UMIN-CTR Clinical Trial

Public title

Augmentation therapy with aripiprazole in selective serotonin reuptake inhibitor(SSRI)-refractory obsessive-compulsive disorder(OCD); A randomized double blind placebo controlled trial

Acronym

ROCAAS (Randomized controlled trial for OCD of Aripiprazole Augmentation to SSRI) Study

Scientific Title

Augmentation therapy with aripiprazole in selective serotonin reuptake inhibitor(SSRI)-refractory obsessive-compulsive disorder(OCD); A randomized double blind placebo controlled trial

Scientific Title:Acronym

ROCAAS (Randomized controlled trial for OCD of Aripiprazole Augmentation to SSRI) Study

Region

Japan

Condition

obsessive-compulsive disorder

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

An effects and safety of aripiprazole reinforcement therapy in combination with selective serotonin reuptake inhibitors are investigated in aripiprazole 6mg and 12 mg/day of variable dose group and a placebo control group in patients with obsessive-compulsive disorder (OCD).

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

Mean change of Y-BOCS total score from baseline to study end.

Key secondary outcomes

1)Ratio of patients having more than 35% decrease of total Y-BOCS score from baseline to study end.
2)Mean change of total Y-BOCS score among symptom types from baseline to study end.
3)Mean change of DY-BOCS score of every symptom factors from baseline to study end.
4)Mean change of individual score of 10 sub-categories in Y-BOCS from baseline to study end.
5)Mean change of total Y-BOCS score for YGTSS score
6)Patients rate with score 1 and 2 in Clinical global impression-Improvement (CGI-I) from baseline to study end.
7)Mean change of Clinical global impression-Severity (CGI-S) from baseline to study end.
8)Mean change of total Global Assessment of Functioning(GAF) score from baseline to study end.
9)Mean change of total Hamilton Depressive Rating Scale (HAM-D) score from baseline to study end.
10)Mean change of TMT score from baseline to study end.
11)Mean change of Stroop Test score from baseline to study end.
12)Mean change of IGT score from baseline to study end.
13)Mean change of total Y-BOCS score for AQ and ASQ score from baseline to study end.
14)Safety:adverse events, DIEPSS, vital sign (blood pressure, heart rate), BMI, laboratory test and ECG

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Previous SSRI (paroxetine or fluvoxamine) at adequate dose is used for 12 weeks. OCD patients who did not fully responded with SSRI alone receive 6mg/day aripiprazole for 4 weeks in double-blind method in addition to SSRI. A rater who is different from a treatment person in charge performs an evaluation by CGI-I at 4 weeks. If CGI-I score is lower than minimally improved (score 3-7) and there is no problem in tolerability in comparison with study start, patients receive 12 mg/day aripiprazole for 4weeks.

Interventions/Control_2

Previous SSRI (paroxetine or fluvoxamine) at adequate dose is used for 12 weeks. OCD patients who did not fully responded with SSRI alone receive placebo (indistinguishable from 6mg/day aripiprazole) for 8 weeks in double-blind method in addition to SSRI. A rater who is different from a treatment person in charge performs an evaluation by CGI-I at 4 weeks. If CGI-I score is lower than minimally improved (score 3-7) and there is no problem in tolerability in comparison with study start, patients receive placebo (indistinguishable from 12 mg/day aripiprazole) for 4weeks.

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

15

years-old

<=

Age-upper limit

60

years-old

>

Gender

Male and Female

Key inclusion criteria

1)Outpatients/inpatients
2)Both male and female at 15-59 years.
3)Patients providing written informed consent
4) Written informed consent are obtainable from both patients and their guardians in case of a minor patient (more than 15 years and less than 20 years old).
5)Patients who meet SCID criteria for OCD
6)Patients who have treated with SSRI (paroxetine or fluvoxamine ) for at least 12 weeks. Patients who have treated with SSRI at adequate dose (paroxetine: 40-50mg, fluvoxamine: 150-250mg) for at least 8 weeks.
7)Patients who have not enough clinical effects by treatment with more than two kinds of SSRI or SRI.
8)Patients who have a Y-BOCS total score of 17 or greater at baseline and with less than 35% improvement in Y-BOCS with 12 weeks treatment of SSRI alone at the enrollment of this study
9)Patients who have not received antipsychotics for 3months prior to this study

Key exclusion criteria

1)Patient who hopes for the pregnancy in childbearing woman within 4 weeks after during the study.
2)Pregnant woman, patient nursing, patient who may be pregnant
3)Patient with delirium, dementia, amnestic disorder,other cognitive impairment,mental disorder due to general physical disease,
schizophrenia,bipolar disorder, substance-related disorder, agoraphobia, social phobia, panic disorder, specific phobia, PTSD, generalized anxiety disorder, somatoform disorder and eating disorder in I axis diagnosis of DSM-IV-TR.
4)patient with a part of personality disorder and mental retardation in II axis diagnosis of DSM-IV-TR.
5)participated in a clinical trial of other drugs or the medical devices for the past less than 1 month
6)Patient with score of the suicide item of the HAM-D 17 more than 3 points or patient whom PI/sub-investigator judged if at great risk of suicide for a study period from a current mental symptom and a past medical history
7)a history or a complication of diabetes,or judged to be a diabetes type blood sugar level or HbA1C(NGSP)>=6.5%,or FBS level >=126mg/dl,or casual BG level >=200mg/dl
8)history of the paroxysmal disease(epilepsy)
9)history of the obstacle of the intracranial tissue
10)Patient with the history of the paroxysmal disorder
11)Patients who meet the following criteria
*T-Bil:>=3.0mg/dl
*AST,ALT:over 2.5 times of NUL
*CRE: >=2mg/dl
*drug treatment with heart failure,arrhythmia or ischemic heart disease,etc
*RBC:<3x10e6/mm3
*Hb:<10.0g/dl
*WBC:<3,000/mm3
*Plt:<75,000/mm3
12) contraindication of aripiprazole
a)comatose
b)Strongly affected by centrally-acting suppressants such as barbiturates or anesthetics
c)received adrenaline
d)hipersensitivity to aripiprazole
13) Patients who have been judged by the investigator to be inappropriate for inclusion in the trial for any other reasons
14) structured systematic behavior therapy mainly on the revelation reaction interference method

Target sample size

60

Name of lead principal investigator

1st name
Middle name
Last name	Tomohiro Nakao

Organization

Graduate School of Medical Sciences, Kyushu University

Division name

Department of Neuropsychiatry

Zip code

Address

3-1-1 Maidashi Higashi-ku, Fukuoka, Japan

TEL

092-642-5221

Email

tomona@npsych.med.kyushu-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Tomohiro Nakao

Organization

Graduate School of Medical Sciences, Kyushu University

Division name

Department of Neuropsychiatry

Zip code

Address

3-1-1 Maidashi Higashi-ku, Fukuoka, Japan

TEL

092-642-5627

Homepage URL

Email

tomona@npsych.med.kyushu-u.ac.jp

Institute

Kyushu University

Institute

Department

Personal name

Organization

The Japanese Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

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

九州大学病院（福岡県）

Date of disclosure of the study information

2013

Year

03

Month

02

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

2013

Year

09

Month

20

Day

Date of IRB

Anticipated trial start date

2013

Year

10

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

08

Month

21

Day

Last modified on

2016

Year

12

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010229