Effectiveness of aripiprazole augmentation therapy in patients with bipolar depression who do not respond to mood stabilizers: A randomized, double-blind, placebo-controlled study

Not Applicable

• Conditions: Treatment resistant bipolar depression

• Registration Number: JPRN-UMIN000007455
• Lead Sponsor: Kansai Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-04-01
• Study Completion: 2014-09-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 93

Inclusion Criteria

Not provided

Exclusion Criteria

Patients who meet DSM-IV-TR for significant Axis I and II disorders except bipolar disorder. Patients who received antipsychotics or antidepressants within 4 weeks prior to screening phase. Patients who have a ECT therapy within 3 months prior to screening phase. Patients who are comatose and strongly affected by central nervous system depressants such as barbiturates or anesthetics. Patients who have received adrenaline. Patients known to have a history or complication of allergy to aripiprazole. Patients with a history or a complication of diabetes. Women who are pregnant, possibly pregnant, or breast-feeding. Patients who have been judged by the investigator to be inappropriate for inclusion in the trial for any other reasons Patients who have a complication of serious physical disorder. Patients who have been judged by the investigators to have a high risk of suicide.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean change of Montgomery-Asberg Depression Rating Scale (MADRS) for 8 weeks in double-blind phase (from Week 2 to Week 10) in aripiprazole group and placebo group (LOCF).

Secondary Outcome Measures

Name	Time	Method
Mean change of The Japanese version of Young Mania rating scale (YMRS-J), Clinical global impression;Severity (CGI-S) and Quick Inventory of Depressive Symptomatology (QIDS-J) (at Week 2, 6, 10) Mean change of Body mass index (BMI), body weight, and laboratory values (at Week 2, 10)