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Aripiprazole in the Treatment of Patients With Schizophrenia and Symptoms of Obsessive Compulsive Disorder (OCD)
This study has been completed.
Sponsor:
Jamaica Hospital Medical Center
Collaborators:
Bristol-Myers Squibb
Department of Psychiatry, Jamaica Hospital Medical Center
Research Division
Information provided by:
Jamaica Hospital Medical Center
ClinicalTrials.gov Identifier:
NCT00374348
First received: September 7, 2006
Last updated: September 15, 2011
Last verified: January 2009
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Purpose
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 | Intervention |
|---|---|
| Schizophrenia OCD Obsessive Compulsive Disorder | Drug: Aripiprazole |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | "Aripiprazole in the Treatment of Patients With Schizophrenia and Symptoms of Obsessive Compulsive Disorder (OCD)". |
Resource links provided by NLM:
Genetics Home Reference related topics:
schizophrenia
Drug Information available for:
Aripiprazole
U.S. FDA Resources
Further study details as provided by Jamaica Hospital Medical Center:
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 [ Time Frame: 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 [ Time Frame: weekly ]
| Enrollment: | 10 |
| Study Start Date: | March 2005 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: Aripiprazole
Abilify, 5mg; 10mg; 15mg; 20mg; 30mg
Other Name: Abilify
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00374348
Please refer to this study by its ClinicalTrials.gov identifier: NCT00374348
Locations
| United States, New York | |
| Jamaica Hospital Medical Center Department of Psychiatry | |
| Jamaica, New York, United States, 11418 | |
Sponsors and Collaborators
Jamaica Hospital Medical Center
Bristol-Myers Squibb
Department of Psychiatry, Jamaica Hospital Medical Center
Research Division
Investigators
| Principal Investigator: | Isak Isakov, M.D. | Jamaica Hospital Medical Center |
More Information
| Responsible Party: | Isak Isakov, MD, Department of Psychiatry Research Division |
| ClinicalTrials.gov Identifier: | NCT00374348 History of Changes |
| Other Study ID Numbers: |
JH-PSY-Aripiprazole/Schiz/OCD |
| Study First Received: | September 7, 2006 |
| Last Updated: | September 15, 2011 |
Keywords provided by Jamaica Hospital Medical Center:
|
Schizophrenia with OCD Schizophrenia with-comorbid symptoms of Obsessive Compulsive Disorder(OCD) |
Additional relevant MeSH terms:
|
Disease Schizophrenia Compulsive Personality Disorder Obsessive-Compulsive Disorder Pathologic Processes Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Personality Disorders |
Anxiety Disorders Aripiprazole Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Psychotropic Drugs |
ClinicalTrials.gov processed this record on July 24, 2017