Prospective Clinical Cohort Study of Depression

Major Depressive Disorder Clinical Trial

Official title:

Prospective Clinical Cohort Study of Depression

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05775809
• Other study ID #: 2022-0334
• Status: Enrolling by invitation
• Start date: June 15, 2023
• Est. completion date: May 20, 2024

Study information

• Verified date: October 2023
• Source: Sir Run Run Shaw Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: May 20, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

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.

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

Locations

Country	Name	City	State
China	Sir Run Run Shaw Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Sir Run Run Shaw Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	score of Snaith-Hamilton Pleasure Scale, SHAPS	rating scale	baseline
Primary	Generalized Anxiety Disorder,GAD-7	rating scale	baseline
Primary	Patient Health Questionnare, PHQ-9	rating scale	baseline
Primary	Hypomania Check List,HCL-33	rating scale	baseline
Primary	Sheehan Disability Scale,SDS	rating scale	baseline
Primary	Childhood Trauma Questionnaire,CTQ	rating scale	baseline
Primary	Big 5 Personality Questionnaire, B5PQ	rating scale	baseline
Primary	Dysfunctional Attitude Scale,DAS	rating scale	baseline
Primary	Interpersonal Reactivity Index-C	rating scale	baseline
Primary	Scale for Suicide Ideation,SSI	rating scale	baseline
Primary	Hamilton Depression Rating Scale for Depression - 17-item,HAMD-17	rating scale	baseline
Primary	Hamilton Anxiety Scale,HAMA	rating scale	baseline
Primary	Brief Psychiatric Rating Scale, BPRS 4 items	rating scale	baseline
Primary	score of Snaith-Hamilton Pleasure Scale, SHAPS	rating scale	2nd weekend±7days,
Primary	score of Generalized Anxiety Disorder,GAD-7	rating scale	2nd weekend±7days,
Primary	score of Patient Health Questionnare, PHQ-9	rating scale	2nd weekend±7days,
Primary	score of Hypomania Check List,HCL-33	rating scale	2nd weekend±7days,
Primary	score of Sheehan Disability Scale,SDS	rating scale	2nd weekend±7days,
Primary	score of Interpersonal Reactivity Index-C	rating scale	2nd weekend±7days,
Primary	score of Scale for Suicide Ideation,SSI	rating scale	2nd weekend±7days,
Primary	Hamilton Depression Rating Scale for Depression - 17-item,HAMD-17	rating scale	2nd weekend±7days,
Primary	Hamilton Anxiety Scale,HAMA	rating scale	2nd weekend±7days,
Primary	score of Snaith-Hamilton Pleasure Scale, SHAPS	rating scale	6th weekend±14days,
Primary	Generalized Anxiety Disorder,GAD-7	rating scale	6th weekend±14days,
Primary	Patient Health Questionnare, PHQ-9	rating scale	6th weekend±14days,
Primary	Hypomania Check List,HCL-33	rating scale	6th weekend±14days,
Primary	Sheehan Disability Scale,SDS	rating scale	6th weekend±14days,
Primary	Interpersonal Reactivity Index-C	rating scale	6th weekend±14days,
Primary	Scale for Suicide Ideation,SSI	rating scale	6th weekend±14days,
Primary	Hamilton Depression Rating Scale for Depression - 17-item,HAMD-17	rating scale	6th weekend±14days,
Primary	Hamilton Anxiety Scale,HAMA	rating scale	6th weekend±14days,
Primary	score of Snaith-Hamilton Pleasure Scale, SHAPS	rating scale	8th weekend±14days,
Primary	score of Generalized Anxiety Disorder,GAD-7	rating scale	8th weekend±14days,
Primary	score of Patient Health Questionnare, PHQ-9	rating scale	8th weekend±14days,
Primary	score of Hypomania Check List,HCL-33	rating scale	8th weekend±14days,
Primary	score of Sheehan Disability Scale,SDS	rating scale	8th weekend±14days,
Primary	score of Interpersonal Reactivity Index-C	rating scale	8th weekend±14days,
Primary	score of Scale for Suicide Ideation,SSI	rating scale	8th weekend±14days,
Primary	score of Hamilton Depression Rating Scale for Depression - 17-item,HAMD-17	rating scale	8th weekend±14days,
Primary	score of Hamilton Anxiety Scale,HAMA	rating scale	8th weekend±14days,
Primary	score of Snaith-Hamilton Pleasure Scale, SHAPS	rating scale	12th weekend±14days,
Primary	score of Generalized Anxiety Disorder,GAD-7	rating scale	12th weekend±14days,
Primary	score of Patient Health Questionnare, PHQ-9	rating scale	12th weekend±14days,
Primary	score of Hypomania Check List,HCL-33	rating scale	12th weekend±14days,
Primary	score of Sheehan Disability Scale,SDS	rating scale	12th weekend±14days,
Primary	score of Interpersonal Reactivity Index-C	rating scale	12th weekend±14days,
