The randomized controlled trial about searching for the predictive factor for the response of second-line medication (switching or augmentation) after the first-line medication failure to major depressive disorder patients.

The randomized controlled trial about searching for the predictive factor for the response of second-line medication (switching or augmentation) after the first-line medication failure to major depressive disorder patients. - Prediction of Response to AntiDepressAnt: PRADA study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000016096

Enrollment

200

Registered

2014-12-31

Start date

2014-04-01

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

Switching to Duloxetine treatment from Escitalopram treatment Augmentation by Aripiprazole from Escitalopram monotherapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: A) Major depressive episode was diagnosed using the Structured Clinical interview for the Diagnostic and Statistical Manual of Mental Disorders-fourth edition (DSM-IV) according to DSM-IV text revision (DSM-IV-TR) criteria. B) First, 8 weeks treatment by SSRI (Escitalopram) is performed for the patients who have not any experience of treatment by antidepressant in PRADA 1st . Next, the patients who could not achieve remission by treatment in PRADA 1st are enrolled in PRADA 2nd . C) The severity of depression was evaluated using the 17-item Hamilton Rating Scale for Depression (HAMD17). The patients whose HAMD17 scores were 15 or more were enrolled in this study. D) The patients who could get consent by free will in a document were enrolled in this study.

Exclusion criteria

Exclusion criteria: The patients who have any history of neurological diseases or other physical diseases. The patients who have comorbidities with other disorders, bipolar disorder or Axis II, personality disorders and mental retardation. The patients who have drug allergy or physical idiosyncrasy. The patients who have previous history of substance dependence or alcohol dependence. The patients who have previous history of psychiatric illness that needs medication. The patients who judged that doctor was unsuitable.

Design outcomes

Primary

Measure	Time frame
Hamilton Depression Rating Scale: HAM-D	—

Secondary

Measure	Time frame
Clinical Global Improvement-Severity(CGI-S) Quick Inventory of Depressive Symptomatology(QIDS-J) Udvalg for Kliniske Undersogelser(UKU) Working memory task and Verbal fluency task in Brief Assessment of Cognition in Schizophrenia(BACS-J)	—

Countries

Japan

Contacts

Public ContactKiyokazu Atake

University of Occupational and Environmental Health Department of psychiatry

k-atake@med.uoeh-u.ac.jp+81-936917253

Outcome results

None listed

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