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

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

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.

Study Overview

• Status: Completed
• Conditions: Obsessive Compulsive Disorder; Schizophrenia OCD
• Intervention / Treatment: Drug: Aripiprazole

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Jamaica, New York, United States, 11418
      • Jamaica Hospital Medical Center Department of Psychiatry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Jamaica Hospital Medical Center
• Collaborators: Bristol-Myers Squibb; Department of Psychiatry, Jamaica Hospital Medical Center; Research Division
• Investigators: Principal Investigator: Isak Isakov, M.D., Jamaica Hospital Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2005
• Primary Completion (Actual): May 1, 2008
• Study Completion (Actual): May 1, 2008

Study Registration Dates

• First Submitted: September 7, 2006
• First Submitted That Met QC Criteria: September 8, 2006
• First Posted (Estimate): September 11, 2006

Study Record Updates

• Last Update Posted (Estimate): September 16, 2011
• Last Update Submitted That Met QC Criteria: September 15, 2011
• Last Verified: January 1, 2009

More Information

Terms related to this study

• Keywords: Schizophrenia with OCD; Schizophrenia with-comorbid symptoms of Obsessive Compulsive Disorder(OCD)
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Schizophrenia Spectrum and Other Psychotic Disorders; Personality Disorders; Anxiety Disorders; Schizophrenia; Disease; Compulsive Personality Disorder; Obsessive-Compulsive Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Antidepressive Agents; Dopamine Agonists; Dopamine Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Aripiprazole
• Other Study ID Numbers: JH-PSY-Aripiprazole/Schiz/OCD