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

Sponsors and Collaborators:	Jamaica Hospital Medical Center Bristol-Myers Squibb Jamaica Hospital Medical Center Department of Psychiatry Research Division
Information provided by:	Jamaica Hospital Medical Center
ClinicalTrials.gov Identifier:	NCT00374348

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

MedlinePlus related topics: Obsessive-Compulsive Disorder Schizophrenia

Drug Information available for: Aripiprazole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	"Aripiprazole in the Treatment of Patients With Schizophrenia and Symptoms of Obsessive Compulsive Disorder (OCD)".

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]

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:

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

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
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

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

Jamaica Hospital Medical Center Department of Psychiatry

Research Division

Investigators

Principal Investigator:

Isak Isakov, M.D.

Jamaica Hospital Medical Center

More Information

No publications provided

Responsible Party:	Department of Psychiatry Research Division ( Isak Isakov, MD )
Study ID Numbers:	JH-PSY-Aripiprazole/Schiz/OCD
Study First Received:	September 7, 2006
Last Updated:	January 21, 2009
ClinicalTrials.gov Identifier:	NCT00374348 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Jamaica Hospital Medical Center:

Schizophrenia with OCD
Schizophrenia with-comorbid symptoms of Obsessive Compulsive Disorder(OCD)

Study placed in the following topic categories:

Schizophrenia
Tranquilizing Agents
Anxiety Disorders
Mental Disorders
Psychotropic Drugs
Central Nervous System Depressants

Psychotic Disorders
Aripiprazole
Antipsychotic Agents
Schizophrenia and Disorders with Psychotic Features
Obsessive-Compulsive Disorder

Additional relevant MeSH terms:

Disease
Tranquilizing Agents
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Pharmacologic Actions
Schizophrenia

Pathologic Processes
Anxiety Disorders
Mental Disorders
Therapeutic Uses
Aripiprazole
Central Nervous System Agents
Obsessive-Compulsive Disorder
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on May 07, 2009