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Aripiprazole versus duloxetine in combination with mirtazapine for treatment-resistant,major deressive disorder: a rater-masked,randomized trial.

Aripiprazole versus duloxetine in combination with mirtazapine for treatment-resistant,major deressive disorder: a rater-masked,randomized trial. - Aripiprazole versus duloxetine in combination with mirtazapine for treatment-resistant,major deressive disorder:randomized trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000011483
Enrollment
100
Registered
2013-08-14
Start date
2013-08-14
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

Duloxetine Aripiprazole

Sponsors

Department of Psychiatry, Fujita Health University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: DSM-4-TR:MDD Patients with treatment-resistant MDD: HAMD17>15:sufficient dose SSRI (ESC>15mg,PAR>30mg,SER>75mg,FLU>112,5mg) for more than 2 weeks. After that, the patients have no respose (HAMD17>15)to MIR 30mg/day for more than 2 weeks

Exclusion criteria

Exclusion criteria: Patient with the following disorders (based on DSM-IV-TR criteria): psychotic disorders, pervasive developmental disorders, bipolar disorder, obsessive-compulsive disorder, Axis-2 disorder. Patients with substance abuse or dependence (excluding nicotine and caffeine) meeting DSM-IV-TR criteria Patients taking MAO inhibitors with in14 days (or Patients treated with MAO inhibitors within 14 days) Patients taking pimozide Patients with allergies to escitalopram, duloxetine and aripiprazole Patients with QT interval prolongation Patients treated with ECT within the previous 6 months Patients having severe physical disease Patients who are pregnant or may become pregnant Patients at significant risk of suicide (having a score >3 on HAM-D item 11) Patients who had made suicide attempt within the past year

Design outcomes

Primary

MeasureTime frame
Hamilton Raing Scale for Depression

Secondary

MeasureTime frame
discontimuation rate, remission rate, adverse events

Countries

Japan

Contacts

Public ContactTaro Kishi

Fujita Health University School of Medicine Department of Psychiatry

tarok@fujita-hu.ac.jp0562-93-9250

Outcome results

None listed

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