A Clinical Trial of Fluvoxamine for Melancholia

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.

Study Overview

• Status: Recruiting
• Conditions: Depressive Disorder; Melancholia; Endogenous Depression
• Intervention / Treatment: Drug: Fluvoxamine

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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xueqin Li; Phone Number: 0086-15015102836; Email: 876659651@qq.com

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410001
      • Recruiting
      • Mental Health Institute & Faculty of Psychiatry of The Second Xiangya Hospital, Central South University
      • Contact: Xueqin Li, MD; Phone Number: 0086-15015102836; Email: 876659651@qq.om

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: melancholic depression; patients with melancholic depression undergo the treatment of Fluvoxamine	Drug: Fluvoxamine; Fluvoxamine was assigned to be the treatment for the depression patients with melancholic features or not .; Other Names: Fluvoxamine Maleate Tablets
Experimental: non-melancholic depression; patients with non-melancholic depression undergo the treatment of Fluvoxamine	Drug: Fluvoxamine; Fluvoxamine was assigned to be the treatment for the depression patients with melancholic features or not .; Other Names: Fluvoxamine Maleate Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 2weeks, 1 months, 2 months
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.	Baseline, 1 months, 2 months
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.	Baseline, 2 months
Change in Functional connectivity	Change in Functional connectivity of the brain networks as assessed by measure of connectivity in multimodal MRI.	Baseline, 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in peripheral blood cytokines	Peripheral blood sample will be collected and the concentration of IL-6, TNF-α, and CRP will be assessed.	Baseline, 1 months, 2 months
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.	Baseline, 1 months, 2 months
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.	Baseline, 1 months, 2 months
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.	Baseline, 1 months, 2 months
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.	Baseline, 1 months, 2 months
Young Manic Rating Scale (YMSR)	The YMSR assesses the manic symptoms of the subjects.	Baseline, 1 months, 2 months
Life Event Scale (LES)	The LES assesses the effects of some life events on the subjects.	Baseline, 1 months, 2 months
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.	Baseline, 1 months, 2 months
Hopkins Vocabulary Learning Test-Revised (HVLT-R)	The HVLT-R assesses the memory and the cognition of the subjects.	Baseline, 1 months, 2 months
Sydney Melancholia Prototype Index (SMPI)	The SMPI aims to identify the melancholic and non-melancholic depression.	Baseline, 1 months, 2 months
Generalized Anxiety Disoder-7 (GAD-7)	The GAD-7 aims to assesses the severity of anxious symtoms.	Baseline, 1 months, 2 months
Self-reported Quick Inventory of Depressive Symptomatology (QIDS-SR) Scale	The QIDS-SR assesses the depressive symtoms in latest week of subjects quickly.	Baseline, 1 months, 2 months
Dimensional Anhedonia Rating Scale (DARS)	The DARS assesses different dimensions in Anhedonia of the subjects.	Baseline, 1 months, 2 months
Child Trauma Scale (CTQ)	The CTQ assesses child trauma happen to the subjects.	Baseline, 1 months, 2 months
Sheehan Disability Scale (SDS)	The SDS assesses the impairment in the occupational, familial and social ability of the subjects.	Baseline, 1 months, 2 months
Pittsburgh Sleep Quality Index (PSQI)	The PSQI assesses the sleep quality of the subjects.	Baseline, 1 months, 2 months
Perceived Deficit Questionnaire for Depression (PDQ-D)	The PDQ-D assesses the perceived deficit of the subjects	Baseline, 1 months, 2 months
Medication Adherence Rating Scale (MARS)	The MARS assesses the medication adherence condition of the subjects	1 months, 2 months
Rating Scale for Side Effects (SERS)	The SERS assesses the side effects of medication condition in the subjects	1 months, 2 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Halstead-Reitan neuropsychological test battery for adults（HRB）	Halstead-Reitan neuropsychological test battery for adults assesses the basic functions of the brain，including perception, orientation, attention, action speed and memory.	Baseline, 1 months, 2 months
Wechsler Scale (Digital Span)	Wechsler Scale (Digital Span) assesses the Attention and short-term memory of the subjects.	Baseline, 1 months, 2 months
Electroencephalogram (EEG)	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.	Baseline, 2 weeks

Collaborators and Investigators

• Sponsor: Lingjiang Li

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): September 30, 2022

Study Registration Dates

• First Submitted: November 8, 2019
• First Submitted That Met QC Criteria: November 8, 2019
• First Posted (Actual): November 13, 2019

Study Record Updates

• Last Update Posted (Actual): April 12, 2022
• Last Update Submitted That Met QC Criteria: April 7, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Enzyme Inhibitors; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Anti-Anxiety Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP1A2 Inhibitors; Cytochrome P-450 CYP2C19 Inhibitors; Fluvoxamine
• Other Study ID Numbers: 19-08-01-XY-0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No