UMIN-CTR Clinical Trial

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

Refractory obsessive-compulsive disorder

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Interventional

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

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

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

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

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

Institute

Hyogo College of Medicine

Institute

Department

Personal name

Organization

Hyogo College of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

01

Month

16

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2012

Year

01

Month

16

Day

Last modified on

2013

Year

07

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008299