Open Trial of Escitalopram Treatment for Male Subjects With Posttraumatic Stress Disorder
|ClinicalTrials.gov Identifier: NCT01024140|
Recruitment Status : Completed
First Posted : December 2, 2009
Last Update Posted : December 2, 2009
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.
|Condition or disease||Intervention/treatment|
|Chronic Posttraumatic Stress Disorder||Drug: Escitalopram|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open Trial of Escitalopram Treatment for Male Subjects With Posttraumatic Stress Disorder|
|Study Start Date :||February 2003|
|Primary Completion Date :||December 2004|
|Study Completion Date :||December 2004|
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
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01024140
|Principal Investigator:||Thomas C Neylan, MD||UCSF / VAMC / NCIRE|