Back to resultsA Clinical Trial of Fluvoxamine for Melancholia
Primary Purpose
Depressive Disorder, Endogenous Depression, Melancholia
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Fluvoxamine
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Disorder
Eligibility Criteria
Inclusion Criteria:
- Adult (18-55 years, both sexes), with DSM-4 criteria for MDD without psychosis, as determined by a structured clinical interview Mini International Neuropsychiatric Interview
- Moderate to severe depression, as defined by a pretreatment score ≥17 on the HDRS-17 scale
- Informed consent to participate in this study
- ethinic Han, right-handed, Junior high school education or above
Exclusion Criteria:
- A history of bipolar disorder, schizophrenia, schizoaffective disorder, obsessive-compulsive disorder, panic disorder, or documented Axis II diagnoses; active suicidal intention, as determined by clinical interview
- Active or recent (<12 months) substance abuse or dependence; excluding nicotine
- Presence of ECT treatment in recent 6 months
- period of pregnancy or lactation
- hearing disorder or colour blindness
- Immediate relatives have bipolar disorder or mania disorder
Sites / Locations
- Mental Health Institute & Faculty of Psychiatry of The Second Xiangya Hospital, Central South UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
melancholic depression
non-melancholic depression
Arm Description
patients with melancholic depression undergo the treatment of Fluvoxamine
patients with non-melancholic depression undergo the treatment of Fluvoxamine
Outcomes
Primary Outcome Measures
Change in Hamilton Depression Rating Scale-17 item (HAMD-17)
Interview-based questionnaire used to measure the severity of depression. Consists of 17 items with a score calculated. Higher scores are associated with more severe depression.
Change in Hamilton Anxiety Rating Scale-14 item (HAMA-14)
Interview-based questionnaire used to measure the severity of anxiety. Consists of 14 items with a score calculated. Higher scores are associated with more severe anxiety.
Change in voxel-based morphometry of grey matter, white matter as assessed by structural magnetic resonancce imaging
Participants will receive resting-state functional magnetic resonance imaging (MRI). Scans will be performed on a 3.0- T Siemens Magnetom Skyra scanner (Siemens Healthineers, Erlangen, Germany). During scanning, all participants were instructed to remain motionless, and to think of nothing in particular but to not fall asleep.
Change in Functional connectivity
Change in Functional connectivity of the brain networks as assessed by measure of connectivity in multimodal MRI.
Secondary Outcome Measures
Change in peripheral blood cytokines
Peripheral blood sample will be collected and the concentration of IL-6, TNF-α, and CRP will be assessed.
Change in feces bacterial flora
The objective of investigator is to characterize gut microbiome in patients with TRD. To explore the specific diversity of gut microbiome. The stool samples were collected in the collection kits at the baseline, and were frozen at -80 °C. After the process of DNA Purification, 16S rRNA Gene Amplification and Illumina MiSeq sequencing, the study finally find the abundance and diversity of microbiota.
Change in Congruent STROOP Time to Complete (Executive Function)
Stroop Colour Naming Test (STROOP) is a cognitive test designed to assess the ability to inhibit a prepotent response to reading words while performing a task that requires attention control. It comprises two sheets with 50 words on each, and each word is the name of a colour. On the first sheet, the Congruent STROOP Sheet, the word and ink colour match; on the Incongruent STROOP Sheet, the word and ink colour do not match. For each sheet, the patient has 4 minutes to name the ink colour of each word. When the patient finishes the sheet, or once 4 minutes is up, the clinician notes the time taken and counts the number of correct and incorrect responses. The scale ranges from 0-100, the higher score the greater the cognitive flexibility.
Change in DSST (Number of Correct Symbols)
Digit Symbol Substitution Test (DSST) is a cognitive test designed to assess psychomotor speed of performance requiring visual perception, spatial decision-making, and motor skills. It consists of 133 digits and requires the patient to substitute each digit with a simple symbol in a 90-second period. Each correct symbol is counted, and the total score ranges from 0 (less than normal functioning) to 133 (greater than normal functioning)." as a description of DSST.
