Aripiprazole in the Treatment of Patients With Schizophrenia and Symptoms of Obsessive Compulsive Disorder (OCD)
Primary Purpose
Schizophrenia OCD, Obsessive Compulsive Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aripiprazole
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia OCD focused on measuring Schizophrenia with OCD, Schizophrenia with-comorbid symptoms of Obsessive Compulsive Disorder(OCD)
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.
Sites / Locations
- Jamaica Hospital Medical Center Department of Psychiatry
Outcomes
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
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
Full Information
NCT ID
NCT00374348
First Posted
September 7, 2006
Last Updated
September 15, 2011
Sponsor
Jamaica Hospital Medical Center
Collaborators
Bristol-Myers Squibb, Department of Psychiatry, Jamaica Hospital Medical Center, Research Division
1. Study Identification
Unique Protocol Identification Number
NCT00374348
Brief Title
Aripiprazole in the Treatment of Patients With Schizophrenia and Symptoms of Obsessive Compulsive Disorder (OCD)
Official Title
"Aripiprazole in the Treatment of Patients With Schizophrenia and Symptoms of Obsessive Compulsive Disorder (OCD)".
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Jamaica Hospital Medical Center
Collaborators
Bristol-Myers Squibb, Department of Psychiatry, Jamaica Hospital Medical Center, Research Division
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia OCD, Obsessive Compulsive Disorder
Keywords
Schizophrenia with OCD, Schizophrenia with-comorbid symptoms of Obsessive Compulsive Disorder(OCD)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Other Intervention Name(s)
Abilify
Intervention Description
Abilify, 5mg; 10mg; 15mg; 20mg; 30mg
Primary Outcome Measure Information:
Title
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
Time Frame
weekly
Secondary Outcome Measure Information:
Title
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
Time Frame
weekly
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isak Isakov, M.D.
Organizational Affiliation
Jamaica Hospital Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jamaica Hospital Medical Center Department of Psychiatry
City
Jamaica
State/Province
New York
ZIP/Postal Code
11418
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Aripiprazole in the Treatment of Patients With Schizophrenia and Symptoms of Obsessive Compulsive Disorder (OCD)
We'll reach out to this number within 24 hrs