YMRS, MMSE, PSQI Demographic characteristics of participants, concurrent medications, clinical observations (Conventional and DSM-5 diagnoses) | — |
Countries
Japan
Contacts
Public ContactHiroshi Kadotani
Shiga University of Medical Science Department of Sleep and Behavioral Sciences
Outcome results
None listed