Aripiprazole for the Treatment of Schizophrenia With Co-Morbid Social Anxiety

University of Medicine and Dentistry of New Jersey

Status and phase: Completed; Phase 4

Conditions: Schizophrenia; Schizoaffective Disorder; Social Anxiety Disorder

Treatments: Drug: Aripiprazole

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00177008

4680

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)