Primary	score of Scale for Suicide Ideation,SSI	rating scale	12th weekend±14days,
Primary	score of Hamilton Depression Rating Scale for Depression - 17-item,HAMD-17	rating scale	12th weekend±14days,
Primary	score of Hamilton Anxiety Scale,HAMA	rating scale	12th weekend±14days,
Primary	score of Snaith-Hamilton Pleasure Scale, SHAPS	rating scale	Week 14-104 Every 4 weekends ± 14 days
Primary	Generalized Anxiety Disorder,GAD-7	rating scale	Week 14-104 Every 4 weekends ± 14 days
Primary	score of Patient Health Questionnare, PHQ-9	rating scale	Week 14-104 Every 4 weekends ± 14 days
Primary	score of Hypomania Check List,HCL-33	rating scale	Week 14-104 Every 4 weekends ± 14 days
Primary	score of Sheehan Disability Scale,SDS	rating scale	Week 14-104 Every 4 weekends ± 14 days
Primary	score of Interpersonal Reactivity Index-C	rating scale	Week 14-104 Every 4 weekends ± 14 days
Primary	score of Scale for Suicide Ideation,SSI	rating scale	Week 14-104 Every 4 weekends ± 14 days
Primary	score of Hamilton Depression Rating Scale for Depression - 17-item,HAMD-17	rating scale	Week 14-104 Every 4 weekends ± 14 days
Primary	score of Hamilton Anxiety Scale,HAMA	rating scale	Week 14-104 Every 4 weekends ± 14 days
Primary	average power of 4 bands: d (1-4 Hz)? ? (4-8 Hz)? a (8-13 Hz)? ß (13-30 Hz)	EEG features	baseline
Primary	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
Primary	Connectivity index of full-band brain function network, and connectivity index of each band brain function network	EEG features	baseline
Primary	EEG features extracted by machine learning	EEG features	baseline
Primary	average power of 4 bands: d (1-4 Hz)? ? (4-8 Hz)? a (8-13 Hz)? ß (13-30 Hz)	EEG features	2nd weekend±7days
Primary	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
Primary	Connectivity index of full-band brain function network, and connectivity index of each band brain function network	EEG features	2nd weekend±7days
Primary	EEG features extracted by machine learning	EEG features	2nd weekend±7days
Primary	average power of 4 bands: d (1-4 Hz)? ? (4-8 Hz)? a (8-13 Hz)? ß (13-30 Hz)	EEG features	6th weekend±14days
Primary	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
Primary	Connectivity index of full-band brain function network, and connectivity index of each band brain function network	EEG features	6th weekend±14days
Primary	EEG features extracted by machine learning	EEG features	6th weekend±14days
Primary	average power of 4 bands: d (1-4 Hz)? ? (4-8 Hz)? a (8-13 Hz)? ß (13-30 Hz)	EEG features	8th weekend±14days
Primary	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
Primary	Connectivity index of full-band brain function network, and connectivity index of each band brain function network	EEG features	8th weekend±14days
Primary	EEG features extracted by machine learning	EEG features	8th weekend±14days
Primary	average power of 4 bands: d (1-4 Hz)? ? (4-8 Hz)? a (8-13 Hz)? ß (13-30 Hz)	EEG features	12th weekend±14days
Primary	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
Primary	Connectivity index of full-band brain function network, and connectivity index of each band brain function network	EEG features	12th weekend±14days
Primary	EEG features extracted by machine learning	EEG features	12th weekend±14days
Primary	average power of 4 bands: d (1-4 Hz)? ? (4-8 Hz)? a (8-13 Hz)? ß (13-30 Hz)	EEG features	Week 14-104 Every 4 weekends ± 14 days
Primary	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
Primary	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
Primary	EEG features extracted by machine learning	EEG features	Week 14-104 Every 4 weekends ± 14 days
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Eye movement features extracted by machine learning	Eye movement features extracted by machine learning	baseline
Primary	Eye movement features extracted by machine learning	Eye movement features extracted by machine learning	2nd weekend±7days
Primary	Eye movement features extracted by machine learning	Eye movement features extracted by machine learning	6th weekend±14days
Primary	Eye movement features extracted by machine learning	Eye movement features extracted by machine learning	8th weekend±14days
Primary	Eye movement features extracted by machine learning	Eye movement features extracted by machine learning	12th weekend±14days
Primary	Eye movement features extracted by machine learning	Eye movement features extracted by machine learning	Week 14-104 Every 4 weekends ± 14 days