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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
Sponsor:
Information provided by:
Northern California Institute of Research and Education

Study Description
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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.


Condition or disease Intervention/treatment Phase
Chronic Posttraumatic Stress Disorder Drug: Escitalopram Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Escitalopram
Flexible dose (5-20mg/day) of escitalopram monotherapy.
 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.
Other Name: Lexapro


Outcome Measures
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Primary Outcome Measures :
  1. The Clinician Administered PTSD Scale [ Time Frame: Administered at baseline (prior to treatment) and week 12 ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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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


Sponsors and Collaborators
Northern California Institute of Research and Education
Investigators
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Principal Investigator: Thomas C Neylan, MD UCSF / VAMC / NCIRE
More Information
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Responsible Party: Thomas C. Neylan, M.D., UCSF / VAMC / NCIRE
ClinicalTrials.gov Identifier: NCT01024140     History of Changes
Other Study ID Numbers: NEY-608
First Posted: December 2, 2009    Key Record Dates
Last Update Posted: December 2, 2009
Last Verified: December 2009
Keywords provided by Northern California Institute of Research and Education:
Posttraumatic Stress Disorder
Escitalopram
Efficacy
Additional relevant MeSH terms:
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Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders
Dexetimide
Citalopram
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
 Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents