A Clinical Trial of Fluvoxamine for Melancholia

NCT04160377 | Unknown Phase 2

• 1 other identifier: 19-08-01-XY-0001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Disorder; Endogenous Depression; Melancholia

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (19)

• Change in peripheral blood cytokines

  Baseline, 1 months, 2 months

• Change in feces bacterial flora

  Baseline, 1 months, 2 months

• Change in Congruent STROOP Time to Complete (Executive Function)

  Baseline, 1 months, 2 months

• Change in DSST (Number of Correct Symbols)

  Baseline, 1 months, 2 months

• Improvement on Snaith-Hamilton Pleasure Scale (SHAPS)

  Baseline, 1 months, 2 months

Other Outcomes (3)

• Halstead-Reitan neuropsychological test battery for adults（HRB）

  Baseline, 1 months, 2 months

• Wechsler Scale (Digital Span)

  Baseline, 1 months, 2 months

• Electroencephalogram (EEG)

  Baseline, 2 weeks

Study Arms (2)

melancholic depression

EXPERIMENTAL

patients with melancholic depression undergo the treatment of Fluvoxamine

Drug: Fluvoxamine

non-melancholic depression

EXPERIMENTAL

patients with non-melancholic depression undergo the treatment of Fluvoxamine

Drug: Fluvoxamine

Interventions

Fluvoxamine DRUG

Fluvoxamine was assigned to be the treatment for the depression patients with melancholic features or not .

Also known as: Fluvoxamine Maleate Tablets

melancholic depression; non-melancholic depression

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lingjiang Li: lead

Study Sites (1)

Mental Health Institute & Faculty of Psychiatry of The Second Xiangya Hospital, Central South University

Changsha, Hunan, 410001, China

RECRUITING

Related Publications (1)

• Li X, Yan D, Liao M, Zhang L, Li Z, Liu B, Chen Y, Zhang Y, Liu J, Li L. Effect of fluvoxamine on plasma interleukin-6 in patients with major depressive disorder: a prospective follow-up study. Front Psychiatry. 2023 May 25;14:1163754. doi: 10.3389/fpsyt.2023.1163754. eCollection 2023.

  PMID: 37304432 DERIVED

MeSH Terms

Conditions

Depressive Disorder

Interventions

Fluvoxamine

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Oximes; Hydroxylamines; Amines; Organic Chemicals

Study Officials

• Lingjiang Li, MD

  Mental Health Institute, the Second Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xueqin Li

CONTACT

0086-15015102836; 876659651@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: President of Chinese Psychiatry Society of Chinese Medical

Study Record Dates

• First Submitted: November 8, 2019
• First Posted: November 13, 2019
• Study Start: August 1, 2019
• Primary Completion: June 30, 2022
• Study Completion: September 30, 2022
• Last Updated: April 12, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)