Improvement on Snaith-Hamilton Pleasure Scale (SHAPS)
The Snaith-Hamilton Pleasure Scale (SHAPS) assesses the anhedonia symptoms of MDD patients, with higher score indicating more severe anhedonia. Evaluating the patient's pleasure experience and choosing the degree of agreement with the happy response in some pleasant situations, and each item was rated on a 4-point scale."1 = Strongly agree, 2 = agree, 3 = disagree and 4
= strongly disagree" This scale evaluates the status of patients in the recent period of time, The total score of the scale is the sum of the scores of 14 items, with a total score of 14-56. The higher the total score, the more serious the anhedonia.
Young Manic Rating Scale (YMSR)
The YMSR assesses the manic symptoms of the subjects.
Life Event Scale (LES)
The LES assesses the effects of some life events on the subjects.
Beck Scale for Suicide Ideation（BSI）
The BSI assesses the Suicide Ideation of the subjects, including two time points, the latest week and when the subjects were the most depressive.
Hopkins Vocabulary Learning Test-Revised (HVLT-R)
The HVLT-R assesses the memory and the cognition of the subjects.
Sydney Melancholia Prototype Index (SMPI)
The SMPI aims to identify the melancholic and non-melancholic depression.
Generalized Anxiety Disoder-7 (GAD-7)
The GAD-7 aims to assesses the severity of anxious symtoms.
Self-reported Quick Inventory of Depressive Symptomatology (QIDS-SR) Scale
The QIDS-SR assesses the depressive symtoms in latest week of subjects quickly.
Dimensional Anhedonia Rating Scale (DARS)
The DARS assesses different dimensions in Anhedonia of the subjects.
Child Trauma Scale (CTQ)
The CTQ assesses child trauma happen to the subjects.
Sheehan Disability Scale (SDS)
The SDS assesses the impairment in the occupational, familial and social ability of the subjects.
Pittsburgh Sleep Quality Index (PSQI)
The PSQI assesses the sleep quality of the subjects.
Perceived Deficit Questionnaire for Depression (PDQ-D)
The PDQ-D assesses the perceived deficit of the subjects
Medication Adherence Rating Scale (MARS)
The MARS assesses the medication adherence condition of the subjects
Rating Scale for Side Effects (SERS)
The SERS assesses the side effects of medication condition in the subjects
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04160377
Brief Title
A Clinical Trial of Fluvoxamine for Melancholia
Official Title
A Clinical Trial of Fluvoxamine for Melancholia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lingjiang Li
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study aims at investigating the special effectiveness of antidepressant effect of Fluvoxamine for endogenous depression. The investigators also aim to assess the effect of Fluvoxamine on the multimodal magnetic resonance imaging(MRI), blood cytokines, feces bacteria flora and neuropsychological performance in depression patients with melancholic features. The investigators further aim to identify the predictors of Fluvoxamine's antidepressant effeect using the above techniques.
Detailed Description
This study aims at investigating the special effectiveness of antidepressant effect of Fluvoxamine for melancholia. The investigators also aim to assess the effect of Fluvoxamine on the multimodal magnetic resonance imaging(MRI), blood cytokines, feces bacteria flora and neuropsychological performance in depression patients with melancholic features. The investigators further aim to identify the predictors of Fluvoxamine's antidepressant effeect using the above techniques.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Endogenous Depression, Melancholia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
melancholic depression
Arm Type
Experimental
Arm Description
patients with melancholic depression undergo the treatment of Fluvoxamine
Arm Title
non-melancholic depression
Arm Type
Experimental
Arm Description
patients with non-melancholic depression undergo the treatment of Fluvoxamine
Intervention Type
Drug
Intervention Name(s)
Fluvoxamine
Other Intervention Name(s)
Fluvoxamine Maleate Tablets
Intervention Description
Fluvoxamine was assigned to be the treatment for the depression patients with melancholic features or not .
Primary Outcome Measure Information:
Title
Change in Hamilton Depression Rating Scale-17 item (HAMD-17)
Description
Interview-based questionnaire used to measure the severity of depression. Consists of 17 items with a score calculated. Higher scores are associated with more severe depression.
Time Frame
Baseline, 2weeks, 1 months, 2 months
Title
Change in Hamilton Anxiety Rating Scale-14 item (HAMA-14)
Description
Interview-based questionnaire used to measure the severity of anxiety. Consists of 14 items with a score calculated. Higher scores are associated with more severe anxiety.
Time Frame
Baseline, 1 months, 2 months
Title
Change in voxel-based morphometry of grey matter, white matter as assessed by structural magnetic resonancce imaging
Description
Participants will receive resting-state functional magnetic resonance imaging (MRI). Scans will be performed on a 3.0- T Siemens Magnetom Skyra scanner (Siemens Healthineers, Erlangen, Germany). During scanning, all participants were instructed to remain motionless, and to think of nothing in particular but to not fall asleep.
Time Frame
Baseline, 2 months
Title
Change in Functional connectivity
Description
Change in Functional connectivity of the brain networks as assessed by measure of connectivity in multimodal MRI.
Time Frame
Baseline, 2 months
Secondary Outcome Measure Information:
Title
Change in peripheral blood cytokines
Description
Peripheral blood sample will be collected and the concentration of IL-6, TNF-α, and CRP will be assessed.
Time Frame
Baseline, 1 months, 2 months
Title
Change in feces bacterial flora
Description
The objective of investigator is to characterize gut microbiome in patients with TRD. To explore the specific diversity of gut microbiome. The stool samples were collected in the collection kits at the baseline, and were frozen at -80 °C. After the process of DNA Purification, 16S rRNA Gene Amplification and Illumina MiSeq sequencing, the study finally find the abundance and diversity of microbiota.
Time Frame
Baseline, 1 months, 2 months
Title
Change in Congruent STROOP Time to Complete (Executive Function)
Description
Stroop Colour Naming Test (STROOP) is a cognitive test designed to assess the ability to inhibit a prepotent response to reading words while performing a task that requires attention control. It comprises two sheets with 50 words on each, and each word is the name of a colour. On the first sheet, the Congruent STROOP Sheet, the word and ink colour match; on the Incongruent STROOP Sheet, the word and ink colour do not match. For each sheet, the patient has 4 minutes to name the ink colour of each word. When the patient finishes the sheet, or once 4 minutes is up, the clinician notes the time taken and counts the number of correct and incorrect responses. The scale ranges from 0-100, the higher score the greater the cognitive flexibility.
Time Frame
Baseline, 1 months, 2 months
Title
Change in DSST (Number of Correct Symbols)
Description
Digit Symbol Substitution Test (DSST) is a cognitive test designed to assess psychomotor speed of performance requiring visual perception, spatial decision-making, and motor skills. It consists of 133 digits and requires the patient to substitute each digit with a simple symbol in a 90-second period. Each correct symbol is counted, and the total score ranges from 0 (less than normal functioning) to 133 (greater than normal functioning)." as a description of DSST.
Time Frame
Baseline, 1 months, 2 months
Title
Improvement on Snaith-Hamilton Pleasure Scale (SHAPS)
Description
The Snaith-Hamilton Pleasure Scale (SHAPS) assesses the anhedonia symptoms of MDD patients, with higher score indicating more severe anhedonia. Evaluating the patient's pleasure experience and choosing the degree of agreement with the happy response in some pleasant situations, and each item was rated on a 4-point scale."1 = Strongly agree, 2 = agree, 3 = disagree and 4
= strongly disagree" This scale evaluates the status of patients in the recent period of time, The total score of the scale is the sum of the scores of 14 items, with a total score of 14-56. The higher the total score, the more serious the anhedonia.
Time Frame
Baseline, 1 months, 2 months
Title
Young Manic Rating Scale (YMSR)
Description
The YMSR assesses the manic symptoms of the subjects.
Time Frame
Baseline, 1 months, 2 months
Title
Life Event Scale (LES)
Description
The LES assesses the effects of some life events on the subjects.
Time Frame
Baseline, 1 months, 2 months
Title
Beck Scale for Suicide Ideation（BSI）
Description
The BSI assesses the Suicide Ideation of the subjects, including two time points, the latest week and when the subjects were the most depressive.
