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Completed

NCT Number: NCT00177008

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Robert Wood Johnson Medical School - Psychiatry Dept.

Piscataway, New Jersey, 08854, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients meeting DSM IV diagnostic criteria for schizophrenia or schizoaffective disorder.
  • 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.
  • Age 18-65
  • Gender: males or females
  • 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)
  • Good general health

Exclusion criteria

  • Patient does not meet DSM IV diagnostic criteria for schizophrenia or schizoaffective disorder
  • 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.
  • Patients with acute medical conditions are not eligible.
  • Patients allergic or otherwise intolerant or non-responsive to Aripiprazole
  • Patient with history of suicidal, homicidal or assaultive plans or attempts in the past 6 months.
  • Clinically significant EKG or lab abnormalities

Treatment and study plan

Aripiprazole

Drug

Primary outcomes

  1. Liebowitz Social Anxiety Scale- Change from Baseline to Final Visit

  2. Sheehan Disability Scale- Change from Baseline to Final Visit

  3. Lehman Quality of Life Interview- Change from Baseline to Final Visit

Secondary outcomes

  1. Instrumental Activities of Daily Living-Change from Baseline to Final Visit

  2. Clinical Global Impression scales [CGI]and [CGI-C]- change from Baseline to Final Visit.

  3. Ultimate game paradigm as a measure of social cohesion- Change from Baseline to Final Visit

  4. Arizona sexual dysfunction scale- Change from Baseline to Final Visit

  5. COSAPSQ -Change from Baseline to Final Visit

  6. HAM-D-Change from Baseline to Final Visit

  7. PANSS- Change from Baseline to Final Visit

  8. CAGE -Change from Baseline to Final Visit

Sponsors and collaborators

Lead sponsor

University of Medicine and Dentistry of New Jersey

Other

Collaborators

  • Bristol-Myers Squibb

Registry information

Important dates

Study start
2004
Study completion
2007
First posted
Sep 15, 2005
Registry last updated
Jan 29, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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