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An Open Label, Double-blind Discontinuation Study of Quetiapine Extended Release(XR)

Primary Purpose

Social Anxiety Disorder

Status

Terminated

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Quetiapine XR

Placebo

About this trial

This is an interventional prevention trial for Social Anxiety Disorder focused on measuring Social Anxiety Disorder, Quetiapine XR, Prevention, tolerability

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adults 18-65 years of age
A primary diagnosis of SAD,using Diagnostic Standard Manual IV(DSM-IV) criteria
Minimum CGI severity score of 4 and minimum Brief Social Phobia Scale (BSPS) score of 20 at baseline
Written informed consent
A negative serum pregnancy test for women of childbearing potential.

Exclusion Criteria:

Current DSM-IV diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, mental retardation or other pervasive developmental disorder, or cognitive disorder due to a general medical condition
Any current primary anxiety disorder other than SAD or current primary depression
History of substance abuse or dependence within the last 6 months
Suicide risk or serious suicide attempt within the last year
Clinically significant medical condition or laboratory abnormality
Women of childbearing potential who are unwilling to practice an acceptable method of contraception
Subjects needing concurrent use of psychotropic medications
History of hypersensitivity to quetiapine
History of cataracts.

Sites / Locations

Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Quetiapine XR 50mg-400mg per day

Placebo

Outcomes

Primary Outcome Measures

Kaplan Meier survival of Clinical Global Impression of Improvement (CGI-I)

Secondary Outcome Measures

Percentage of CGI-I, BSPS, SPIN

Full Information

NCT ID

NCT00606541

First Posted

January 22, 2008

Last Updated

July 31, 2014

Sponsor

Duke University

1. Study Identification

Unique Protocol Identification Number

NCT00606541

Brief Title

An Open Label, Double-blind Discontinuation Study of Quetiapine Extended Release(XR)

Official Title

An Open Label, Double-blind Discontinuation Study of Quetiapine (Extended Release) XR in Social Anxiety Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

December 2012

Overall Recruitment Status

Terminated

Why Stopped

The study was terminated by the sponsor due to budgetary issues

Study Start Date

January 2008 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Purpose of Study: To examine 1) the short and long-term effectiveness and tolerability of quetiapine (extended release) XR for the treatment of social anxiety disorder (SAD); and 2) continuation effects of quetiapine XR in preventing SAD relapse.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Social Anxiety Disorder

Keywords

Social Anxiety Disorder, Quetiapine XR, Prevention, tolerability

7. Study Design

Primary Purpose

Prevention

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

55 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Quetiapine XR 50mg-400mg per day

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

Quetiapine XR

Other Intervention Name(s)

Seroquel XR

Intervention Description

This is an investigator-initiated, single site study, consisting of two phases: 1) 8-week, open label treatment with quetiapine XR (50-400 mg/day) in subjects (n=55 in order to randomize 20 into each of the quetiapine XR and PBO arms in the 2nd phase of the study) with SAD; and 2) in those who demonstrate at least minimal improvement (i.e. CGI≤3), 12-weeks randomized, double-blind treatment with either quetiapine XR or placebo (PBO).

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Kaplan Meier survival of Clinical Global Impression of Improvement (CGI-I)

Time Frame

20 weeks

Secondary Outcome Measure Information:

Title

Percentage of CGI-I, BSPS, SPIN

Time Frame

20 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adults 18-65 years of age A primary diagnosis of SAD,using Diagnostic Standard Manual IV(DSM-IV) criteria Minimum CGI severity score of 4 and minimum Brief Social Phobia Scale (BSPS) score of 20 at baseline Written informed consent A negative serum pregnancy test for women of childbearing potential. Exclusion Criteria: Current DSM-IV diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, mental retardation or other pervasive developmental disorder, or cognitive disorder due to a general medical condition Any current primary anxiety disorder other than SAD or current primary depression History of substance abuse or dependence within the last 6 months Suicide risk or serious suicide attempt within the last year Clinically significant medical condition or laboratory abnormality Women of childbearing potential who are unwilling to practice an acceptable method of contraception Subjects needing concurrent use of psychotropic medications History of hypersensitivity to quetiapine History of cataracts.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wei Zhang, MD

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

12. IPD Sharing Statement

Learn more about this trial

An Open Label, Double-blind Discontinuation Study of Quetiapine Extended Release(XR)

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