Study of Escitalopram in the Treatment of Specific Phobia - Tabular View

Tracking Information

First Received Date ^ICMJE

July 13, 2005

Last Updated Date

July 19, 2005

Start Date ^ICMJE

September 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Response based on a criterion of 50% or greater reduction in the Marks Main Phobia Questionnaire and Marks Fear Questionnaire from baseline

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00121069 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Response based on CGI-I category

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Study of Escitalopram in the Treatment of Specific Phobia

Official Title ^ICMJE

Placebo-Controlled Pilot Study of Escitalopram in the Treatment of Specific Phobia

Brief Summary

This pilot study is designed to assess the efficacy of escitalopram in the treatment of specific phobia in adult outpatients.

Detailed Description

This double-blind placebo-controlled pilot trial study is designed to assess the efficacy of 12 weeks of escitalopram vs. placebo in the treatment of specific phobia in adult outpatients. It is hypothesized that escitalopram is safe and effective in the treatment of specific phobia.

Study Phase

Phase II, Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Phobic Disorders

Intervention ^ICMJE

Drug: Escitalopram

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Adults 18-65 years of age
DSM-IV criteria for specific phobia according to the MINI
For women of childbearing potential, a negative serum pregnancy test at screening
Written informed consent

Exclusion Criteria:

Any current primary DSM-IV diagnosis other than specific phobia
History of DSM-IV substance abuse or dependence within the last months
Lifetime history of bipolar I disorder, schizophrenia or other psychotic disorder, mental retardation, or other pervasive developmental disorder or cognitive disorder due to a general medical condition
Suicide risk or serious suicide attempt within the last year
Clinically significant laboratory or EKG abnormality or unstable medical condition
For women of childbearing potential, unwillingness to use an acceptable form of contraception during the study
Subjects needing concurrent use of psychotropic medications

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00121069

Responsible Party

Study ID Numbers ^ICMJE

3990-02-9

Study Sponsor ^ICMJE

Connor, Kathryn M., M.D.

Collaborators ^ICMJE

Forest Laboratories

Investigators ^ICMJE

Principal Investigator:

Kathryn M. Connor, M.D.

Duke University

Information Provided By

Connor, Kathryn M., M.D.

Verification Date

July 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP