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

Sponsor

Jamaica Hospital Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00374348

Collaborator

Bristol-Myers Squibb (Industry), Department of Psychiatry, Jamaica Hospital Medical Center (Other), Research Division (Other)

Enrollment

Location

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia OCD Obsessive Compulsive Disorder	Drug: Aripiprazole	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2005

Actual Primary Completion Date :

May 1, 2008

Actual Study Completion Date :

May 1, 2008

Outcome Measures

Primary Outcome Measures

The overall effectiveness of Aripiprazole will be evaluated by use of the BPRS, Yale-Brown OCD scale and Clinical Global Impression-Improvement (CGI-I) scale, including efficacy in reduction of psychosis and obsessions.Improvements in YBOCS and BPRS scor [weekly]

Secondary Outcome Measures

Physical Examination, Psychiatric evaluation with YBOCS, BPRS and CGI scales, EPS scale, routine hematology and chemistry tests, urinalysis,urine drug screening,urine pregnancy test, ECG recording [weekly]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.