Aripiprazole in the Treatment of Patients With Schizophrenia and Symptoms of Obsessive Compulsive Disorder (OCD)

NCT ID: NCT00374348

Last Updated: 2011-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2008-05-31

Brief Summary

To evaluate the effectiveness of flexible doses (15-30mg) of Aripiprazole in the treatment of patients with schizophrenia and co-morbid symptoms of OCD in the outpatient setting. The overall effectiveness of Aripiprazole will be evaluated by use of the Brief Psychiatric Rating Scale(BPRS), Yale-Brown OCD scale and Clinical Global Impression-Improvement(CGI-I) scale.

Detailed Description

Symptoms of OCD is a rather common co-morbid condition in patients with Schizophrenia. Some studies suggest that obsessive-compulsive symptoms may be present in 7.8-46% of schizophrenic patients and who seem to be poorly responsive to drug therapy. The serotonergic medications in combination with cognitive-behavioral therapy stil remain the preferred treatment for OCD symptoms. There are controversial data regarding effect of neuroleptics on symptoms of OCD. It was noted that the use of Risperdone, Quatiapine and Clozapine might aggravate OCD symptoms. Serotonin antagonism of these neuroleptics is believed to exacerbate obsessive-compulsive symptoms in schizophrenia. On the other hand, Pourovsky M. at(2000) reported three cases of Schizophrenia with symptoms of OCD successfully treated with Olanzapine.One of our patients with Schizophrenia and co-morbid symptoms of OCD who was unsuccessfully treated with various neuroleptics in combination with anti-obsessive agents,demonstrated significant improvement in both Schizophrenic and obsessive compulsive symptoms after she was switched to Aripiprazole. This result encouraged us to initiate pilot study of effectiveness of Aripiprazole in the treatment of specific population of schizophrenic patients with symptoms of OCD.

Conditions

Schizophrenia OCD; Obsessive Compulsive Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Aripiprazole

Abilify, 5mg; 10mg; 15mg; 20mg; 30mg

Intervention Type: DRUG

Other Intervention Names

Abilify

Eligibility Criteria

Inclusion Criteria

• Man and Women 18-65 years of age.
• Patients who are capable of giving Informed Consent and fluent in English.
• Patients who have DSM IV -Diagnosis of schizophrenia with co-morbid OCD symptoms and BPRS score averaging from mild to moderate (3-4).
• Patients whose obsessive symptoms are not optimally controlled and require a change of treatment.YBOCS score of more than 16.

Exclusion Criteria

• Outside the age range of 18-65 years.
• Patients with current evidence(past three months) of substance abuse.
• Women of child bearing age who are unwilling to use acceptable methods of contraception.
• Patients who have had recent treatment with long-acting antipsychotic.
• Patients who are suicidal or who have history of recent suicidal attempt.
• History of significant medical condition e.g. seizures, cardiovascular, endocrine,gastrointestinal,renal or respiratory diseases.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

Department of Psychiatry, Jamaica Hospital Medical Center

UNKNOWN

Sponsor Role: collaborator

Research Division

AMBIG

Sponsor Role: collaborator

Jamaica Hospital Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Department of Psychiatry Research Division

Principal Investigators

Isak Isakov, M.D.

Role: PRINCIPAL_INVESTIGATOR

Jamaica Hospital Medical Center

Locations

Jamaica Hospital Medical Center Department of Psychiatry

Jamaica, New York, United States

Countries

United States

Other Identifiers

JH-PSY-Aripiprazole/Schiz/OCD

Identifier Type: -

Identifier Source: org_study_id