Clinical trial NCT04160377: A Clinical Trial of Fluvoxamine for Melancholia
Official title: A Clinical Trial of Fluvoxamine for Melancholia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Depressive Disorder
Endogenous Depression
Melancholia
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2019-11-13
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Hamilton Depression Rating Scale-17 item (HAMD-17)
timeFrame: Baseline, 2weeks, 1 months, 2 months
measure: Change in Hamilton Anxiety Rating Scale-14 item (HAMA-14)
timeFrame: Baseline, 1 months, 2 months
measure: Change in voxel-based morphometry of grey matter, white matter as assessed by structural magnetic resonancce imaging
timeFrame: Baseline, 2 months
measure: Change in Functional connectivity
timeFrame: Baseline, 2 months
Secondary outcomes:
measure: Change in peripheral blood cytokines
timeFrame: Baseline, 1 months, 2 months
measure: Change in feces bacterial flora
timeFrame: Baseline, 1 months, 2 months
measure: Change in Congruent STROOP Time to Complete (Executive Function)
timeFrame: Baseline, 1 months, 2 months
measure: Change in DSST (Number of Correct Symbols)
timeFrame: Baseline, 1 months, 2 months
measure: Improvement on Snaith-Hamilton Pleasure Scale (SHAPS)
timeFrame: Baseline, 1 months, 2 months
measure: Young Manic Rating Scale (YMSR)
timeFrame: Baseline, 1 months, 2 months
measure: Life Event Scale (LES)
timeFrame: Baseline, 1 months, 2 months
measure: Beck Scale for Suicide Ideation（BSI）
timeFrame: Baseline, 1 months, 2 months
measure: Hopkins Vocabulary Learning Test-Revised (HVLT-R)
timeFrame: Baseline, 1 months, 2 months
measure: Sydney Melancholia Prototype Index (SMPI)
timeFrame: Baseline, 1 months, 2 months
measure: Generalized Anxiety Disoder-7 (GAD-7)
timeFrame: Baseline, 1 months, 2 months
measure: Self-reported Quick Inventory of Depressive Symptomatology (QIDS-SR) Scale
timeFrame: Baseline, 1 months, 2 months
measure: Dimensional Anhedonia Rating Scale (DARS)
timeFrame: Baseline, 1 months, 2 months
measure: Child Trauma Scale (CTQ)
timeFrame: Baseline, 1 months, 2 months
measure: Sheehan Disability Scale (SDS)
timeFrame: Baseline, 1 months, 2 months
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline, 1 months, 2 months
measure: Perceived Deficit Questionnaire for Depression (PDQ-D)
timeFrame: Baseline, 1 months, 2 months
measure: Medication Adherence Rating Scale (MARS)
timeFrame: 1 months, 2 months
measure: Rating Scale for Side Effects (SERS)
timeFrame: 1 months, 2 months
Other outcomes:
measure: Halstead-Reitan neuropsychological test battery for adults（HRB）
timeFrame: Baseline, 1 months, 2 months
measure: Wechsler Scale (Digital Span)
timeFrame: Baseline, 1 months, 2 months
measure: Electroencephalogram (EEG)
timeFrame: Baseline, 2 weeks
Locations:
city: Changsha
country: China
facility: Mental Health Institute & Faculty of Psychiatry of The Second Xiangya Hospital, Central South University
state: Hunan
Study officials:
affiliation: Mental Health Institute, the Second Xiangya Hospital of Central South University
name: Lingjiang Li, MD
role: PRINCIPAL_INVESTIGATOR
References: