A study of the efficacy of milnacipran in patients with major depressive disorder (MDD) after SSRI treatment failure, and biological research for MDD using peripheral blood.

A study of the efficacy of milnacipran in patients with major depressive disorder (MDD) after SSRI treatment failure, and biological research for MDD using peripheral blood. - A study of the efficacy of milnacipran in patients with major depressive disorder (MDD) after SSRI treatment failure, and biological research for MDD using peripheral blood.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003516

Enrollment

Registered

2010-04-21

Start date

2010-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major depressive disorder

Interventions

Switching from prior SSRI (fluvoxamine, paroxetine, sertraline, or escitalopram) to milnacipran. This is a 24-week trial.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Subjects with current DSM-IV Major Depressive Disorder 2) Written informed consent by patients and more than 19 years old, less than 75 years old 3) unremitted patients by a SSRI(paroxetine, fluvoxamine, sertraline or escitalopram) for six more weeks 4) The score of 17-item Hamilton Depression Rating Scale (HDRS) is 14 or more.

Exclusion criteria

Exclusion criteria: 1) treating with selegiline hydrochloride 2) Allergy against milnacipran 3) patients with urinary retension 4) pregnant or breast-feeding women or women, who may be pregnant 5) significant risk of suicide 6) patients with dementia, bipolar or psychotic disorders, those with a primary diagnosis of obsessive-compulsive disorder or an eating disorder. 7) Patient whom examination doctor judge improper as a trial subject

Design outcomes

Primary

Measure	Time frame
Exploratory examination of short- and long-term effects of switching to milnacipran on the relationship between clinical outcomes and blood molecules levels.	—

Secondary

Measure	Time frame
1) The rate of Response by Hamilton Depression Rating Scale (HDRS-17) 2) The rate of Remission by Hamilton Depression Rating Scale (HDRS-17) 3) The rate continuation of treatment 4) Remission and response rate by QIDS-SR 5) Social Adaptation Self-evaluation Scale (SASS). 6) Clinical Global Inpression (CGI). 7) Montogomery-Asberg Depression rating Scale (MADRS). 8) Safety 9) Neurotransmitters, Neuropeptide, and others in peripheral blood.	—

Measure

Time frame

1) The rate of Response by Hamilton Depression Rating Scale (HDRS-17) 2) The rate of Remission by Hamilton Depression Rating Scale (HDRS-17) 3) The rate continuation of treatment 4) Remission and response rate by QIDS-SR 5) Social Adaptation Self-evaluation Scale (SASS). 6) Clinical Global Inpression (CGI). 7) Montogomery-Asberg Depression rating Scale (MADRS). 8) Safety 9) Neurotransmitters, Neuropeptide, and others in peripheral blood.

—

Countries

Japan

Contacts

Public ContactTasuku Hashimoto

Chiba University Graduate School of Medicine Department of Psychiatry

t-hashimoto@faculty.chiba-u.jp+81-43-226-2148

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026