NCT00854919

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 (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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jan 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 3, 2009

Completed
Last Updated

March 3, 2009

Status Verified

December 1, 2005

Enrollment Period

1.9 years

First QC Date

March 2, 2009

Last Update Submit

March 2, 2009

Conditions

SSRI-Refractory Obsessive-Compulsive Disorder

Keywords

obsessive-compulsive disorderaugmentation treatmentSSRI-refractory

Outcome Measures

Primary Outcomes (1)

  • Yale-Brown Obsessive-Compulsive Scale

    1 year

Secondary Outcomes (2)

  • yale-Brown Obsessive-Compulsive Scale

    1 year

  • BMI, TG, T-CHO, FBS

    1 year

Study Arms (3)

CBT

EXPERIMENTAL

All subjects received cognitive-behavioral therapy (CBT) during the study period.

Behavioral: exposure response prevention

1

EXPERIMENTAL

Drug; Paroxetine (30-50mg/D)or Fluvoxamine (150-250mg/D), 1-year administration

Drug: atypical antipsychotic drugBehavioral: exposure response prevention

2

ACTIVE COMPARATOR

Either risperidone (1-5mg/D), olanzapine (1-5mg/D) or quetiapine (25-100mg/D) was added to ongoing SSRI, the combination trial was continued at least for half a year.

Drug: atypical antipsychotic drugBehavioral: exposure response prevention

Interventions

atypical antipsychotic drugDRUG

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).

12
exposure response preventionBEHAVIORAL

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.

12CBT

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Current clinically significant medical conditions such as diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Neuropsychiatry, Osaka City University, graduate School of Medicine

Osaka, Osaka, 545-8585, Japan

Location

Related Publications (1)

  • Matsunaga H, Nagata T, Hayashida K, Ohya K, Kiriike N, Stein DJ. A long-term trial of the effectiveness and safety of atypical antipsychotic agents in augmenting SSRI-refractory obsessive-compulsive disorder. J Clin Psychiatry. 2009 Jun;70(6):863-8. doi: 10.4088/JCP.08m04369. Epub 2009 May 5.

    PMID: 19422759DERIVED

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 4
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 2, 2009

First Posted

March 3, 2009

Study Start

January 1, 2006

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

March 3, 2009

Record last verified: 2005-12

Locations

JP(1)