Aripiprazole for the Augmentation of Antidepressant Therapy

Otsuka

Status and phase

Completed

Phase 4

Conditions

Major Depressive Disorder

Treatments

Drug: Aripiprazole

Study type

Interventional

Funder types

Industry

Identifiers

NCT01429831

031-TWB-1101i

Details and patient eligibility

About

The study aims to evaluate effectiveness and tolerability of aripiprazole augmentation in outpatients with major depressive disorder who have had inadequate response to antidepressants in Taiwan clinical practice.

Enrollment

300 patients

Sex

All

Ages

20 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Outpatients, either gender, 20-65 years of age
Patients diagnosed with major depressive disorder as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), who fulfill both the following criteria:
- Having at least one and no more than three inadequate responses of antidepressants
- HAM-D17 score ≥ 14
Willing and able to comply with the study procedure and sign a written informed consent

Exclusion criteria

Females who are pregnant/lactating or planning to be pregnant
Presence of personality disorder cluster B (dramatic, emotional or erratic disorders) or any psychotic symptomatology in the current depressive episode based on Investigators judgment
History of organic mental disorder within 1 year prior to the screening visit
Acute risk of suicide attempts within 3 months prior to the initiation of study treatment (HAM D-17 score item 3 ≥ 3)
Electroconvulsive therapy (ECT) for current episode
Past exposure to aripiprazole treatment or any investigational product (including drug and invasive medical device) within 4 weeks prior to the initiation of study treatment
History of substance / alcohol abuse within 1 year prior to the screening visit
Patient with any medical or psychotic feature, including the presence of significant abnormal laboratory values, which is considered not suitable for this study by Investigator