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

N

Northern California Institute of Research and Education (NCIRE)

Status

Completed

Conditions

Chronic Posttraumatic Stress Disorder

Treatments

Drug: Escitalopram

Study type

Interventional

Funder types

Other

Identifiers

NCT01024140
NEY-608

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

Male

Ages

20 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

16 participants in 1 patient group

Escitalopram
Experimental group
Description:
Flexible dose (5-20mg/day) of escitalopram monotherapy.
Treatment:
Drug: Escitalopram

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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