Skip to content

The Study of Major Depressive Disorder Based on Mobile Measurement Technology

The Study of Major Depressive Disorder Based on Mobile Measurement Technology

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ROC-17013147
Enrollment
Unknown
Registered
2017-10-29
Start date
2017-10-31
Completion date
Unknown
Last updated
2017-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Interventions

Patients with mild to moderate depression:None
Patients with severe depression:None
Health control:None

Sponsors

Beijing Anding Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients with depressive disorder need to meet all criteria as following: 1. Outpatients or inpatients, aged at least 18 years and not more than 65 years, Male or female; 2. Has a diagnosis of major depressive disorder by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria (confirmed by MINI), without psychotic symptoms; 3. Systemic anti-depressants treatment were not adopted during current episode, or has taken no anti-depressants in last 14 days; 4. Total score of HAMD-17 = 14 at screening; 5. Has at least primary school education and can understand the scales; 6. Signed an informed consent form by patients. Health control need to meet all criteria as follow: 1. Aged 18 to 65 years Male or female; 2. Meet no diagnosis in Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria (confirmed by MINI); 3. Has at least primary school education and can understand the scales; 4. Signed an informed consent form by patients. ;Inclusion criteria: Patients with depressive disorder need to meet all criteria as following: 1. Outpatients or inpatients, aged at least 18 years and not more than 65 years, Male or female; 2. Has a diagnosis of major depressive disorder by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria (confirmed by MINI), without psychotic symptoms; 3. Systemic anti-depressants treatment were not adopted during current episode, or has taken no anti-depressants in last 14 days; 4. Total score of HAMD-17 = 14 at screening; 5. Has at least primary school education and can understand the scales; 6. Signed an informed consent form by patients. Health control need to meet all criteria as follow: 1. Aged 18 to 65 years Male or female; 2. Meet no diagnosis in Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria (confirmed by MINI); 3. Has at least primary school education and can understand the scales; 4. Signed an informed consent form by patients. ;Inclusion criteria: Patients with depressive disorder need to meet all criteria as following: 1. Outpatients or inpatients, aged at least 18 years and not more than 65 years, Male or female; 2. Has a diagnosis of major depressive disorder by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria (confirmed by MINI), without psychotic symptoms; 3. Systemic anti-depressants treatment were not adopted during current episode, or has taken no anti-depressants in last 14 days; 4. Total score of HAMD-17 = 14 at screening; 5. Has at least primary school education and can understand the scales; 6. Signed an informed consent form by patients. Health control need to meet all criteria as follow: 1. Aged 18 to 65 years Male or female; 2. Meet no diagnosis in Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria (confirmed by MINI); 3. Has at least primary school education and can understand the scales; 4. Signed an informed consent form by patients. ;Inclusion criteria: Patients with depressive disorder need to meet all criteria as following: 1. Outpatients or inpatients, aged at least 18 years and not more than 65 years, Male or female; 2. Has a diagnosis of major depressive disorder by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria (confirmed by MINI), without psychotic symptoms; 3. Systemic anti-depressants treatment were not adopted during current episode, or has taken no anti-depressants in last 14 days; 4. Total score of HAMD-17 = 14 at screening; 5. Has at least primary school education and can understand the scales; 6. Signed an informed consent form by patients. Health control need to meet all criteria as follow: 1. Aged 18 to 65 years Male or female; 2. Meet no diagnosis in Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria (confirmed by MINI); 3. Has at least primary school education and can understand the scales; 4. Signed an informed consent form by patients. ;Inclusion criteria: Patients with depressive disorder need to meet all criteria as following: 1. Outpatients or inpatients, aged at least 18 years and not more than 65 years, Male or female; 2. Has a diagnosis of major depressive disorder by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria (confirmed by MINI), without psychotic symptoms; 3. Systemic anti-depressants treatment were not adopted during current episode, or has taken no anti-depressants in last 14 days; 4. Total score of HAMD-17 = 14 at screening; 5. Has at least primary school education and can understand the scales; 6. Signed an informed consent form by patients. Health control need to meet all criteria as follow: 1. Aged 18 to 65 years Male or female; 2. Meet no diagnosis in Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria (confirmed by MINI); 3. Has at least primary school education and can understand the scales; 4. Signed an informed consent form by patients.

