Efficacy of mirtazapine for sleep disturbance and anxiety symptoms compared with selective serotonin reuptake inhibitors in patients with major depressive disorder: a multicenter open-label randomized controlled trial.

Efficacy of mirtazapine for sleep disturbance and anxiety symptoms compared with selective serotonin reuptake inhibitors in patients with major depressive disorder: a multicenter open-label randomized controlled trial. - Efficacy of mirtazapine for sleep disturbance and anxiety symptoms compared with selective serotonin reuptake inhibitors in patients with major depressive disorder: a multicenter, open-label, randomized, controlled trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004144

Enrollment

120

Registered

2010-09-02

Start date

2010-08-01

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

Mirtazapine (15-45 mg/day) will be continued continued for 6 weeks. Follow-up period is 24 weeks. Paroxetine (20-40 mg/day) or Paroxetine controlled-release (25-50 mg/day) will be continued continue

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with current major depressive episode 2. Major depessive diorder by DSM-IV-TR 3. Patients with 12 or over in HDRS-17 4. Patients thought to need antidepressant treatments in the judgment of the consulting psychiatrist 5. Patients with 20-75 years of age at study entry 6. Written informed consent by patients

Exclusion criteria

Exclusion criteria: 1. Patients without 20-75 years of age at study entry 2. Patients treated to current major depressive episode with the antidepressants as the trial intervention 3. Allergy against mirtazapine, paroxetine, and sertraline 4. Patients treated with pimozide 5. Patients treating with or discontinued within 14 days with selegiline, monoamine oxidase inhibitors 6. Patients with severe hormone diseases 7. Significant risk of suicide (HDRS-17 suicide score 3 or over) 8. Pregnant women or women, who may be pregnant 9. Breast-feeding women 10. Patients with substance abuse/dependence 11. Patients with alcohol abuse/dependence 12. Patients with dementia, bipolar or psychotic disorders, those with a primary diagnosis of obsessive-compulsive disorder or an eating disorder 13. Patient whom examination doctor judge improper as a trial subject

Design outcomes

Primary

Measure	Time frame
Rate of patients taking benzodiazepines at 6, 12, and 24 weeks	—

Secondary

Measure	Time frame
1) Response rate by Hamilton Depression Rating Scale(HDRS17) 2) Athene Insomnia Scale (AIS) 3) Zung Self-rating Depression Scale (SDS) 4) Incidence rate of activation syndrome 5) Incidence rate of discontinuation symptoms 6) Clinical Global Inventory (CGI) 7) Serum levels of brain-derived neurotrophic factor (BDNF) at baseline, 6, 12, and 24 weeks 8) five year follow-up of patients	—

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