Ignite Creation Date:
2024-05-05 @ 9:18 PM
Last Modification Date:
2024-10-26 @ 10:02 AM
Study NCT ID:
NCT00854919
Status:
COMPLETED
Last Update Posted:
2009-03-03
First Post:
2009-03-02
Brief Title:
Effectiveness and Safety of Atypical Antipsychotic Agents in Augmenting SSRI-Refractory Obsessive-Compulsive Disorder
Sponsor:
Osaka City University
Organization:
Osaka City University
Study Overview
Official Title:
An Long Term Trial on Effectiveness and Safety of Atypical Antipsychotic Agents in Augmenting SSRI-Refractory Obsessive-Compulsive Disorder
Status:
COMPLETED
Status Verified Date:
2005-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OCDDRUG
Brief Summary:
Objective Although atypical antipsychotic drugs AAPDs have been found effective in the augmentation of serotonin reuptake inhibitors SRIs for treatment-resistant obsessive-compulsive disorder OCD in short terms trials there are few data on the effectiveness and safety of these agents in clinical settings over the long term
Method Subjects n46 who responded to selective SRIs SSRIs in an initial 12-week trial were continued on SRI-monotherapy plus cognitive-behavioral therapy CBT for one year Subjects n44 who failed to respond to SSRIs were randomly assigned to one of 3 AAPDs such as risperidone and were consecutively treated using SSRIAAPD combined with CBT for a year
Method Subjects n46 who responded to selective SRIs SSRIs in an initial 12-week trial were continued on SRI-monotherapy plus cognitive-behavioral therapy CBT for one year Subjects n44 who failed to respond to SSRIs were randomly assigned to one of 3 AAPDs such as risperidone and were consecutively treated using SSRIAAPD combined with CBT for a year
Detailed Description:
More recently second-generation atypical antipsychotic drugs AAPD that modulate both 5-HT and DA function such as risperidone RIS olanzapine OLZ and quetiapine QET have been found effective in the augmentation of SSRIs for treatment-resistant OCD
Nevertheless the AAPDs have been associated with common and serious adverse effects such as body weight BW gain and metabolic dysregulation Metabolic dysregulation includes glucoregulatory dysfunction and dyslipidemia Indeed studies of some AAPD in SSRI-refractory OCD patients have similarly reported significant BW gain AAPD-induced BW gain may influence patients adherence to medication and places them at risk for a broad range of medical problems
Most work on AAPDs in treatment-refractory OCD has been conducted in the form of short-term efficacy studies There have been fewer studies of the effectiveness safety and tolerability of these agents in the context of a clinic where CBT is also provided and where treatment is continued for a significant period of time In the current effectiveness study we sought to examine the response of SSRI-refractory patients to augmentation with AAPDs comparing adverse events in such compared to a control group of SSRI responders
Nevertheless the AAPDs have been associated with common and serious adverse effects such as body weight BW gain and metabolic dysregulation Metabolic dysregulation includes glucoregulatory dysfunction and dyslipidemia Indeed studies of some AAPD in SSRI-refractory OCD patients have similarly reported significant BW gain AAPD-induced BW gain may influence patients adherence to medication and places them at risk for a broad range of medical problems
Most work on AAPDs in treatment-refractory OCD has been conducted in the form of short-term efficacy studies There have been fewer studies of the effectiveness safety and tolerability of these agents in the context of a clinic where CBT is also provided and where treatment is continued for a significant period of time In the current effectiveness study we sought to examine the response of SSRI-refractory patients to augmentation with AAPDs comparing adverse events in such compared to a control group of SSRI responders
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None