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NCT00121069 Clinical Trial

Study of Escitalopram in the Treatment of Specific Phobia

Phobic Disorders Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00121069
Other study ID # 3990-02-9
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received July 13, 2005
Last updated July 19, 2005
Start date September 2002
Est. completion date September 2004

Study information
Verified date July 2005
Source Connor, Kathryn M., M.D.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date September 2004
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Escitalopram

Locations
Country Name City State
United States Dept of Psychiatry and Behvaioral Science, Duke Unviersity Medical Center Durham North Carolina

Sponsors (2)
Lead Sponsor Collaborator
Connor, Kathryn M., M.D. Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Response based on a criterion of 50% or greater reduction in the Marks Main Phobia Questionnaire and Marks Fear Questionnaire from baseline
Secondary Response based on CGI-I category
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