Chronic Posttraumatic Stress Disorder
Conditions
Keywords
Posttraumatic Stress Disorder, Escitalopram, Efficacy
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.
Interventions
DRUGEscitalopram
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.
Sponsors
Northern California Institute of Research and Education
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Clinician Administered PTSD Scale | Administered at baseline (prior to treatment) and week 12 |
Secondary
| Measure | Time frame |
|---|---|
| PTSD Checklist | Each Visit: Week 0, 2, 4, 6, 8, & 12 |
| Beck Depression Inventory | Each Visit: Week 0, 2, 4, 6, 8, & 12 |
| Profile of Mood State | Each Visit: Week 0, 2, 4, 6, 8, & 12 |
| Social Adjustment Scale | Initial, Mid-Trial and Final Assessments |
| Quality of Life Inventory | Initial, Mid-Trial and Final Assessments |
Outcome results
None listed