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
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||Phase|
|Chronic Posttraumatic Stress Disorder||Drug: Escitalopram||Not Applicable|
|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|
|Actual Primary Completion Date :||December 2004|
|Actual 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01024140
|Principal Investigator:||Thomas C Neylan, MD||UCSF / VAMC / NCIRE|