A Clinical Trial of Fluvoxamine for Melancholia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2022-09-30

Brief Summary

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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.

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Detailed Description

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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

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Depressive Disorder Endogenous Depression Melancholia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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melancholic depression

patients with melancholic depression undergo the treatment of Fluvoxamine

Group Type EXPERIMENTAL

Fluvoxamine

Intervention Type DRUG

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

non-melancholic depression

patients with non-melancholic depression undergo the treatment of Fluvoxamine

Group Type EXPERIMENTAL

Fluvoxamine

Intervention Type DRUG

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

Interventions

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Fluvoxamine

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

Intervention Type DRUG

Other Intervention Names

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Fluvoxamine Maleate Tablets

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes