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OpenTrials
Completed

NCT Number: NCT01024140

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

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.

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Key information

Conditions

Chronic Posttraumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

20 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Lexapro

Primary outcomes

  1. The Clinician Administered PTSD Scale

    Time frame: Administered at baseline (prior to treatment) and week 12

Secondary outcomes

  1. PTSD Checklist

    Time frame: Each Visit: Week 0, 2, 4, 6, 8, & 12

  2. Beck Depression Inventory

    Time frame: Each Visit: Week 0, 2, 4, 6, 8, & 12

  3. Profile of Mood State

    Time frame: Each Visit: Week 0, 2, 4, 6, 8, & 12

  4. Social Adjustment Scale

    Time frame: Initial, Mid-Trial and Final Assessments

  5. Quality of Life Inventory

    Time frame: Initial, Mid-Trial and Final Assessments

Sponsors and collaborators

Lead sponsor

Northern California Institute of Research and Education

Other

Registry information

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Dec 2, 2009
Registry last updated
Dec 2, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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