Effectiveness of aripiprazole augmentation in selective serotonin reuptake inhibitor-refractory obsessive-compulsive disorder with poor insight

Not Applicable

• Conditions: Refractory obsessive-compulsive disorder

• Registration Number: JPRN-UMIN000007069
• Lead Sponsor: Hyogo College of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-16
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)