Back to resultsOpen Trial of Escitalopram Treatment for Male Subjects With Posttraumatic Stress Disorder
Primary Purpose
Chronic Posttraumatic Stress Disorder
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Escitalopram
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Posttraumatic Stress Disorder focused on measuring Posttraumatic Stress Disorder, Escitalopram, Efficacy
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Escitalopram
Arm Description
Flexible dose (5-20mg/day) of escitalopram monotherapy.
Outcomes
Primary Outcome Measures
The Clinician Administered PTSD Scale
Secondary Outcome Measures
PTSD Checklist
Beck Depression Inventory
Profile of Mood State
Social Adjustment Scale
Quality of Life Inventory
Full Information
NCT ID
NCT01024140
First Posted
December 1, 2009
Last Updated
December 1, 2009
Sponsor
Northern California Institute of Research and Education
1. Study Identification
Unique Protocol Identification Number
NCT01024140
Brief Title
Open Trial of Escitalopram Treatment for Male Subjects With Posttraumatic Stress Disorder
Official Title
Open Trial of Escitalopram Treatment for Male Subjects With Posttraumatic Stress Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
December 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Northern California Institute of Research and Education
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Posttraumatic Stress Disorder
Keywords
Posttraumatic Stress Disorder, Escitalopram, Efficacy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Escitalopram
Arm Type
Experimental
Arm Description
Flexible dose (5-20mg/day) of escitalopram monotherapy.
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Other Intervention Name(s)
Lexapro
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Clinician Administered PTSD Scale
Time Frame
Administered at baseline (prior to treatment) and week 12
Secondary Outcome Measure Information:
Title
PTSD Checklist
Time Frame
Each Visit: Week 0, 2, 4, 6, 8, & 12
Title
Beck Depression Inventory
Time Frame
Each Visit: Week 0, 2, 4, 6, 8, & 12
Title
Profile of Mood State
Time Frame
Each Visit: Week 0, 2, 4, 6, 8, & 12
Title
Social Adjustment Scale
Time Frame
Initial, Mid-Trial and Final Assessments
Title
Quality of Life Inventory
Time Frame
Initial, Mid-Trial and Final Assessments
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas C Neylan, MD
Organizational Affiliation
UCSF / VAMC / NCIRE
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Open Trial of Escitalopram Treatment for Male Subjects With Posttraumatic Stress Disorder
We'll reach out to this number within 24 hrs