UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Augmentation therapy with aripiprazole in selective serotonin reuptake inhibitor(SSRI)-refractory obsessive-compulsive disorder(OCD); A randomized double blind placebo controlled trial
Title of the study (Brief title)	ROCAAS (Randomized controlled trial for OCD of Aripiprazole Augmentation to SSRI) Study
Region	Japan

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

Objectives
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

Assessment
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

Base
Study type	Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
Name of lead principal investigator	Tomohiro Nakao
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Department of Neuropsychiatry
Address	3-1-1 Maidashi Higashi-ku, Fukuoka, Japan
TEL	092-642-5221
Email	tomona@npsych.med.kyushu-u.ac.jp

Public contact
Name of contact person	Tomohiro Nakao
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Department of Neuropsychiatry
Address	3-1-1 Maidashi Higashi-ku, Fukuoka, Japan
TEL	092-642-5627
Homepage URL
Email	tomona@npsych.med.kyushu-u.ac.jp

Sponsor
Institute	Kyushu University
Institute
Department

Funding Source
Organization	The Japanese Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	九州大学病院（福岡県）

Other administrative information
Date of disclosure of the study information	2013 Year 03 Month 02 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 09 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 08 Month 21 Day
Last modified on	2016 Year 12 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010229