UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007455
Receipt No. R000008787
Scientific Title Effectiveness of aripiprazole augmentation therapy in patients with bipolar depression who do not respond to mood stabilizers: A randomized, double-blind, placebo-controlled study
Date of disclosure of the study information 2012/04/01
Last modified on 2015/03/07

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effectiveness of aripiprazole augmentation therapy in patients with bipolar depression who do not respond to mood stabilizers: A randomized, double-blind, placebo-controlled study
Acronym Effectiveness of AripipRazole THerapy in Bipolar Depression (EARTH BD)
Scientific Title Effectiveness of aripiprazole augmentation therapy in patients with bipolar depression who do not respond to mood stabilizers: A randomized, double-blind, placebo-controlled study
Scientific Title:Acronym Effectiveness of AripipRazole THerapy in Bipolar Depression (EARTH BD)
Region
Japan

Condition
Condition Treatment resistant bipolar depression
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 We examine the efficacy of aripiprazole augmentation in patients with bipolar depression who had inadequate response to mood stabilizers using a randomized, double-blind, placebo-controlled study.
We also evaluate the safety of aripiprazole and the effects of plasma catecholamine metabolites, plasma brain- derived neurotrophic factor, plasma cytokines (IL-6, IL-2, IL-1beta, TNF-alpha) and gene polymorphisms on aripiprazole to predict response to the treatment in this study.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 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).
Key secondary outcomes 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)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The patients receive single-blind, adjunctive placebo for 2 weeks after patients achieve adequate dose or target blood levels. When it is not fully responded with mood stabilizers (lithium valproate, lamotorigine), aripiprazole is added for 8 weeks in patients with bipolar depression.
Interventions/Control_2 The patients receive single-blind, adjunctive placebo for 2 weeks after patients achieve adequate dose or target blood levels. When it is not fully responded with mood stabilizers (lithium, valproate, lamotorigine), placebo is added for 8 weeks in patients with bipolar depression.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria 1) Screening phase
Patients who meet DMS-IV-TR criteria for bipolar disorder
Both male and female outpatients/inpatients aged at 18-65 years.
Patients who have a MADRS total score of 20 or greater and a YMRS total score of 12 or less at baseline.
Patients who have received mood stabilizers (Li, VPA, or LTG) for 4 weeks prior to this study.
Patients who have achieved serum Li levels of 0.7 mEq/L or blood VPA levels of 50 ug/mL..
Patients who have received LTG at 200 mg/day or greater for 2 weeks.
Patients providing written informed consent.

2) Double-blind phase (adjunctive phase)
Patients who meet the above inclusion criteria.
Patients who have a MADRS total score of 20 or greater and a YMRS total score of 12 or less at baseline.
Patients who have less than 20% improvement in MADRS for the screening phase.
Key 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.
Target sample size 93

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name MASAKI KATO
Organization Kansai Medical University
Division name Department of Neuropsychiatry
Zip code
Address 11-15 Fumizonocho Moriguchi, Osaka
TEL 06-6992-1001
Email katom@takii.kmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name MASAKI KATO
Organization Kansai Medical University
Division name Department of Neuropsychiatry
Zip code
Address 10-15, Fumizono-cho, Moriguchi City, Osaka
TEL 06-6992-1001
Homepage URL
Email katom@takii.kmu.ac.jp

Sponsor
Institute Kansai Medical University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Psychiatry, University of Occupational and Environmental Health
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 関西医科大学(大阪府)         Kansai Medical University
産業医科大学 (福岡県)     University of Occupational and Environmental Health

Other administrative information
Date of disclosure of the study information
2012 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 08 Month 01 Day
Last follow-up date
2014 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 03 Month 06 Day
Last modified on
2015 Year 03 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008787

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.