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Aripiprazole Augmentation Versus Switching to Different Class of Antidepressants in Major Depressive Disorder

NCT01488266 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2011-12-08

No results posted yet for this study

Summary

The objective of this study is to compare the efficacy and safety of aripiprazole as adjunctive therapy versus switching to different class of antidepressants for treating major depressive disorder partially or minimally responsive to ongoing antidepressant treatment.

Conditions

Interventions

DRUG

Aripiprazole

patients who are randomly assigned to adjunctive aripiprazole are treated with a starting dose of 2.5 (or 5) mg/day of aripiprazole, which can be increased weekly in 2.5\~5mg/day increments to a maximum dose of 15 mg/day based on assessment of tolerability and clinical response. Doses can be decreased at any visit, based on tolerability; They continue to receive the same fixed-dose of the previously used antidepressant throughout the study period when patient is assigned to aripiprazole augmentation group.

DRUG

switching to different class of antidepressant

Patients randomly assigned to switching to different antidepressant have to discontinue the previously used antidepressant and receive different antidepressant within flexible therapeutic doses as indication label information (as based on clinicians' preference and experience). Dose increase is permitted until the first 2 weeks of the study.

Sponsors & Collaborators

  • Korea OIAA

    collaborator UNKNOWN

  • Taiwan Otsuka Pharm. Co., Ltd

    collaborator INDUSTRY

  • Korea University

    lead OTHER

Principal Investigators

  • Changsu Han, MD,PhD, MHS · Korea Univ Ansan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2013-01-31
Completion
2013-03-31

Countries

  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01488266 on ClinicalTrials.gov