Study of Escitalopram in the Treatment of Specific Phobia

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by:
Connor, Kathryn M., M.D.
ClinicalTrials.gov Identifier:
NCT00121069
First received: July 13, 2005
Last updated: July 19, 2005
Last verified: July 2005
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov Identifier: NCT00121069     History of Changes
Other Study ID Numbers: 3990-02-9
Study First Received: July 13, 2005
Last Updated: July 19, 2005
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:
Phobic Disorders
Anxiety Disorders
Mental Disorders
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 14, 2014