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

Chronic Posttraumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01024140
• Other study ID #: NEY-608
• Status: Completed
• Phase: N/A
• First received: December 1, 2009
• Last updated: December 1, 2009
• Start date: February 2003
• Est. completion date: December 2004

Study information

• Verified date: December 2009
• Source: Northern California Institute of Research and Education
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2004
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 60 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• Escitalopram
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Northern California Institute of Research and Education

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Clinician Administered PTSD Scale		Administered at baseline (prior to treatment) and week 12	No
Secondary	PTSD Checklist		Each Visit: Week 0, 2, 4, 6, 8, & 12	No
Secondary	Beck Depression Inventory		Each Visit: Week 0, 2, 4, 6, 8, & 12	No
Secondary	Profile of Mood State		Each Visit: Week 0, 2, 4, 6, 8, & 12	No
Secondary	Social Adjustment Scale		Initial, Mid-Trial and Final Assessments	No
Secondary	Quality of Life Inventory		Initial, Mid-Trial and Final Assessments	No