Effectiveness and Safety of Atypical Antipsychotic Agents in Augmenting SSRI-Refractory Obsessive-Compulsive Disorder

SSRI-Refractory Obsessive-Compulsive Disorder Clinical Trial

— OCDDRUG  

Official title:

An Long Term Trial on Effectiveness and Safety of Atypical Antipsychotic Agents in Augmenting SSRI-Refractory Obsessive-Compulsive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00854919
• Other study ID #: 18591305
• Status: Completed
• Phase: Phase 4
• First received: March 2, 2009
• Last updated: March 2, 2009
• Start date: January 2006
• Est. completion date: December 2007

Study information

• Verified date: December 2005
• Source: Osaka City University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Education, Culture, Sports, Science and Technology
• Study type: Interventional

Clinical Trial 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 (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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• Male or female, 18 years of age or over

• Patients were diagnosed as having obsessive-compulsive disorder by the Structured Clinical Interview for DSM-IV Patient version (SCID-P)

• They received standardized treatment for at least 1 year at the OCD clinic in our university hospital.

• Each subject gave written informed consent to take part after receiving a complete description of this study.

• All subjects were free of medical illness based on results of physical examination and screening tests of blood and urine, and no subjects received any lipid lowering or hypoglycemic agent during the 1-year study period.

Exclusion Criteria:

• Current clinically significant medical conditions such as diabetes

Study Design

N/A

Related Conditions & MeSH terms

• Compulsive Behavior
• Obsessive-Compulsive Disorder
• SSRI-Refractory Obsessive-Compulsive Disorder

Intervention

Drug:
• atypical antipsychotic drug
For SSRI-refractory group, either atypical antipsychotic such as mean doses of RIS (3.1±1.9mg/day), of OLZ (5.1±3.2mg/day), and of QET (60.0±37.3mg/day) was added on ongoing SSRI(Paroxetine, Fluvoxamine).

Behavioral:
• exposure response prevention
After at least 12 weeks from treatment initiation, cognitive-behavioral therapy (CBT) using exposure and response prevention was added with psychoeducational interventions and behavioral analysis.

Locations

Country	Name	City	State
Japan	Dept of Neuropsychiatry, Osaka City University, graduate School of Medicine	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Osaka City University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Yale-Brown Obsessive-Compulsive Scale		1 year	No
Secondary	yale-Brown Obsessive-Compulsive Scale		1 year	No
Secondary	BMI, TG, T-CHO, FBS		1 year	Yes