Aripiprazole for the Treatment of Schizophrenia With Co-M... | NCT00177008

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

NCT00177008

Sponsor

University of Medicine and Dentistry of New Jersey

Status

Completed

Last Update Posted

Jan 29, 2007Estimated

Enrollment

Phase

Phase 4

Conditions

Schizophrenia
Schizoaffective Disorder
Social Anxiety Disorder

Interventions

Aripiprazole

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Mar 2004

Primary Completion Date

Not provided

Completion Date

Jan 2007

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 15, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 25, 2007

Last Update Posted Date

Jan 29, 2007Estimated

Name	Class
Bristol-Myers Squibb	INDUSTRY

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Aripiprazole	Drug

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	Time Frame
Instrumental Activities of Daily Living-Change from Baseline to Final Visit
Clinical Global Impression scales [CGI]and [CGI-C]- change from Baseline to Final Visit.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Theodore Petti, MD, MPH	Rutgers, The State University of New Jersey	Principal Investigator
Robert Stern, MD	UMDNJ-RWJMS	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Robert Wood Johnson Medical School - Psychiatry Dept.		Piscataway	New Jersey	08854	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
8911225	Background	Kendler KS, Gallagher TJ, Abelson JM, Kessler RC. Lifetime prevalence, demographic risk factors, and diagnostic validity of nonaffective psychosis as assessed in a US community sample. The National Comorbidity Survey. Arch Gen Psychiatry. 1996 Nov;53(11):1022-31. doi: 10.1001/archpsyc.1996.01830110060007.
9501887	Background

ID	Term
D012559	Schizophrenia
D011618	Psychotic Disorders
D000072861	Phobia, Social

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders
D010698	Phobic Disorders
D001008	Anxiety Disorders

ID	Term
D010879	Piperazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D015363	Quinolones