Open Trial of Escitalopram Treatment for Male Subjects With Posttraumatic Stress Disorder

NCT01024140 | Completed

• 1 other identifier: NEY-608
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Posttraumatic Stress Disorder

Keywords

Posttraumatic Stress Disorder; Escitalopram; Efficacy

Outcome Measures

Primary Outcomes (1)

• The Clinician Administered PTSD Scale

  Administered at baseline (prior to treatment) and week 12

Secondary Outcomes (5)

• 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

Study Arms (1)

Escitalopram

EXPERIMENTAL

Flexible dose (5-20mg/day) of escitalopram monotherapy.

Drug: Escitalopram

Interventions

Escitalopram DRUG

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.

Also known as: Lexapro

Escitalopram

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northern California Institute of Research and Education: lead

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Thomas C Neylan, MD

  UCSF / VAMC / NCIRE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 1, 2009
• First Posted: December 2, 2009
• Study Start: February 1, 2003
• Primary Completion: December 1, 2004
• Study Completion: December 1, 2004
• Last Updated: December 2, 2009

Record last verified: 2009-12