Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05775809
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-10-27
First Post:
2023-02-10
Brief Title:
Prospective Clinical Cohort Study of Depression
Sponsor:
Sir Run Run Shaw Hospital
Organization:
Sir Run Run Shaw Hospital
Study Overview
Official Title:
Prospective Clinical Cohort Study of Depression
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 diseasebaseline 2nd weekend7days 6th weekend14days 8th weekend14days 12th weekend14days 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 efficacyrecurrence prediction and suicide warning models of depression were established
Detailed Description:
1 Research Treatment
11 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
12 Other treatment Settings
Psychotherapy and TMS are allowed The method frequency and duration of therapy should be recorded
13 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
21 A method of measuring or evaluating observational indicators
1 General demographic data survey The patients date of birth gender height weight nationality marital status occupation type and years of education were investigated
Clinical information collection
2Medical history information
Time of first onset of major depressive disorderbipolar disorder
The onset of the current depressive episode
Total episodes including this one depressive episodes
22 Scale evaluationbaseline 2nd weekend7days 6th weekend14days 8th weekend14days 12th weekend14days Week 14-104 Every 4 weekends 14 days
We collect scale data of patients with major depressive disorder at different point baseline 2nd weekend7days 6th weekend14days 8th weekend14days 12th weekend14days 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 DisorderGAD-7 Patient Health Questionnare PHQ-9 Hypomania Check ListHCL-33 Sheehan Disability ScaleSDS Childhood Trauma QuestionnaireCTQ Big 5 Personality Questionnaire B5PQ Dysfunctional Attitude ScaleDAS Interpersonal Reactivity Index-C Scale for Suicide IdeationSSI
Other rating scale Hamilton Depression Rating Scale for Depression - 17-itemHAMD-17 Hamilton Anxiety ScaleHAMA Brief Psychiatric Rating Scale BPRS 4 items
23 EEG and eye movement data collection baseline 2nd weekend7days 6th weekend14days 8th weekend14days 12th weekend14days Week 14-104 Every 4 weekends 14 days
We collect EEG and eye movement data of patients with major depressive disorder at different pointbaseline 2nd weekend7days 6th weekend14days 8th weekend14days 12th weekend14days Week 14-104 Every 4 weekends 14 days and collect EEG and eye movement data of healthy controls during the baseline period
11 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
12 Other treatment Settings
Psychotherapy and TMS are allowed The method frequency and duration of therapy should be recorded
13 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
21 A method of measuring or evaluating observational indicators
1 General demographic data survey The patients date of birth gender height weight nationality marital status occupation type and years of education were investigated
Clinical information collection
2Medical history information
Time of first onset of major depressive disorderbipolar disorder
The onset of the current depressive episode
Total episodes including this one depressive episodes
22 Scale evaluationbaseline 2nd weekend7days 6th weekend14days 8th weekend14days 12th weekend14days Week 14-104 Every 4 weekends 14 days
We collect scale data of patients with major depressive disorder at different point baseline 2nd weekend7days 6th weekend14days 8th weekend14days 12th weekend14days 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 DisorderGAD-7 Patient Health Questionnare PHQ-9 Hypomania Check ListHCL-33 Sheehan Disability ScaleSDS Childhood Trauma QuestionnaireCTQ Big 5 Personality Questionnaire B5PQ Dysfunctional Attitude ScaleDAS Interpersonal Reactivity Index-C Scale for Suicide IdeationSSI
Other rating scale Hamilton Depression Rating Scale for Depression - 17-itemHAMD-17 Hamilton Anxiety ScaleHAMA Brief Psychiatric Rating Scale BPRS 4 items
23 EEG and eye movement data collection baseline 2nd weekend7days 6th weekend14days 8th weekend14days 12th weekend14days Week 14-104 Every 4 weekends 14 days
We collect EEG and eye movement data of patients with major depressive disorder at different pointbaseline 2nd weekend7days 6th weekend14days 8th weekend14days 12th weekend14days Week 14-104 Every 4 weekends 14 days and collect EEG and eye movement data of healthy controls during the baseline period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None