UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007455 |
|---|---|
| Receipt number | 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 10:29:51 |
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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
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
katom@takii.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008787
