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

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ClinicalTrials.gov Identifier: NCT00374348
Recruitment Status : Completed
First Posted : September 11, 2006
Last Update Posted : September 16, 2011
Sponsor:
Collaborators:
Bristol-Myers Squibb
Department of Psychiatry, Jamaica Hospital Medical Center
Research Division
Information provided by:
Jamaica Hospital Medical Center

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 Not Applicable

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  (Clinical Trial)
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 : March 2005
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Aripiprazole
    Abilify, 5mg; 10mg; 15mg; 20mg; 30mg
    Other Name: Abilify


Primary Outcome Measures :
  1. 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 :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: September 11, 2006    Key Record Dates
Last Update Posted: September 16, 2011
Last Verified: January 2009

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