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Study of Escitalopram in the Treatment of Specific Phobia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00121069
First Posted: July 21, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Forest Laboratories
Information provided by:
Connor, Kathryn M., M.D.
  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 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Placebo-Controlled Pilot Study of Escitalopram in the Treatment of Specific Phobia

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00121069     History of Changes
Other Study ID Numbers: 3990-02-9
First Submitted: July 13, 2005
First Posted: July 21, 2005
Last Update Posted: December 9, 2005
Last Verified: July 2005

Keywords provided by Connor, Kathryn M., M.D.:
specific phobia
anxiety
SSRI
clinical trial
escitalopram

Additional relevant MeSH terms:
Phobic Disorders
Anxiety Disorders
Mental Disorders
Citalopram
Dexetimide
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents