ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12609000091202

Ethics application status

Approved

Date submitted

18/12/2008

Date registered

10/02/2009

Date last updated

10/02/2009

Type of registration

Retrospectively registered

Titles & IDs

Public title

The use of tiagabine and gabapentin in the treatment of social anxiety disorder in 8 patients

Scientific title

Gabapentin and tiagabine for treatment of social anxiety disorder in 8 patients in a random double blind crossover study with outcome measured as changes in the Leibowitz Social Anxiety Scale

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Subjects with social anxiety disorder

Condition category

Condition code

Mental Health

Anxiety

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Each subject was titrated to either 1800 mg gabapentin oral tablets daily or 2400 mg tiagabine oral tablets daily by mouth and stayed at that dosage for 4 weeks before being washed out for 2 weeks and receiving whichever medication they had not initially received.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

This study was a randomized double blind crossover study so that each subject was its own control

Control group

Active

Outcomes

Primary outcome [1]

Liebowitz Social Anxiety Scale: social anxiety

Timepoint [1]

Measured at 2 weeks, 4 weeks, 8 weeks, 10 weeks, 14 weeks, and 16 weeks after randomization

Secondary outcome [1]

Clinical Global impression scale: severity of illness and global functioning

Timepoint [1]

Measured at 2 weeks, 4 weeks, 8 weeks, 10 weeks, 14 weeks, and 16 weeks after randomization

Eligibility

Key inclusion criteria

diagnosis of social anxiety disorder by DSM-IV criterial and a Liebowitz Socail Anxiety Scale greater than 30.

Minimum age

18 Years

Maximum age

65 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Other Axis I psychiatric disorders, major medical illnesses, taking medications that interacted with the study drugs, actively using alcohol or illegal drugs, were pregnant, planning to become pregnant, or breastfeeding

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation concealment was done by a research coordinator who had no contact with subjects. The research coordinator put the study medication in a sealed opaque envelope for the investigator who did not know the contents of the envelope for distribution to the subject.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomization by using a randomization table from a statistics book

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Crossover

Other design features

Phase

Phase 2 / Phase 3

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

20/05/2003

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

United States of America

State/province [1]

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Norfolk Foundation

Address [1]

1 Commercial Place
Norfolk VA 23501

Country [1]

United States of America

Primary sponsor type

Individual

Name

Maria Urbano, M.D.

Address

Dept. of Psychiatry
Eastern Virginia Medical School
825 Fairfax Ave.
Norfolk VA
United States 23507

Country

United States of America

Secondary sponsor category [1]

Individual

Name [1]

David R. Spiegel, M.D.

Address [1]

Dept. of Psychiatry
Eastern Virginia Medical School
825 Fairfax Ave.
Norfolk VA
United States 23507

Country [1]

United States of America

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Eastern Virginia Medical School Institutional Review Board

Ethics committee address [1]

Eastern Virginia Medical School
P.O. Box 1980
Norfolk VA 23510

Ethics committee country [1]

United States of America

Date submitted for ethics approval [1]

Approval date [1]

24/08/2006

Ethics approval number [1]

05-06-FB-0140

Summary

Brief summary

Social Anxiety Disorder creates stress and significant disability for patients.  Common treatments like selective serotonin reuptake inhibitors and benzodiazepines have undesirable side effects like sexual dysfunction or the potential for drug abuse/ dependence.  The objective of the study was to see if alternative medications - tiagabine and gabapentin - already shown to be effective in other anxiety disorders might be effective for social anxiety disorder too.  Subjects were selected to have social anxiety disorder by meeting the DSM-IV criteria and having a high score on the Liebowitz Social Anxiety Scale.  Subjects were chosen who were generally healthy and had no other psychiatric diagnoses.  They received a physical exam and lab work before starting the study.  Each individual received each medication at a steady dosage for 4 weeks after being slowly increased for two weeks.  The subjects took a Liebowitz Social Anxiety Scale and Clinical Global Impression Scale on each visit as well as reported efficacy of the medication (unknown to the patient or the investigator) and any side effects.  Eight patients completed the study.  Both medications were well tolerated with sedation and mild dizziness being the most common.  All subjects with severe social anxiety responded well to both medications with two subjects reaching remission of symptoms.  Gabapentin and tiagabine should be considered as effective alternate treatments for social anxiety disorder.

Trial website

Trial related presentations / publications

Gabapentin and Tiagabine for Social Anxiety Disorder:  A Randomized, Double Blind Crossover Study of 8 Adults
This paper has been submitted and accepted for publication in the Primary Care Companion of the Journal of Clinical Psychiatry.  It has not been assigned a publication date.

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Maria R. Urbano, M.D.

Address

Dept. of Psychiatry
Eastern Virginia Medical School
825 Fairfax Ave.
Norfolk VA United States of America
23507

Country

United States of America

Phone

1-757-446-5888

Fax

1-757-446-5918

urbanomr@evms.edu

Contact person for scientific queries

Name

Maria R. Urbano, M.D.

Address

Dept. of Psychiatry
EasternVirginia Medical School
825 Fairfax Ave.
Norfolk VA United States of America
23507

Country

United States of America

Phone

1-757-446-5888

Fax

1-757-446-5918

urbanomr@evms.edu

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically