Study To Evaluate The Effects Of Gabitril™ In Patients Wi... | NCT00208741

Studies
Study To Evaluate The Effects Of Gabitril™ In Patients With Social Anxiety Disorder

NCT00208741

Sponsor

Emory University

Status

Completed

Last Update Posted

Nov 11, 2013Estimated

Enrollment

Phase

Phase 4

Conditions

Social Anxiety Disorder

Interventions

Gabitril

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

Nov 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2002

Primary Completion Date

Not provided

Completion Date

Nov 2003

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 21, 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

Nov 8, 2013

Last Update Posted Date

Nov 11, 2013Estimated

Name	Class
Cephalon	INDUSTRY

Description Module

Brief Summary

The main purpose of this study is to determine how safe and effective Gabitril is for outpatients with Social Anxiety Disorder (SAD).

Detailed Description

This study is being conducted at two sites in the United States. Approximately 50 patients, who are between the ages of 18 and 65 years old will be enrolled at Emory. This study consists of two parts. The first part consists of 12 weeks of open-label treatment with Gabitril. If the study doctor determines that the patients condition has improved and they have completed the initial 12 weeks of treatment they may be eligible for the second part of the study. This part is a 24-week double-blind treatment period with either Gabitril or placebo (inactive medication). There will also be a follow-up visit about 1 to 3 weeks after they have completed taking the study medication. Altogether study participation is expected to last approximately 37 weeks.

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
Gabitril	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Liebowitz Social Anxiety Scale (LSAS)
Clinical Global Impression-Change (CGI-C)

Secondary Outcomes

Measure	Description	Time Frame
Hamilton Anxiety Scale (HAM-A)
Social Phobia Inventory (SPIN)
Pittsburgh Sleep Quality Index (PSQI)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Primary diagnosis of SAD
CGI (S) ≥ 4 at screen
LSAS ≥ 50 at baseline
Covi Anxiety Scale score greater than the Raskin depression Scale total score at screen

Exclusion Criteria:

Non-responsive to adequate trials of two or more treatment medications, if previously treated for SAD.
HAM-D ≥15 or a score of >2 on Item 1 at baseline
Serious or unstable medical condition
Alcohol or substance use disorder within 6 months prior to study

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
Philip T Ninan, MD	Emory University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Emory University School of Medicine		Atlanta	Georgia	30329	United States
Hillside Hospital of the North Shore-Long Island Jewish Health System

Condition Browse Module

MeSH Terms

ID	Term
D000072861	Phobia, Social
D000092862	Psychological Well-Being

Ancestor Terms

ID	Term
D010698	Phobic Disorders
D001008	Anxiety Disorders
D001523	Mental Disorders
D010549	Personal Satisfaction

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000078308	Tiagabine

Ancestor Terms

ID	Term
D009557	Nipecotic Acids
D000147	Acids, Heterocyclic
D006571	Heterocyclic Compounds
D010880	Piperidines

Browse Leaves

Not provided

Browse Branches

Not provided