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
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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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 16 participants |
Allocation: | N/A |
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 |

Arm | Intervention/treatment |
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Experimental: Escitalopram
Flexible dose (5-20mg/day) of escitalopram monotherapy.
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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 |
- The Clinician Administered PTSD Scale [ Time Frame: Administered at baseline (prior to treatment) and week 12 ]
- PTSD Checklist [ Time Frame: Each Visit: Week 0, 2, 4, 6, 8, & 12 ]
- Beck Depression Inventory [ Time Frame: Each Visit: Week 0, 2, 4, 6, 8, & 12 ]
- Profile of Mood State [ Time Frame: Each Visit: Week 0, 2, 4, 6, 8, & 12 ]
- Social Adjustment Scale [ Time Frame: Initial, Mid-Trial and Final Assessments ]
- Quality of Life Inventory [ Time Frame: Initial, Mid-Trial and Final Assessments ]

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

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
Principal Investigator: | Thomas C Neylan, MD | UCSF / VAMC / NCIRE |
Responsible Party: | Thomas C. Neylan, M.D., UCSF / VAMC / NCIRE |
ClinicalTrials.gov Identifier: | NCT01024140 |
Other Study ID Numbers: |
NEY-608 |
First Posted: | December 2, 2009 Key Record Dates |
Last Update Posted: | December 2, 2009 |
Last Verified: | December 2009 |
Posttraumatic Stress Disorder Escitalopram Efficacy |
Disease Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Pathologic Processes Trauma and Stressor Related Disorders Mental Disorders 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 |