Exclusion criteria

Exclusion criteria: Patients meet any one of follow criteria should be excluded: 1. History of manic episode hypomania episode; 2. History of bipolar, schizophrenia, schizoaffective disorder, or other psychotic disorders; 3. History of drug and alcohol dependence or acute intoxication; 4. Women in pregnancy or lactation; 5. Has specific anxiety symptoms, total score of HAMA>14; 6. Significant risk of suicidal behaviors, with severe suicidal risk in MINI, or HAMD-17 Item 3(suicide) score =3; 7. History of independent sleep disorder (e.g. obstructive sleep apnea, narcolepsy, bruxism, periodic limb movement disorder, restless legs syndrome and so on); 8. Organic brain diseases; 9. History of head trauma induced unconsciousness more than one hour; or obvious mental retardation; 10. Current diseases which affect heart or respiratory, such as acute exacerbation of chronic obstructive pulmonary disease, acute exacerbation of asthma, sinus tachycardia, sinus bradycardia, arrhythmia and so on; 11. Current clinically significant disease. Health control meet any one of follow criteria should be excluded: 1. History of any diagnosis in Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria; 2. History of independent sleep disorder (e.g. obstructive sleep apnea, narcolepsy, bruxism, periodic limb movement disorder, restless legs syndrome and so on); 3. Current diseases which affect heart or respiratory, such as acute exacerbation of chronic obstructive pulmonary disease, acute exacerbation of asthma, sinus tachycardia, sinus bradycardia, arrhythmia and so on; 4. History of drug and alcohol dependence or acute intoxication; 5. Women in pregnancy or lactation; 6. Current clinically significant disease; 7. History of head trauma induced unconsciousness more than two minutes.;Exclusion criteria: Patients meet any one of follow criteria should be excluded: 1. History of manic episode hypomania episode; 2. History of bipolar, schizophrenia, schizoaffective disorder, or other psychotic disorders; 3. History of drug and alcohol dependence or acute intoxication; 4. Women in pregnancy or lactation; 5. Has specific anxiety symptoms, total score of HAMA>14; 6. Significant risk of suicidal behaviors, with severe suicidal risk in MINI, or HAMD-17 Item 3(suicide) score =3; 7. History of independent sleep disorder (e.g. obstructive sleep apnea, narcolepsy, bruxism, periodic limb movement disorder, restless legs syndrome and so on); 8. Organic brain diseases; 9. History of head trauma induced unconsciousness more than one hour; or obvious mental retardation; 10. Current diseases which affect heart or respiratory, such as acute exacerbation of chronic obstructive pulmonary disease, acute exacerbation of asthma, sinus tachycardia, sinus bradycardia, arrhythmia and so on; 11. Current clinically significant disease. Health control meet any one of follow criteria should be excluded: 1. History of any diagnosis in Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria; 2. History of independent sleep disorder (e.g. obstructive sleep apnea, narcolepsy, bruxism, periodic limb movement disorder, restless legs syndrome and so on); 3. Current diseases which affect heart or respiratory, such as acute exacerbation of chronic obstructive pulmonary disease, acute exacerbation of asthma, sinus tachycardia, sinus bradycardia, arrhythmia and so on; 4. History of drug and alcohol dependence or acute intoxication; 5. Women in pregnancy or lactation; 6. Current clinically significant disease; 7. History of head trauma induced unconsciousness more than two minutes.;Exclusion criteria: Patients meet any one of follow criteria should be excluded: 1. History of manic episode hypomania episode; 2. History of bipolar, schizophrenia, schizoaffective disorder, or other psychotic disorders; 3. History of drug and alcohol dependence or acute intoxication; 4. Women in pregnancy or lactation; 5. Has specific anxiety symptoms, total score of HAMA>14; 6. Significant risk of suicidal behaviors, with severe suicidal risk in MINI, or HAMD-17 Item 3(suicide) score =3; 7. History of independent sleep disorder (e.g. obstructive sleep apnea, narcolepsy, bruxism, periodic limb movement disorder, restless legs syndrome and so on); 8. Organic brain diseases; 9. History of head trauma induced unconsciousness more than one hour; or obvious mental retardation; 10. Current diseases which affect heart or respiratory, such as acute exacerbation of chronic obstructive pulmonary disease, acute exacerbation of asthma, sinus tachycardia, sinus bradycardia, arrhythmia and so on; 11. Current clinically significant disease. Health control meet any one of follow criteria should be excluded: 1. History of any diagnosis in Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria; 2. History of independent sleep disorder (e.g. obstructive sleep apnea, narcolepsy, bruxism, periodic limb movement disorder, restless legs syndrome and so on); 3. Current diseases which affect heart or respiratory, such as acute exacerbation of chronic obstructive pulmonary disease, acute exacerbation of asthma, sinus tachycardia, sinus bradycardia, arrhythmia and so on; 4. History of drug and alcohol dependence or acute intoxication; 5. Women in pregnancy or lactation; 6. Current clinically significant disease; 7. History of head trauma induced unconsciousness more than two minutes.;Exclusion criteria: Patients meet any one of follow criteria should be excluded: 1. History of manic episode hypomania episode; 2. History of bipolar, schizophrenia, schizoaffective disorder, or other psychotic disorders; 3. History of drug and alcohol dependence or acute intoxication; 4. Women in pregnancy or lactation; 5. Has specific anxiety symptoms, total score of HAMA>14; 6. Significant risk of suicidal behaviors, with severe suicidal risk in MINI, or HAMD-17 Item 3(suicide) score =3; 7. History of independent sleep disorder (e.g. obstructive sleep apnea, narcolepsy, bruxism, periodic limb movement disorder, restless legs syndrome and so on); 8. Organic brain diseases; 9. History of head trauma induced unconsciousness more than one hour; or obvious mental retardation; 10. Current diseases which affect heart or respiratory, such as acute exacerbation of chronic obstructive pulmonary disease, acute exacerbation of asthma, sinus tachycardia, sinus bradycardia, arrhythmia and so on; 11. Current clinically significant disease. Health control meet any one of follow criteria should be excluded: 1. History of any diagnosis in Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria; 2. History of independent sleep disorder (e.g. obstructive sleep apnea, narcolepsy, bruxism, periodic limb movement disorder, restless legs syndrome and so on); 3. Current diseases which affect heart or respiratory, such as acute exacerbation of chronic obstructive pulmonary disease, acute exacerbation of asthma, sinus tachycardia, sinus bradycardia, arrhythmia and so on; 4. History of drug and alcohol dependence or acute intoxication; 5. Women in pregnancy or lactation; 6. Current clinically significant disease; 7. History of head trauma induced unconsciousness more than two minutes.;Exclusion criteria: Patients meet any one of follow criteria should be excluded: 1. History of manic episode hypomania episode; 2. History of bipolar, schizophrenia, schizoaffective disorder, or other psychotic disorders; 3. History of drug and alcohol dependence or acute intoxication; 4. Women in pregnancy or lactation; 5. Has specific anxiety symptoms, total score of HAMA>14; 6. Significant risk of suicidal behaviors, with severe suicidal risk in MINI, or HAMD-17 Item 3(suicide) score =3; 7. History of independent sleep disorder (e.g. obstructive sleep apnea, narcolepsy, bruxism, periodic limb movement disorder, restless legs syndrome and so on); 8. Organic brain diseases; 9. History of head trauma induced unconsciousness more than one hour; or obvious mental retardation; 10. Current diseases which affect heart or respiratory, such as acute exacerbation of chronic obstructive pulmonary disease, acute exacerbation of asthma, sinus tachycardia, sinus bradycardia, arrhythmia and so on; 11. Current clinically significant disease. Health control meet any one of follow criteria should be excluded: 1. History of any diagnosis in Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria; 2. History of independent sleep disorder (e.g. obstructive sleep apnea, narcolepsy, bruxism, periodic limb movement disorder, restless legs syndrome and so on); 3. Current diseases which affect heart or respiratory, such as acute exacerbation of chronic obstructive pulmonary disease, acute exacerbation of asthma, sinus tachycardia, sinus bradycardia, arrhythmia and so on; 4. History of drug and alcohol dependence or acute intoxication; 5. Women in pregnancy or lactation; 6. Current clinically significant disease; 7. History of head trauma induced unconsciousness more than two minutes.

Design outcomes

Primary

MeasureTime frame
EEG parameters;ECG parameters;electrical skin activity parameters;pulse;blood oxygenation;body temperature;environmental temperature;electromyography (EMG);sleep parameters;

Countries

China

Contacts

Public ContactGang Wang;Gang Wang;Gang Wang;Gang Wang;Gang Wang ;;;;

Beijing Anding Hospital, Capital Medical University;Beijing Anding Hospital, Capital Medical University;Beijing Anding Hospital, Capital Medical University;Beijing Anding Hospital, Capital Medical University;Beijing Anding Hospital, Capital Medical University

gangwangdoc@vip.163.com;gangwangdoc@vip.163.com;gangwangdoc@vip.163.com;gangwangdoc@vip.163.com;gangwangdoc@vip.163.com+86 13911695727;+86 13911695727;+86 13911695727;+86 13911695727;+86 13911695727

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026