Prospective Clinical Cohort Study of Depression

NCT05775809 | Unknown FDA Drug FDA Device

• 1 other identifier: 2022-0334
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective clinical cohort study of depression. The study was intended to include 300 patients with depression and 100 healthy controls. The study consisted of two phases: the baseline period and the follow-up period, in which all subjects were comprehensively collected, and the follow-up period in which all subjects were followed up at least once a year and data were collected. For patients with major depressive disorder, the follow-up methods included fixed visit and planned visit, and the follow-up time point covered the whole course of depressive disease(baseline, 2nd weekend±7days, 6th weekend±14days, 8th weekend±14days, 12th weekend±14days, Week 14-104 Every 4 weekends ± 14 days). Based on standardized, multi-strategy follow-up system and mobile health technology, long-term follow-up of patients with major depressive disorder was realized, and key nodes of patients' disease fluctuations were captured in time. High quality multidimensional data were collected, including demographic, clinical, EEG and eye movement data. Finally, the objective index system of depression was constructed, and the diagnosis, efficacy/recurrence prediction and suicide warning models of depression were established.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (94)

• score of Snaith-Hamilton Pleasure Scale, SHAPS

  rating scale

  baseline

• Generalized Anxiety Disorder,GAD-7

  rating scale

  baseline

• Patient Health Questionnare, PHQ-9

  rating scale

  baseline

• Hypomania Check List,HCL-33

  rating scale

  baseline

• Sheehan Disability Scale，SDS

  rating scale

  baseline

• Childhood Trauma Questionnaire，CTQ

  rating scale

  baseline

• Big 5 Personality Questionnaire， B5PQ

  rating scale

  baseline

• Dysfunctional Attitude Scale，DAS

  rating scale

  baseline

• Interpersonal Reactivity Index-C

  rating scale

  baseline

• Scale for Suicide Ideation，SSI

  rating scale

  baseline

• Hamilton Depression Rating Scale for Depression - 17-item，HAMD-17

  rating scale

  baseline

• Hamilton Anxiety Scale，HAMA

  rating scale

  baseline

• Brief Psychiatric Rating Scale, BPRS 4 items

  rating scale

  baseline

• score of Snaith-Hamilton Pleasure Scale, SHAPS

  rating scale

  2nd weekend±7days,

• score of Generalized Anxiety Disorder,GAD-7

  rating scale

  2nd weekend±7days,

• score of Patient Health Questionnare, PHQ-9

  rating scale

  2nd weekend±7days,

• score of Hypomania Check List,HCL-33

  rating scale

  2nd weekend±7days,

• score of Sheehan Disability Scale，SDS

  rating scale

  2nd weekend±7days,

• score of Interpersonal Reactivity Index-C

  rating scale

  2nd weekend±7days,

• score of Scale for Suicide Ideation，SSI

  rating scale

  2nd weekend±7days,

• Hamilton Depression Rating Scale for Depression - 17-item，HAMD-17

  rating scale

  2nd weekend±7days,

• Hamilton Anxiety Scale，HAMA

  rating scale

  2nd weekend±7days,

• score of Snaith-Hamilton Pleasure Scale, SHAPS

  rating scale

  6th weekend±14days,

• Generalized Anxiety Disorder,GAD-7

  rating scale

  6th weekend±14days,

• Patient Health Questionnare, PHQ-9

  rating scale

  6th weekend±14days,

• Hypomania Check List,HCL-33

  rating scale

  6th weekend±14days,

• Sheehan Disability Scale，SDS

  rating scale

  6th weekend±14days,

• Interpersonal Reactivity Index-C

  rating scale

  6th weekend±14days,

• Scale for Suicide Ideation，SSI

  rating scale

  6th weekend±14days,

• Hamilton Depression Rating Scale for Depression - 17-item，HAMD-17

  rating scale

  6th weekend±14days,

• Hamilton Anxiety Scale，HAMA

  rating scale

  6th weekend±14days,

• score of Snaith-Hamilton Pleasure Scale, SHAPS

  rating scale

  8th weekend±14days,

