Schizoaffective Disorder, Schizophrenia, Social Anxiety Disorder
Conditions
Keywords
Schizophrenia, Schizoaffective Disorder, Social Anxiety Disorder
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.
Interventions
DRUGAripiprazole
Sponsors
Bristol-Myers Squibb
University of Medicine and Dentistry of New Jersey
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liebowitz Social Anxiety Scale- Change from Baseline to Final Visit | — |
| Sheehan Disability Scale- Change from Baseline to Final Visit | — |
| Lehman Quality of Life Interview- Change from Baseline to Final Visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Arizona sexual dysfunction scale- Change from Baseline to Final Visit | — |
| COSAPSQ -Change from Baseline to Final Visit | — |
| Instrumental Activities of Daily Living-Change from Baseline to Final Visit | — |
| PANSS- Change from Baseline to Final Visit | — |
| CAGE -Change from Baseline to Final Visit | — |
| HAM-D-Change from Baseline to Final Visit | — |
| Clinical Global Impression scales [CGI]and [CGI-C]- change from Baseline to Final Visit. | — |
| Ultimate game paradigm as a measure of social cohesion- Change from Baseline to Final Visit | — |
Countries
United States
Outcome results
None listed