Depressive DisorderPhase 2NCT04160377
A Clinical Trial of Fluvoxamine for Melancholia
A Phase 2 study testing Fluvoxamine in people with Depressive Disorder and Endogenous Depression, run by Lingjiang Li at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Depressive Disorder, Endogenous Depression, Melancholia
- What is being tested?
- Fluvoxamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2019to 30 Sep 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Mental Health Institute & Faculty of Psychiatry of The Second Xiangya Hospital, Central South University
Changsha, Hunan, 410001
Xueqin Li, MD, 0086-15015102836, 876659651@qq.om
About this study
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.
Read the 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.
- Conditions
- Depressive Disorder, Endogenous Depression, Melancholia
- Being tested
- Fluvoxamine
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluvoxamineDrug
Also called Fluvoxamine Maleate Tablets
Fluvoxamine was assigned to be the treatment for the depression patients with melancholic features or not .
| Study group | Role | What they receive |
|---|---|---|
| melancholic depression | Experimental | patients with melancholic depression undergo the treatment of Fluvoxamine Receives: Drug: Fluvoxamine |
| non-melancholic depression | Experimental | patients with non-melancholic depression undergo the treatment of Fluvoxamine Receives: Drug: Fluvoxamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, 2 months
Change in Functional connectivity
Change in Functional connectivity of the brain networks as assessed by measure of connectivity in multimodal MRI.
Measured: Baseline, 2 months
Secondary outcomes (19)
Change in peripheral blood cytokines
Peripheral blood sample will be collected and the concentration of IL-6, TNF-α, and CRP will be assessed.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 1 months, 2 months
Young Manic Rating Scale (YMSR)
The YMSR assesses the manic symptoms of the subjects.
Measured: Baseline, 1 months, 2 months
Life Event Scale (LES)
The LES assesses the effects of some life events on the subjects.
Measured: 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.
Measured: Baseline, 1 months, 2 months
Hopkins Vocabulary Learning Test-Revised (HVLT-R)
The HVLT-R assesses the memory and the cognition of the subjects.
Measured: Baseline, 1 months, 2 months
Sydney Melancholia Prototype Index (SMPI)
The SMPI aims to identify the melancholic and non-melancholic depression.
Measured: Baseline, 1 months, 2 months
Generalized Anxiety Disoder-7 (GAD-7)
The GAD-7 aims to assesses the severity of anxious symtoms.
Measured: 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.
Measured: Baseline, 1 months, 2 months
Dimensional Anhedonia Rating Scale (DARS)
The DARS assesses different dimensions in Anhedonia of the subjects.
Measured: Baseline, 1 months, 2 months
Child Trauma Scale (CTQ)
The CTQ assesses child trauma happen to the subjects.
Measured: Baseline, 1 months, 2 months
Sheehan Disability Scale (SDS)
The SDS assesses the impairment in the occupational, familial and social ability of the subjects.
Measured: Baseline, 1 months, 2 months
Pittsburgh Sleep Quality Index (PSQI)
The PSQI assesses the sleep quality of the subjects.
Measured: Baseline, 1 months, 2 months
Perceived Deficit Questionnaire for Depression (PDQ-D)
The PDQ-D assesses the perceived deficit of the subjects
Measured: Baseline, 1 months, 2 months
Medication Adherence Rating Scale (MARS)
The MARS assesses the medication adherence condition of the subjects
Measured: 1 months, 2 months
Rating Scale for Side Effects (SERS)
The SERS assesses the side effects of medication condition in the subjects
Measured: 1 months, 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start1 Aug 2019
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lingjiang Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lingjiang Li, Central South University
- Investigators
- Lingjiang Li, MD, Principal investigator, Mental Health Institute, the Second Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04160377
- Sponsor's protocol ID
- 19-08-01-XY-0001
- Status last verified
- Apr 2022
- First submitted
- 8 Nov 2019
- Last updated
- 12 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37304432
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial of Fluvoxamine for Melancholia
- ClinicalTrials.gov ID
- NCT04160377
- Acronym / sponsor ID
- 19-08-01-XY-0001
- Conditions
- Depressive Disorder, Endogenous Depression, Melancholia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Lingjiang LiUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 13 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| melancholic depression | Experimental | Drug: Fluvoxaminepatients with melancholic depression undergo the treatment of Fluvoxamine |
| non-melancholic depression | Experimental | Drug: Fluvoxaminepatients with non-melancholic depression undergo the treatment of Fluvoxamine |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FluvoxamineAlso: Fluvoxamine Maleate TabletsFluvoxamine was assigned to be the treatment for the depression patients with melancholic features or not . | Drug | melancholic depression, non-melancholic depression |
Primary outcome
Change in Hamilton Depression Rating Scale-17 item (HAMD-17)
Time frame: 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 Hamilton Anxiety Rating Scale-14 item (HAMA-14)
Time frame: 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.
Change in voxel-based morphometry of grey matter, white matter as assessed by structural magnetic resonancce imaging
Time frame: 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
Time frame: Baseline, 2 months
Change in Functional connectivity of the brain networks as assessed by measure of connectivity in multimodal MRI.
19 secondary outcomes
Change in peripheral blood cytokines
Time frame: Baseline, 1 months, 2 months
Change in feces bacterial flora
Time frame: Baseline, 1 months, 2 months
Change in Congruent STROOP Time to Complete (Executive Function)
Time frame: Baseline, 1 months, 2 months
Change in DSST (Number of Correct Symbols)
Time frame: Baseline, 1 months, 2 months
Improvement on Snaith-Hamilton Pleasure Scale (SHAPS)
Time frame: Baseline, 1 months, 2 months
Young Manic Rating Scale (YMSR)
Time frame: Baseline, 1 months, 2 months
Life Event Scale (LES)
Time frame: Baseline, 1 months, 2 months
Beck Scale for Suicide Ideation（BSI）
Time frame: Baseline, 1 months, 2 months
Hopkins Vocabulary Learning Test-Revised (HVLT-R)
Time frame: Baseline, 1 months, 2 months
Sydney Melancholia Prototype Index (SMPI)
Time frame: Baseline, 1 months, 2 months
Generalized Anxiety Disoder-7 (GAD-7)
Time frame: Baseline, 1 months, 2 months
Self-reported Quick Inventory of Depressive Symptomatology (QIDS-SR) Scale
Time frame: Baseline, 1 months, 2 months
Dimensional Anhedonia Rating Scale (DARS)
Time frame: Baseline, 1 months, 2 months
Child Trauma Scale (CTQ)
Time frame: Baseline, 1 months, 2 months
Sheehan Disability Scale (SDS)
Time frame: Baseline, 1 months, 2 months
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, 1 months, 2 months
Perceived Deficit Questionnaire for Depression (PDQ-D)
Time frame: Baseline, 1 months, 2 months
Medication Adherence Rating Scale (MARS)
Time frame: 1 months, 2 months
Rating Scale for Side Effects (SERS)
Time frame: 1 months, 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Derived from this study: PubMed 37304432Li 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lingjiang Li, MD principal investigator
Mental Health Institute, the Second Xiangya Hospital of Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fluvoxamine in people with Depressive Disorder and Endogenous Depression, run by Lingjiang Li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xueqin Li (0086-15015102836, 876659651@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hamilton Depression Rating Scale-17 item (HAMD-17) (time frame: Baseline, 2weeks, 1 months, 2 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04160377, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022; AzTrials last refreshed its copy on 7 Nov 2026.