obsessive-compulsive disorder
Conditions
Interventions
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 meth
Sponsors
Kyushu University
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change of Y-BOCS total score from baseline to study end. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactTomohiro Nakao
Graduate School of Medical Sciences, Kyushu University Department of Neuropsychiatry
Outcome results
None listed