Prospective Clinical Cohort Study of Depression

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: selective serotonin reuptake inhibitors; Device: TMS

Detailed Description

1. Research Treatment

   1.1 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 antidepressant treatment plan needed to be adjusted, one antidepressant should be selected as far as possible, and combined treatment with two or more antidepressants should not be allowed. Antipsychotics and mood stabilizers are not permitted. 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.

   1.2 Other treatment Settings

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

   1.3 Treatment compliance

   Participants were reminded to follow the medication regimen and their medication use was recorded at each visit. Non-use of prescription drugs for ≥70% of the time is considered noncompliance, and the reason for noncompliance should be checked. If there was a protocol violation, the protocol violation was recorded and the follow-up was continued as scheduled.

2. Observation index

Main observation indicators:

Clinical effect: Changes of clinical symptoms in acute phase, maintenance phase and long-term follow-up period. Changes in HAMD-17 scores at different follow-up points compared with baseline were used as the main efficacy evaluation index in this study. The evaluation criteria of clinical efficacy and significant endpoints at different stages are as follows:

① Early onset: The total score of HAMD-17 decreased by more than 20% from baseline after 2 weeks of treatment;

② Effective: The total score of HAMD-17 was reduced by more than 50% compared with baseline; Stable and effective was defined as two consecutive HAMD-17 scores decreased by more than 50% from baseline at the 8th weekend of the acute phase.

2.1 A method of measuring or evaluating observational indicators

1) General demographic data survey The patient's date of birth, gender, height, weight, nationality, marital status, occupation type and years of education were investigated.

Clinical information collection

2）Medical history information:

• Time of first onset of major depressive disorder/bipolar disorder
• The onset of the current depressive episode
• Total episodes (including this one) : depressive episodes

2.2 Scale evaluation(baseline, 2nd weekend±7days, 6th weekend±14days, 8th weekend±14days, 12th weekend±14days, Week 14-104 Every 4 weekends ± 14 days)：

We collect scale 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), and collect scale data of healthy controls during the baseline period.

self-rating scale： Snaith-Hamilton Pleasure Scale, SHAPS Generalized Anxiety Disorder,GAD-7 Patient Health Questionnare, PHQ-9 Hypomania Check List,HCL-33 Sheehan Disability Scale，SDS Childhood Trauma Questionnaire，CTQ Big 5 Personality Questionnaire， B5PQ Dysfunctional Attitude Scale，DAS Interpersonal Reactivity Index-C Scale for Suicide Ideation，SSI

Other rating scale Hamilton Depression Rating Scale for Depression - 17-item，HAMD-17 Hamilton Anxiety Scale，HAMA Brief Psychiatric Rating Scale, BPRS 4 items

2.3 EEG and eye movement data collection (baseline, 2nd weekend±7days, 6th weekend±14days, 8th weekend±14days, 12th weekend±14days, Week 14-104 Every 4 weekends ± 14 days)

We collect EEG and eye movement 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), and collect EEG and eye movement data of healthy controls during the baseline period.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310058
      • Sir Run Run Shaw Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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;
• Severe or unstable cardiovascular, respiratory, liver, kidney, endocrine, hematological or other conditions Other systemic diseases were not considered suitable for inclusion in this study.
• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.; Other Names: Psychotherapy and TMS; Device: TMS; TMS are allowed. The method, frequency, and duration of therapy should be recorded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sir Run Run Shaw Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): May 20, 2024

Study Registration Dates

• First Submitted: February 10, 2023
• First Submitted That Met QC Criteria: March 7, 2023
• First Posted (Actual): March 20, 2023

Study Record Updates

• Last Update Posted (Actual): October 27, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Serotonin Receptor Agonists; Serotonin; Selective Serotonin Reuptake Inhibitors
• Other Study ID Numbers: 2022-0334

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes