Practical use of sleep EEG for objective assessment and diagnosis of major depression - Multicenter exploratory prospective study

Not Applicable

• Conditions: Major Depressive Disorder

• Registration Number: JPRN-UMIN000026835
• Lead Sponsor: Shiga University of Medical Science

Brief Summary

183 cases registered. There were 176 cases analyzed.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-04-03
• Study Completion: 2019-01-23
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 183

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
PHQ-9, BDI, HAM-D, AIS, STAI, PANSS, YMRS, MMSE, PSQI Demographic characteristics of participants, concurrent medications, clinical observations (Conventional and DSM-5 diagnoses)