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Efficacy and safety of blonanserin augmentationtherapy for treatment resistance in depression

Efficacy and safety of blonanserin augmentationtherapy for treatment resistance in depression - Efficacy and safety of blonanserin augmentationtherapy for treatment resistance in depression

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000019990
Enrollment
20
Registered
2015-11-30
Start date
2014-08-01
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

Blonanserin 1-4 mg will be orally administered once daily after dinner for 8 weeks. (initial dose: 1mg, maximum dose: 6mg)

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: aripiprazole 3-15mg

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 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
The Hamilton Rating Scale for Depression assessment at the 8 weeks after the start of interventions

Secondary

MeasureTime frame
Udvalg for kliniske undersogelser side effect rating scale, Drug Induced Extra-Pyramidal Symptons Scale

Countries

Japan

Contacts

Public ContactYuki Matsuda

Fujita Health University School of Medicine Department of Psychiatry

myuki@fujita-hu.ac.jp0562-93-9259

Outcome results

None listed

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