• score of Generalized Anxiety Disorder,GAD-7

  rating scale

  8th weekend±14days,

• score of Patient Health Questionnare, PHQ-9

  rating scale

  8th weekend±14days,

• score of Hypomania Check List,HCL-33

  rating scale

  8th weekend±14days,

• score of Sheehan Disability Scale，SDS

  rating scale

  8th weekend±14days,

• score of Interpersonal Reactivity Index-C

  rating scale

  8th weekend±14days,

• score of Scale for Suicide Ideation，SSI

  rating scale

  8th weekend±14days,

• score of Hamilton Depression Rating Scale for Depression - 17-item，HAMD-17

  rating scale

  8th weekend±14days,

• score of Hamilton Anxiety Scale，HAMA

  rating scale

  8th weekend±14days,

• score of Snaith-Hamilton Pleasure Scale, SHAPS

  rating scale

  12th weekend±14days,

• score of Generalized Anxiety Disorder,GAD-7

  rating scale

  12th weekend±14days,

• score of Patient Health Questionnare, PHQ-9

  rating scale

  12th weekend±14days,

• score of Hypomania Check List,HCL-33

  rating scale

  12th weekend±14days,

• score of Sheehan Disability Scale，SDS

  rating scale

  12th weekend±14days,

• score of Interpersonal Reactivity Index-C

  rating scale

  12th weekend±14days,

• score of Scale for Suicide Ideation，SSI

  rating scale

  12th weekend±14days,

• score of Hamilton Depression Rating Scale for Depression - 17-item，HAMD-17

  rating scale

  12th weekend±14days,

• score of Hamilton Anxiety Scale，HAMA

  rating scale

  12th weekend±14days,

• score of Snaith-Hamilton Pleasure Scale, SHAPS

  rating scale

  Week 14-104 Every 4 weekends ± 14 days

• Generalized Anxiety Disorder,GAD-7

  rating scale

  Week 14-104 Every 4 weekends ± 14 days

• score of Patient Health Questionnare, PHQ-9

  rating scale

  Week 14-104 Every 4 weekends ± 14 days

• score of Hypomania Check List,HCL-33

  rating scale

  Week 14-104 Every 4 weekends ± 14 days

• score of Sheehan Disability Scale，SDS

  rating scale

  Week 14-104 Every 4 weekends ± 14 days

• score of Interpersonal Reactivity Index-C

  rating scale

  Week 14-104 Every 4 weekends ± 14 days

• score of Scale for Suicide Ideation，SSI

  rating scale

  Week 14-104 Every 4 weekends ± 14 days

• score of Hamilton Depression Rating Scale for Depression - 17-item，HAMD-17

  rating scale

  Week 14-104 Every 4 weekends ± 14 days

• score of Hamilton Anxiety Scale，HAMA

  rating scale

  Week 14-104 Every 4 weekends ± 14 days

• average power of 4 bands: δ (1-4 Hz)、 θ (4-8 Hz)、 α (8-13 Hz)、 β (13-30 Hz)

  EEG features

  baseline

• 1.Average duration of EEG microstates 2. The average number of occurrences of EEG microstates per second 3. Average percentage of time covered by EEG microstates 4.the calculation of microstate transition.

  EEG features

  baseline

• Connectivity index of full-band brain function network, and connectivity index of each band brain function network

  EEG features

  baseline

• EEG features extracted by machine learning

  EEG features

  baseline

• average power of 4 bands: δ (1-4 Hz)、 θ (4-8 Hz)、 α (8-13 Hz)、 β (13-30 Hz)

  EEG features

  2nd weekend±7days

• Average duration of EEG microstates 2. The average number of occurrences of EEG microstates per second 3. Average percentage of time covered by EEG microstates 4.the calculation of microstate transition.

  EEG features

  2nd weekend±7days

• Connectivity index of full-band brain function network, and connectivity index of each band brain function network

  EEG features

  2nd weekend±7days

• EEG features extracted by machine learning

  EEG features

  2nd weekend±7days

• average power of 4 bands: δ (1-4 Hz)、 θ (4-8 Hz)、 α (8-13 Hz)、 β (13-30 Hz)

  EEG features

  6th weekend±14days

• 1.Average duration of EEG microstates 2. The average number of occurrences of EEG microstates per second 3. Average percentage of time covered by EEG microstates 4.the calculation of microstate transition.

