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

NCT00374348 | Completed

• 1 other identifier: JH-PSY-Aripiprazole/Schiz/OCD
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia OCD; Obsessive Compulsive Disorder

Keywords

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

Outcome Measures

Primary Outcomes (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

  weekly

Secondary Outcomes (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

  weekly

Interventions

Aripiprazole DRUG

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

Also known as: Abilify

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jamaica Hospital Medical Center: lead
• Bristol-Myers Squibb: collaborator
• Department of Psychiatry, Jamaica Hospital Medical Center: collaborator
• Research Division: collaborator

Study Sites (1)

Jamaica Hospital Medical Center Department of Psychiatry

Jamaica, New York, 11418, United States

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Isak Isakov, M.D.

  Jamaica Hospital Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 7, 2006
• First Posted: September 11, 2006
• Study Start: March 1, 2005
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: September 16, 2011

Record last verified: 2009-01

Locations

US (1)