Study of Escitalopram in the Treatment of Specific Phobia

July 19, 2005 updated by: Connor, Kathryn M., M.D.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

12

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Dept of Psychiatry and Behvaioral Science, Duke Unviersity Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Response based on CGI-I category

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Connor, Kathryn M., M.D.

Collaborators

Forest Laboratories

Investigators

  • Principal Investigator: Kathryn M. Connor, M.D., Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Study Completion

September 1, 2004

Study Registration Dates

First Submitted

July 13, 2005

First Submitted That Met QC Criteria

July 19, 2005

First Posted (ESTIMATE)

July 21, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

July 21, 2005

Last Update Submitted That Met QC Criteria

July 19, 2005

Last Verified

July 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3990-02-9

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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