Time Frame
Baseline, 1 months, 2 months
Title
Hopkins Vocabulary Learning Test-Revised (HVLT-R)
Description
The HVLT-R assesses the memory and the cognition of the subjects.
Time Frame
Baseline, 1 months, 2 months
Title
Sydney Melancholia Prototype Index (SMPI)
Description
The SMPI aims to identify the melancholic and non-melancholic depression.
Time Frame
Baseline, 1 months, 2 months
Title
Generalized Anxiety Disoder-7 (GAD-7)
Description
The GAD-7 aims to assesses the severity of anxious symtoms.
Time Frame
Baseline, 1 months, 2 months
Title
Self-reported Quick Inventory of Depressive Symptomatology (QIDS-SR) Scale
Description
The QIDS-SR assesses the depressive symtoms in latest week of subjects quickly.
Time Frame
Baseline, 1 months, 2 months
Title
Dimensional Anhedonia Rating Scale (DARS)
Description
The DARS assesses different dimensions in Anhedonia of the subjects.
Time Frame
Baseline, 1 months, 2 months
Title
Child Trauma Scale (CTQ)
Description
The CTQ assesses child trauma happen to the subjects.
Time Frame
Baseline, 1 months, 2 months
Title
Sheehan Disability Scale (SDS)
Description
The SDS assesses the impairment in the occupational, familial and social ability of the subjects.
Time Frame
Baseline, 1 months, 2 months
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
The PSQI assesses the sleep quality of the subjects.
Time Frame
Baseline, 1 months, 2 months
Title
Perceived Deficit Questionnaire for Depression (PDQ-D)
Description
The PDQ-D assesses the perceived deficit of the subjects
Time Frame
Baseline, 1 months, 2 months
Title
Medication Adherence Rating Scale (MARS)
Description
The MARS assesses the medication adherence condition of the subjects
Time Frame
1 months, 2 months
Title
Rating Scale for Side Effects (SERS)
Description
The SERS assesses the side effects of medication condition in the subjects
Time Frame
1 months, 2 months
Other Pre-specified Outcome Measures:
Title
Halstead-Reitan neuropsychological test battery for adults（HRB）
Description
Halstead-Reitan neuropsychological test battery for adults assesses the basic functions of the brain，including perception, orientation, attention, action speed and memory.
Time Frame
Baseline, 1 months, 2 months
Title
Wechsler Scale (Digital Span)
Description
Wechsler Scale (Digital Span) assesses the Attention and short-term memory of the subjects.
Time Frame
Baseline, 1 months, 2 months
Title
Electroencephalogram (EEG)
Description
EEG Microstate Parameters data like"ECG QT Interval" or "EEG power in the alpha band, etc., were collected at a 5000 Hz sampling rate, using a 64-channel Ag-Cl electrode (Brain Products) for both resting-state and task-state.
Time Frame
Baseline, 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adult (18-55 years, both sexes), with DSM-4 criteria for MDD without psychosis, as determined by a structured clinical interview Mini International Neuropsychiatric Interview
Moderate to severe depression, as defined by a pretreatment score ≥17 on the HDRS-17 scale
Informed consent to participate in this study
ethinic Han, right-handed, Junior high school education or above
Exclusion Criteria:
A history of bipolar disorder, schizophrenia, schizoaffective disorder, obsessive-compulsive disorder, panic disorder, or documented Axis II diagnoses; active suicidal intention, as determined by clinical interview
Active or recent (<12 months) substance abuse or dependence; excluding nicotine
Presence of ECT treatment in recent 6 months
period of pregnancy or lactation
hearing disorder or colour blindness
Immediate relatives have bipolar disorder or mania disorder
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xueqin Li
Phone
0086-15015102836
Email
876659651@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lingjiang Li, MD
Organizational Affiliation
Mental Health Institute, the Second Xiangya Hospital of Central South University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mental Health Institute & Faculty of Psychiatry of The Second Xiangya Hospital, Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xueqin Li, MD
Phone
0086-15015102836
Email
876659651@qq.om
12. IPD Sharing Statement
Plan to Share IPD
No
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A Clinical Trial of Fluvoxamine for Melancholia
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