SSRI-Refractory Obsessive-Compulsive Disorder Clinical Trial
Official title:
An Long Term Trial on Effectiveness and Safety of Atypical Antipsychotic Agents in Augmenting SSRI-Refractory Obsessive-Compulsive Disorder
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 (n=46) 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 (n=44) who failed to respond to SSRIs were randomly assigned to one of 3 AAPDs such
as risperidone and were consecutively treated using SSRI+AAPD combined with CBT for a year.
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.
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