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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:
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

September 7, 2006
September 15, 2011
March 2005
May 2008   (final data collection date for primary outcome measure)
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 ]
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
Complete list of historical versions of study NCT00374348 on ClinicalTrials.gov Archive Site
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 ]
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
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Schizophrenia OCD
  • Obsessive Compulsive Disorder
Drug: Aripiprazole
Abilify, 5mg; 10mg; 15mg; 20mg; 30mg
Other Name: Abilify
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
May 2008
May 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00374348
JH-PSY-Aripiprazole/Schiz/OCD
Not Provided
Isak Isakov, MD, Department of Psychiatry Research Division
Jamaica Hospital Medical Center
  • Bristol-Myers Squibb
  • Department of Psychiatry, Jamaica Hospital Medical Center
  • Research Division
Principal Investigator: Isak Isakov, M.D. Jamaica Hospital Medical Center
Jamaica Hospital Medical Center
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP