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Trial record 13 of 536 for:    ESCITALOPRAM AND Disorders

Open Trial of Escitalopram Treatment for Male Subjects With Posttraumatic Stress Disorder

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ClinicalTrials.gov Identifier: NCT01024140
Recruitment Status : Completed
First Posted : December 2, 2009
Last Update Posted : December 2, 2009
Sponsor:
Information provided by:
Northern California Institute of Research and Education

Tracking Information
First Submitted Date  ICMJE December 1, 2009
First Posted Date  ICMJE December 2, 2009
Last Update Posted Date December 2, 2009
Study Start Date  ICMJE February 2003
Actual Primary Completion Date December 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2009)
The Clinician Administered PTSD Scale [ Time Frame: Administered at baseline (prior to treatment) and week 12 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2009)
  • PTSD Checklist [ Time Frame: Each Visit: Week 0, 2, 4, 6, 8, & 12 ]
  • Beck Depression Inventory [ Time Frame: Each Visit: Week 0, 2, 4, 6, 8, & 12 ]
  • Profile of Mood State [ Time Frame: Each Visit: Week 0, 2, 4, 6, 8, & 12 ]
  • Social Adjustment Scale [ Time Frame: Initial, Mid-Trial and Final Assessments ]
  • Quality of Life Inventory [ Time Frame: Initial, Mid-Trial and Final Assessments ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open Trial of Escitalopram Treatment for Male Subjects With Posttraumatic Stress Disorder
Official Title  ICMJE Open Trial of Escitalopram Treatment for Male Subjects With Posttraumatic Stress Disorder
Brief Summary

The primary aim of this pilot study is to test the efficacy of the selective serotonin re-uptake inhibitor, Escitalopram, in the treatment of posttraumatic stress disorder (PTSD) in an open clinical trial.

A secondary aim is to determine whether treatment with escitalopram increases plasma allopregnanolone levels in patients with PTSD and if increases in allopregnanolone levels are correlated with treatment efficacy.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Posttraumatic Stress Disorder
Intervention  ICMJE Drug: Escitalopram
Subjects were started on 5mg escitalopram. Medication was increased as tolerated in weekly 2.5, 5 or 10 mg increments, until a maximally tolerated dosage or a clinical response was achieved. The final dosage ranged from 5 to 20 mg/day.
Other Name: Lexapro
Study Arms  ICMJE Experimental: Escitalopram
Flexible dose (5-20mg/day) of escitalopram monotherapy.
Intervention: Drug: Escitalopram
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 1, 2009)
16
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2004
Actual Primary Completion Date December 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Current DSM-IV TR PTSD and a score > 40 on the CAPS, as a result of a traumatic event that occurred at least 6 months prior to evaluation.

Exclusion Criteria:

  • Lifetime history of bipolar or any psychiatric disorder with psychotic features.
  • Prominent suicidal or homicidal ideation.
  • History of alcohol abuse/dependence within the past 3 months.
  • History of drug abuse/dependence within the past 6 months.
  • Subjects who plan to start a new form of psychotherapy during the protocol.
  • History of sleep apnea, neurological disorder and/or current systemic illness affecting central nervous system function.
  • History of myocardial infarction in the past year.
  • Subjects on antipsychotic medications, systemic steroid medication, antidepressants, mood stabilizers, antianxiety medication, or benzodiazepines within the past 2 weeks.
  • Use of Citalopram or Escitalopram within the past 6 months.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01024140
Other Study ID Numbers  ICMJE NEY-608
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Thomas C. Neylan, M.D., UCSF / VAMC / NCIRE
Study Sponsor  ICMJE Northern California Institute of Research and Education
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Thomas C Neylan, MD UCSF / VAMC / NCIRE
PRS Account Northern California Institute of Research and Education
Verification Date December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP