Study of Escitalopram in the Treatment of Specific Phobia

This study has been completed.

First Received: July 13, 2005 Last Updated: July 19, 2005 History of Changes

Sponsor:	Connor, Kathryn M., M.D.
Collaborator:	Forest Laboratories
Information provided by:	Connor, Kathryn M., M.D.
ClinicalTrials.gov Identifier:	NCT00121069

Purpose

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

Condition	Intervention	Phase
Phobic Disorders	Drug: Escitalopram	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Placebo-Controlled Pilot Study of Escitalopram in the Treatment of Specific Phobia

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Phobias

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by Connor, Kathryn M., M.D.:

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

Estimated Enrollment:	12
Study Start Date:	September 2002
Estimated Study Completion Date:	September 2004

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00121069

Locations

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

Sponsors and Collaborators

Connor, Kathryn M., M.D.

Forest Laboratories

Investigators

Principal Investigator:

Kathryn M. Connor, M.D.

Duke University

More Information

No publications provided

Study ID Numbers:	3990-02-9
Study First Received:	July 13, 2005
Last Updated:	July 19, 2005
ClinicalTrials.gov Identifier:	NCT00121069 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Connor, Kathryn M., M.D.:

specific phobia
anxiety
SSRI
clinical trial
escitalopram

Additional relevant MeSH terms:

Parasympatholytics
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Cholinergic Agents
Mental Disorders
Therapeutic Uses
Dexetimide

Antidepressive Agents, Second-Generation
Antidepressive Agents
Phobic Disorders
Citalopram
Serotonin Uptake Inhibitors
Pharmacologic Actions
Muscarinic Antagonists
Serotonin Agents
Anxiety Disorders
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 22, 2009