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Trial record 77 of 559 for:    ESCITALOPRAM AND Disorders

Prevention of Post Traumatic Stress Disorder by Early Treatment

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.
 
ClinicalTrials.gov Identifier: NCT00146900
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : February 19, 2016
Sponsor:
Information provided by (Responsible Party):
Aria Shalev, Hadassah Medical Organization

Tracking Information
First Submitted Date  ICMJE September 4, 2005
First Posted Date  ICMJE September 7, 2005
Last Update Posted Date February 19, 2016
Study Start Date  ICMJE August 2004
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2007)
Post-traumatic Stress Disorder (chronic) by CAPS scores. [ Time Frame: Four months, seven months, 14 moths, two years ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 4, 2005)
Post-traumatic Stress Disorder (chronic) by CAPS scores.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2007)
  • Symptoms of post-traumatic Stress Disorder per PSS-SR (questionnaire) and CAPS (structured interview) [ Time Frame: Four months, seven months, 14 moths, two years ]
  • Symptoms of depression as per the Beck Depression Inventory (BDI) [ Time Frame: Four months, seven months, 14 moths, two years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2005)
  • Post-traumatic Stress Disorder Symptoms per PSS-SR adn CAPS
  • Symptoms of depression be BDI
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention of Post Traumatic Stress Disorder by Early Treatment
Official Title  ICMJE Prevention of Post Traumatic Stress Disorder by Early Treatment
Brief Summary To prospectively evaluate the effect of early treatment (cognitive therapy (CT), cognitive-behavioral therapy (CBT) and escitalopram (SSRI) in preventing the occurrence of post-traumatic stress disorder in recent survivors of traumatic events.
Detailed Description Consecutive civilian trauma survivors will be contacted, by phone, within five days of admission to Hadassah University Hospital in Jerusalem and asked about their early psychological responses to the event. A short telephone interview will be administered to consenting subjects, to evaluate the presence of acute stress disorder (ASD). Subjects with ASD (full or partial) and those who so desire will be invited to clinical assessment, which will take place within the next two weeks. Survivors with significant symptoms of post-traumatic stress disorder will be randomized to five arms of twelve-week long treatment: CBT, CT, SSRI/placebo and waiting list (WL) and start treatment immediately. Subjects will be allowed to decline one form of therapy. WL subjects will start therapy 12 weeks later. All subjects who had clinical interview will be interviewed again at four and seven months - and 14 months following trauma (phone interview).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Post-traumatic Stress Disorder
Intervention  ICMJE
  • Procedure: Cognitive Behavioral Therapy
    12 weekly 1.5 hours weekly session of cognitive behavioral therapy (Prolonged Exposure)
  • Procedure: Cognitive Therapy
    12 weekly 1.5 hours weekly session of cognitive therapy without exposure
  • Drug: Escitalopram
    Twelve weeks of treatment with Escitalopram at Max. daily dose of 20mg
    Other Name: SSRI
  • Other: Placebo
    Twelve weeks of treatment with placebo pills resembling the original Escitalopram 10mg tablets but containing no active substance
Study Arms  ICMJE
  • Experimental: Prolonged Exposure (CBT)
    Twelve 1.5 hours weekly sessions of Prolonged Exposure cognitive behavioral therapy
    Intervention: Procedure: Cognitive Behavioral Therapy
  • Active Comparator: Cognitive Therapy
    Twelve 1.5 hours weekly sessions of Cognitive Therapy without exposure to traumatic reminders.
    Intervention: Procedure: Cognitive Therapy
  • Experimental: SSRI (escitalopram)
    Twenty milligrams daily of escitalopram (blinded capsules)
    Intervention: Drug: Escitalopram
  • Placebo Comparator: Placebo
    Two concealed placebo pills resembling 10mg escitalopram tablets
    Intervention: Other: Placebo
  • No Intervention: Waiting List
    Twelve weeks of waiting list no intervention group
Publications *

*   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: February 19, 2014)
298
Original Enrollment  ICMJE
 (submitted: September 4, 2005)
300
Actual Study Completion Date  ICMJE January 2008
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adults survivors of traumatic events

Exclusion Criteria:

  • Traumatic brain injury
  • Lifetime psychosis
  • Life time (prior) PTSD
  • Medical conditions forbidding SSRIs
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00146900
Other Study ID Numbers  ICMJE 21-27.06.03-HMO-CTIL
MH-
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Aria Shalev, Hadassah Medical Organization
Study Sponsor  ICMJE Hadassah Medical Organization
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Arieh Y Shalev, M.D. Hadassah Medical Organization
Study Director: Yossi Israeli - Shalev, M.A. Hadassah Medical Organization
PRS Account Hadassah Medical Organization
Verification Date February 2016

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