UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000007069
Receipt No. R000008299
Scientific Title Effectiveness of aripiprazole augmentation in selective serotonin reuptake inhibitor-refractory obsessive-compulsive disorder with poor insight
Date of disclosure of the study information 2012/01/16
Last modified on 2013/07/16

* 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 in selective serotonin reuptake inhibitor-refractory obsessive-compulsive disorder with poor insight
Acronym Effectiveness of aripiprazole augmentation in SSRI-refractory OCD with poor insight
Scientific Title Effectiveness of aripiprazole augmentation in selective serotonin reuptake inhibitor-refractory obsessive-compulsive disorder with poor insight
Scientific Title:Acronym Effectiveness of aripiprazole augmentation in SSRI-refractory OCD with poor insight
Region
Japan

Condition
Condition Refractory obsessive-compulsive disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We examine the efficacy of aripiprazole augmentation in obsessive-compulsive disorder (OCD) patients who had not fully responded with at least 2 kinds of selective serotonin reuptake inhibitors (SSRIs) alone for more than 3 months. We also evaluate the safety and tolerability of aripiprazole in this study.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Mean change of Yale-Brown Obsessive-
Compulsive Scale (Y-BOCS) for 8 weeks in adjunctive phase (from Week 4 to Week 12) in aripiprazole adjunctive group and placebo group (LOCF).
Key secondary outcomes Mean change of Clinical global impression-Severity (CGI-S) and CGI-improvement (CGI-I)
(at Week 4, 8, 12)
Mean change of Body mass index (BMI) (at Week 0, 4, 8, 12)
Mean change of FBS, TG, T-CHO
(at Week 0, 4,12)

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 Paroxetine or fluvoxamine at adequate dose is used for 4 weeks. In addition, patients receive single-blind, adjunctive placebo. When it is not responded, aripiprazole is added for 8 weeks in OCD patients who did not fully responded with SSRI alone.
Interventions/Control_2 Paroxetine or fluvoxamine at adequate dose is used for 4 weeks. In addition, patients receive single-blind, adjunctive placebo. When it is not responded, placebo is added for 8 weeks in OCD patients who did not fully responded with SSRI alone.
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 for SSRI-refractory OCD

Patients who meet DMS-IV-TR criteria for OCD and diagnosed for more than 1 year.

Both male and female outpatients/inpatients aged at 18-65 years.

Patients who have not received antipsychotics for 12 weeks prior to this study.

Patients who have ever received both PAX and FLV.

Patients who have treated with SSRI (PAX or FLV) for at least 12 weeks.

Patients who have treated with SSRI at adequate dose (PAX:40mg and over, FLV:200mg and over) for at least 8 weeks.

Patients with less than 15% improvement in Y-BOCS for 12 weeks prior to this study.

Patients who treated with SSRI at adequate dose at baseline.

Patients who have a Y-BOCS total score of 16 or greater at baseline.

Patients providing written informed consent.


2) Adjunctive phase

Patients who meet the above inclusion criteria.

Patients who meet the criteria for refractory OCD: less than 10% improvement in Y-BOCS for the screening phase and 3 (minimally improved) to 7 (very much worse) of CGI-I.
Key exclusion criteria Patients who meet DSM-IV-TR for schizophrenia, schizoaffective disorder, and bipolar disorder.

Patients who have a HAM-D of 21 and greater.

Patients who have significant mental retardation and pervasive development disorder.

Patients who are comatose and strongly affected by centrally-acting suppressants 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.
Target sample size 116

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisato Matsunaga
Organization Hyogo College of Medicine
Division name Department of Neuropsychiatry
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya City, Hyogo Prefecture
TEL 0798-45-6041
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hisato Matsunaga
Organization Hyogo College of Medicine
Division name Department of Neuropsychiatry
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya City, Hyogo Prefecture
TEL
Homepage URL
Email

Sponsor
Institute Hyogo College of Medicine
Institute
Department

Funding Source
Organization Hyogo College of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2012 Year 01 Month 16 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 Terminated
Date of protocol fixation
2011 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 01 Month 16 Day
Last modified on
2013 Year 07 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008299

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.