  EEG features

  6th weekend±14days

• Connectivity index of full-band brain function network, and connectivity index of each band brain function network

  EEG features

  6th weekend±14days

• EEG features extracted by machine learning

  EEG features

  6th weekend±14days

• average power of 4 bands: δ (1-4 Hz)、 θ (4-8 Hz)、 α (8-13 Hz)、 β (13-30 Hz)

  EEG features

  8th weekend±14days

• 1.Average duration of EEG microstates 2. The average number of occurrences of EEG microstates per second 3. Average percentage of time covered by EEG microstates 4.the calculation of microstate transition.

  EEG features

  8th weekend±14days

• Connectivity index of full-band brain function network, and connectivity index of each band brain function network

  EEG features

  8th weekend±14days

• EEG features extracted by machine learning

  EEG features

  8th weekend±14days

• average power of 4 bands: δ (1-4 Hz)、 θ (4-8 Hz)、 α (8-13 Hz)、 β (13-30 Hz)

  EEG features

  12th weekend±14days

• 1.Average duration of EEG microstates 2. The average number of occurrences of EEG microstates per second 3. Average percentage of time covered by EEG microstates 4.the calculation of microstate transition.

  EEG features

  12th weekend±14days

• Connectivity index of full-band brain function network, and connectivity index of each band brain function network

  EEG features

  12th weekend±14days

• EEG features extracted by machine learning

  EEG features

  12th weekend±14days

• average power of 4 bands: δ (1-4 Hz)、 θ (4-8 Hz)、 α (8-13 Hz)、 β (13-30 Hz)

  EEG features

  Week 14-104 Every 4 weekends ± 14 days

• 1.Average duration of EEG microstates 2. The average number of occurrences of EEG microstates per second 3. Average percentage of time covered by EEG microstates 4.the calculation of microstate transition.

  EEG features

  Week 14-104 Every 4 weekends ± 14 days

• Connectivity index of full-band brain function network, and connectivity index of each band brain function network

  EEG features

  Week 14-104 Every 4 weekends ± 14 days

• EEG features extracted by machine learning

  EEG features

  Week 14-104 Every 4 weekends ± 14 days

• Eye movement index

  Collect resting eye movement data and task eye movement data. For eye movement data, features are extracted from blinking, scanning, staring, pupil diameter, initial fixation latency, initial fixation duration, total fixation duration and area of interest and so on.

  baseline

• Eye movement index

  Collect resting eye movement data and task eye movement data. For eye movement data, features are extracted from blinking, scanning, staring, pupil diameter, initial fixation latency, initial fixation duration, total fixation duration and area of interest and so on.

  2nd weekend±7days

• Eye movement index

  Collect resting eye movement data and task eye movement data. For eye movement data, features are extracted from blinking, scanning, staring, pupil diameter, initial fixation latency, initial fixation duration, total fixation duration and area of interest and so on.

  6th weekend±14days

• Eye movement index

  Collect resting eye movement data and task eye movement data. For eye movement data, features are extracted from blinking, scanning, staring, pupil diameter, initial fixation latency, initial fixation duration, total fixation duration and area of interest and so on.

  8th weekend±14days

• Eye movement index

  Collect resting eye movement data and task eye movement data. For eye movement data, features are extracted from blinking, scanning, staring, pupil diameter, initial fixation latency, initial fixation duration, total fixation duration and area of interest and so on.

  12th weekend±14days

• Eye movement index

  Collect resting eye movement data and task eye movement data. For eye movement data, features are extracted from blinking, scanning, staring, pupil diameter, initial fixation latency, initial fixation duration, total fixation duration and area of interest and so on.

