Aripiprazole in the Treatment of Patients With Schizophrenia and Symptoms of Obsessive Compulsive Disorder (OCD)
Information source: Jamaica Hospital Medical Center
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia OCD; Obsessive Compulsive Disorder
Intervention: Aripiprazole (Drug)
Phase: N/A
Status: Completed
Sponsored by: Jamaica Hospital Medical Center Official(s) and/or principal investigator(s): Isak Isakov, M.D., Principal Investigator, Affiliation: Jamaica Hospital Medical Center
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.
Clinical Details
Official title: "Aripiprazole in the Treatment of Patients With Schizophrenia and Symptoms of Obsessive Compulsive Disorder (OCD)".
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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: 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
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Jamaica Hospital Medical Center Department of Psychiatry, Jamaica, New York 11418, United States
Additional Information
Starting date: March 2005
Last updated: September 15, 2011
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