Investigation of biological and clinical predictor of antidepressant response for personalized medicine in depression ; a randomized controlled trial

Investigation of biological and clinical predictor of antidepressant response for personalized medicine in depression ; a randomized controlled trial - Genotype Utility Needed for Depression Antidepressant Medication (GUNDAM)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006417

Enrollment

300

Registered

2011-09-27

Start date

2011-09-01

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 depression

Interventions

Depressive patients are randomly assigned to either mirtazapine or SSRIs. Non-responders after 4-week treatment are randomly assigned to either maintain the same treatment or augmentation. Augment

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Drug naive patient (between 18 and 75 years old) with depression defined by DSN-IV whose HAM-D score are at least 14 .

Exclusion criteria

Exclusion criteria: Subjects with clinically significant unstable medical illness, pregnancy, a principal psychiatric diagnosis other than major depression, a history of substance abuse or dependence active within the previous 6 months, and electroconvulsive therapy within the previous 6 months were excluded.

Design outcomes

Primary

Measure	Time frame
Improvement of depressive symptom assessed by HAM-D	—

Secondary

Measure	Time frame
Adverse effect assessed by UKU QIDS NEO personality inventory Social-cognitive function	—

Countries

Japan

Contacts

Public ContactMasaki Kato

Kansai Medical University Department of Neuropsychiatry

pangaea1975@yahoo.co.jp69921001

Outcome results

None listed

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