  Week 14-104 Every 4 weekends ± 14 days

• Eye movement features extracted by machine learning

  Eye movement features extracted by machine learning

  baseline

• Eye movement features extracted by machine learning

  Eye movement features extracted by machine learning

  2nd weekend±7days

• Eye movement features extracted by machine learning

  Eye movement features extracted by machine learning

  6th weekend±14days

• Eye movement features extracted by machine learning

  Eye movement features extracted by machine learning

  8th weekend±14days

• Eye movement features extracted by machine learning

  Eye movement features extracted by machine learning

  12th weekend±14days

• Eye movement features extracted by machine learning

  Eye movement features extracted by machine learning

  Week 14-104 Every 4 weekends ± 14 days

Study Arms (1)

Patients with major depressive disorder

We collect data of patients with major depressive disorder at different point (baseline, 2nd weekend±7days, 6th weekend±14days, 8th weekend±14days, 12th weekend±14days, Week 14-104 Every 4 weekends ± 14 days).

Drug: selective serotonin reuptake inhibitors; Device: TMS

Interventions

selective serotonin reuptake inhibitors DRUG

Research Treatment Drug treatment The patient did not take antidepressant treatment at least 14 days before enrollment (the patients treated with fluoxetine before enrollment should stop using it for at least 28 days). During 8 weeks, all subjects with major depressive disorder received effective dosages of selective serotonin reuptake inhibitors, and all subjects with major depressive disorder were limited to a single class of antidepressants. If the treatment of selective serotonin reuptake inhibitors is not effective after eight weeks, the drugs can be considered for replacement. The drugs for replacement include but are not limited to selective serotonin reuptake inhibitors. Other treatment Settings Psychotherapy and TMS are allowed. The method, frequency, and duration of therapy should be recorded.

Also known as: Psychotherapy and TMS

Patients with major depressive disorder

TMS DEVICE

TMS are allowed. The method, frequency, and duration of therapy should be recorded.

Patients with major depressive disorder

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Depression is a mental state characterized by persistent low mood, loss of interest and pleasure in daily activities, autonomic disorders and decreased energy, resulting in varying degrees of impairment of social and occupational functioning.

You may qualify if:

• Out-patient or in-patient aged 18-65 years (including 18 and 65 years), regardless of gender;
• The Chinese version of the Concise International Neuropsychiatric Interview (M.I.N.I.) 7.0.2 type interview, in line with the DSM-5 Diagnostic criteria for major depressive disorder, either first or recurrent;
• Screening and baseline Hamilton Depression Scale (HAMD-17) Score ≥14;
• No antidepressants were taken for at least 14 days prior to enrollment (patients treated with fluoxetine prior to enrollment should Stop for at least 28 days);
• A single class of antidepressant medication is planned;
• Primary school education or above, able to understand the research content;
• Understand and voluntarily participate in this study, and I sign the informed consent.

You may not qualify if:

• A current or previous DSM-5 diagnosis of a major mental disorder other than major depressive disorder, Such as neurodevelopmental disorders, neurocognitive disorders, schizophrenia and other psychotic disorders, bipolar disorder Sensory disorder, obsessive disorder, panic disorder, post-traumatic stress disorder, alcohol (or drug) dependence or abuse User and personality disorder;
• depression secondary to an organic mental disorder caused by a systemic disease or a neurological disease Seizures, such as depression caused by hypothyroidism;
• During the screening period or baseline period, the investigators considered that the physical examination and laboratory examination of the patients were abnormal and judged to have significant clinical significance Bedsense;
• had received systemic Modified Electric therapy (Modified Electric) 3 months before screening Convulsive Therapy, MECT) or Transcranial Magnetic stimulation (Transcranial Magnetic Stimulation (TMS), Deep Brain Stimulation (DBS), Vagus Nerve Stimulation (VNS);
• The withdrawal of psychotropic drugs did not reach 7 half-lives before screening.

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead

Study Sites (1)

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, 310058, China

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Selective Serotonin Reuptake Inhibitors; Psychotherapy

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs; Behavioral Disciplines and Activities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Major Investigators

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: March 20, 2023
• Study Start: June 15, 2023
• Primary Completion: December 1, 2023
• Study Completion: May 20, 2024
• Last Updated: October 27, 2023

Record last verified: 2023-10

Locations

CN (1)