A Clinical Trial of Fluvoxamine for Melancholia
- Registration Number
- NCT04160377
- Lead Sponsor
- Lingjiang Li
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 150
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description melancholic depression Fluvoxamine patients with melancholic depression undergo the treatment of Fluvoxamine non-melancholic depression Fluvoxamine patients with non-melancholic depression undergo the treatment of Fluvoxamine
- Primary Outcome Measures
Name Time Method Change in Hamilton Depression Rating Scale-17 item (HAMD-17) Baseline, 2weeks, 1 months, 2 months 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 voxel-based morphometry of grey matter, white matter as assessed by structural magnetic resonancce imaging Baseline, 2 months 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 Baseline, 2 months Change in Functional connectivity of the brain networks as assessed by measure of connectivity in multimodal MRI.
Change in Hamilton Anxiety Rating Scale-14 item (HAMA-14) Baseline, 1 months, 2 months 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.
- Secondary Outcome Measures
Name Time Method Change in peripheral blood cytokines Baseline, 1 months, 2 months Peripheral blood sample will be collected and the concentration of IL-6, TNF-α, and CRP will be assessed.
Change in feces bacterial flora Baseline, 1 months, 2 months 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.
Hopkins Vocabulary Learning Test-Revised (HVLT-R) Baseline, 1 months, 2 months The HVLT-R assesses the memory and the cognition of the subjects.
Generalized Anxiety Disoder-7 (GAD-7) Baseline, 1 months, 2 months The GAD-7 aims to assesses the severity of anxious symtoms.
Sheehan Disability Scale (SDS) Baseline, 1 months, 2 months The SDS assesses the impairment in the occupational, familial and social ability of the subjects.
Pittsburgh Sleep Quality Index (PSQI) Baseline, 1 months, 2 months The PSQI assesses the sleep quality of the subjects.
Change in Congruent STROOP Time to Complete (Executive Function) Baseline, 1 months, 2 months 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) Baseline, 1 months, 2 months 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) Baseline, 1 months, 2 months 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.Life Event Scale (LES) Baseline, 1 months, 2 months The LES assesses the effects of some life events on the subjects.
Sydney Melancholia Prototype Index (SMPI) Baseline, 1 months, 2 months The SMPI aims to identify the melancholic and non-melancholic depression.
Self-reported Quick Inventory of Depressive Symptomatology (QIDS-SR) Scale Baseline, 1 months, 2 months The QIDS-SR assesses the depressive symtoms in latest week of subjects quickly.
Perceived Deficit Questionnaire for Depression (PDQ-D) Baseline, 1 months, 2 months The PDQ-D assesses the perceived deficit of the subjects
Young Manic Rating Scale (YMSR) Baseline, 1 months, 2 months The YMSR assesses the manic symptoms of the subjects.
Dimensional Anhedonia Rating Scale (DARS) Baseline, 1 months, 2 months The DARS assesses different dimensions in Anhedonia of the subjects.
Child Trauma Scale (CTQ) Baseline, 1 months, 2 months The CTQ assesses child trauma happen to the subjects.
Rating Scale for Side Effects (SERS) 1 months, 2 months The SERS assesses the side effects of medication condition in the subjects
Beck Scale for Suicide Ideation（BSI） Baseline, 1 months, 2 months The BSI assesses the Suicide Ideation of the subjects, including two time points, the latest week and when the subjects were the most depressive.
Medication Adherence Rating Scale (MARS) 1 months, 2 months The MARS assesses the medication adherence condition of the subjects
Trial Locations
- Locations (1)
Mental Health Institute & Faculty of Psychiatry of The Second Xiangya Hospital, Central South University
🇨🇳Changsha, Hunan, China