Study of Escitalopram in the Treatment of Specific Phobia

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Escitalopram

About this trial

This is an interventional treatment trial for Phobic Disorders focused on measuring specific phobia, anxiety, SSRI, clinical trial, escitalopram

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Dept of Psychiatry and Behvaioral Science, Duke Unviersity Medical Center

Outcomes

Primary Outcome Measures

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

Response based on CGI-I category

Full Information

NCT ID

NCT00121069

First Posted

July 13, 2005

Last Updated

July 19, 2005

Sponsor

Connor, Kathryn M., M.D.

Collaborators

Forest Laboratories

1. Study Identification

Unique Protocol Identification Number

NCT00121069

Brief Title

Study of Escitalopram in the Treatment of Specific Phobia

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2005

Overall Recruitment Status

Completed

Study Start Date

September 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

September 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Connor, Kathryn M., M.D.

Collaborators

Forest Laboratories

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

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

Phobic Disorders

Keywords

specific phobia, anxiety, SSRI, clinical trial, escitalopram

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

12 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Escitalopram

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Response based on CGI-I category

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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kathryn M. Connor, M.D.

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dept of Psychiatry and Behvaioral Science, Duke Unviersity Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Phobic Disorders

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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