Open Trial of Escitalopram Treatment for Male Subjects With Posttraumatic Stress Disorder
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Open Trial of Escitalopram Treatment for Male Subjects With Posttraumatic Stress Disorder|
- The Clinician Administered PTSD Scale [ Time Frame: Administered at baseline (prior to treatment) and week 12 ]
- 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 ]
|Study Start Date:||February 2003|
|Study Completion Date:||December 2004|
|Primary Completion Date:||December 2004 (Final data collection date for primary outcome measure)|
Flexible dose (5-20mg/day) of escitalopram monotherapy.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01024140
|Principal Investigator:||Thomas C Neylan, MD||UCSF / VAMC / NCIRE|