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

This study has been completed.
Sponsor:
Information provided by:
Northern California Institute of Research and Education
ClinicalTrials.gov Identifier:
NCT01024140
First received: December 1, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
  Purpose

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 Intervention
Chronic Posttraumatic Stress Disorder
 Drug: Escitalopram

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Trial of Escitalopram Treatment for Male Subjects With Posttraumatic Stress Disorder

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Northern California Institute of Research and Education:

Primary Outcome Measures:
  • The Clinician Administered PTSD Scale [ Time Frame: Administered at baseline (prior to treatment) and week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PTSD Checklist [ Time Frame: Each Visit: Week 0, 2, 4, 6, 8, & 12 ] [ Designated as safety issue: No ]
  • Beck Depression Inventory [ Time Frame: Each Visit: Week 0, 2, 4, 6, 8, & 12 ] [ Designated as safety issue: No ]
  • Profile of Mood State [ Time Frame: Each Visit: Week 0, 2, 4, 6, 8, & 12 ] [ Designated as safety issue: No ]
  • Social Adjustment Scale [ Time Frame: Initial, Mid-Trial and Final Assessments ] [ Designated as safety issue: No ]
  • Quality of Life Inventory [ Time Frame: Initial, Mid-Trial and Final Assessments ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: February 2003
Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01024140

Sponsors and Collaborators
Northern California Institute of Research and Education
Investigators
Principal Investigator: Thomas C Neylan, MD UCSF / VAMC / NCIRE
  More Information

No publications provided

Responsible Party: Thomas C. Neylan, M.D., UCSF / VAMC / NCIRE
ClinicalTrials.gov Identifier: NCT01024140     History of Changes
Other Study ID Numbers: NEY-608
Study First Received: December 1, 2009
Last Updated: December 1, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Northern California Institute of Research and Education:
Posttraumatic Stress Disorder
Escitalopram
Efficacy

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on May 22, 2013