Clinical trial NCT00177008: Aripiprazole for the Treatment of Schizophrenia With Co-Morbid Social Anxiety
Official title: Aripiprazole for the Treatment of Schizophrenia With Co-Morbid Social Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Schizoaffective Disorder
Social Anxiety Disorder
Keywords: Schizophrenia
Schizoaffective Disorder
Social Anxiety Disorder
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2005-09-15
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will determine the efficacy of a medication switch to Aripiprazole for the treatment of schizophrenia or schizoaffective disorder in patients with moderate to high symptoms of social anxiety. Specifically the study will test the possibility that a medication switch to Aripiprazole reduces symptoms of social anxiety in this patient population.

Detailed description: Although research has shown that social anxiety is very common among patients suffering from schizophrenia or schizoaffective disorder, it is rarely diagnosed and treated in this patient population. This study will determine the efficacy of a medication switch to Aripiprazole for the treatment of schizophrenia in patients with moderate to high symptoms of social anxiety. Specifically the study will test the possibility that a medication switch to Aripiprazole reduces symptoms of social anxiety in this patient population. In addition, the study will test the possibility that Aripiprazole significantly improves social adjustment, quality of life and level of functioning in these patients. The study may also assess the ability of Aripiprazole to reduce sexual dysfunction.

Eligibility criteria: Inclusion Criteria

1. Patients meeting DSM IV diagnostic criteria for schizophrenia or schizoaffective disorder.
2. Patients presenting with comorbid social anxiety symptoms of moderate to high severity are eligible for participation in the study. Only patients with LSAS scores above 30\* qualify for the study.
3. Age 18-65
4. Gender: males or females
5. Females: non-pregnant, not of child-bearing potential; if of child-bearing age must be on contraceptive such as pill or shot (condom alone not sufficient)
6. Good general health

Exclusion Criteria:

1. Patient does not meet DSM IV diagnostic criteria for schizophrenia or schizoaffective disorder
2. Patient carries a diagnosis of dementia, degenerative CNS disorders, mental retardation, substance abuse or dependence other than nicotine dependence or alcohol abuse will be excluded from the study.
3. Patients with acute medical conditions are not eligible.
4. Patients allergic or otherwise intolerant or non-responsive to Aripiprazole
5. Patient with history of suicidal, homicidal or assaultive plans or attempts in the past 6 months.
6. Clinically significant EKG or lab abnormalities

Primary outcomes:
measure: Liebowitz Social Anxiety Scale- Change from Baseline to Final Visit
measure: Sheehan Disability Scale- Change from Baseline to Final Visit
measure: Lehman Quality of Life Interview- Change from Baseline to Final Visit
Secondary outcomes:
measure: Instrumental Activities of Daily Living-Change from Baseline to Final Visit
measure: Clinical Global Impression scales [CGI]and [CGI-C]- change from Baseline to Final Visit.
measure: Ultimate game paradigm as a measure of social cohesion- Change from Baseline to Final Visit
measure: Arizona sexual dysfunction scale- Change from Baseline to Final Visit
measure: COSAPSQ -Change from Baseline to Final Visit
measure: HAM-D-Change from Baseline to Final Visit
measure: PANSS- Change from Baseline to Final Visit
measure: CAGE -Change from Baseline to Final Visit
Other outcomes:
Locations:
city: Piscataway
country: United States
facility: Robert Wood Johnson Medical School - Psychiatry Dept.
state: New Jersey
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Theodore Petti, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: UMDNJ-RWJMS
name: Robert Stern, MD
role: STUDY_DIRECTOR
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