Refractory obsessive-compulsive disorder
Conditions
Interventions
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 patie
Sponsors
Hyogo College of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Japan
Contacts
Public ContactHisato Matsunaga
Hyogo College of Medicine Department of Neuropsychiatry
Outcome results
None listed