NCT00121069

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2002

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 21, 2005

Completed
Last Updated

July 21, 2005

Status Verified

July 1, 2005

First QC Date

July 13, 2005

Last Update Submit

July 19, 2005

Conditions

Phobic Disorders

Keywords

specific phobiaanxietySSRIclinical trialescitalopram

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • Response based on CGI-I category

Interventions

EscitalopramDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Psychiatry and Behvaioral Science, Duke Unviersity Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Phobic DisordersPhobia, SpecificAnxiety Disorders

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Kathryn M. Connor, M.D.

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDIV

Study Record Dates

First Submitted

July 13, 2005

First Posted

July 21, 2005

Study Start

September 1, 2002

Study Completion

September 1, 2004

Last Updated

July 21, 2005

Record last verified: 2005-07

Locations

US(1)