Efficacy and tolerability comparing switching escitalopram to mirtazapine and mirtazapine augmentation to escitalopram with major depressive disorder with insufficiency in escitalopram. A randomized rater blinded randomized controlled trial.

Efficacy and tolerability comparing switching escitalopram to mirtazapine and mirtazapine augmentation to escitalopram with major depressive disorder with insufficiency in escitalopram. A randomized rater blinded randomized controlled trial. - Efficacy and tolerability comparing switching escitalopram to mirtazapine and mirtazapine augmentation to escitalopram with major depressive disorder with insufficiency in escitalopram. A randomized rater blinded randomized controlled trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000024906

Enrollment

Registered

2016-11-19

Start date

2016-11-19

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 5-20mg/day of escitalopram to 15-45mg/day of mirtazapine. Augmentation of 15-45mg/day of mirtazapine to 5-20mg/day of escitalopram.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients provided written informed consent. 2.Legal representative provided informed consent if the patient has poor judgement. 3.Diagnosis of major depressive disorder based on Diagnostic and Statistical Manual of Mental Disorders, fourth edition. 4.Scores of Hamilton Rating Scale for Depression 17 items are over 12 points with more than 2 weeks of approved dose of escitalopram.

Exclusion criteria

Exclusion criteria: 1.Patients diagnosed as pervasive development disorder, schizophrenia and related psychosis, bipolar disorder, or obsessive compulsive disorder on axis one of the Diagnostic and Statistical Manual of Mental Disorders,fourth edition.(using the structured clinical interview for DSM-four axis one disorders) 2.Patients diagnosed as personality disorder or mental retardation on axis two of the Diagnostic and Statistical Manual of Mental Disorders,fourth edition. 3.Patients diagnosed as substance abuse or dependence.(but,dependence of nicotine or caffeine are inclusive) 4.Patients having allergy for escitalopram or mirtazapine. 5.Patients taking monoamine oxidase inhibitor within 2 weeks. 6.Patients taking pimozide 7.Patients diagnosed QTc prolongation (congenital long QT syndrome) 8.Patients treated with electroconvulsive therapy within 6 months 9.Patients diagnosed severe disease with liver, kidney, blood, respiratory organ, digestive organ, abnormality in metabolism and electrolytes or hypersensitivity. 10.Patients taking treatment for physical disease. 11.Patients who may be pregnant and pregnant. 12.Patients judged high risk for suicide. 13.Patients attempted suicide. 14.Patients judged inappropriate for participation by researchers.

Design outcomes

Primary

Measure	Time frame
Difference in remission rate between escitalopram to mirtazapine switching group and mirtazapine augmentation to escitalopram group from baseline to week 12.	—

Countries

Japan

Contacts

Public ContactKazuto Oya

Fujita Health University department of psychiatry

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

Outcome results

None listed

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