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

NCT ID: NCT01024140

Last Updated: 2009-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2004-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Posttraumatic Stress Disorder

Keywords

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Posttraumatic Stress Disorder Escitalopram Efficacy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Escitalopram

Flexible dose (5-20mg/day) of escitalopram monotherapy.

Group Type EXPERIMENTAL

Escitalopram

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Lexapro

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Northern California Institute of Research and Education

OTHER

Sponsor Role lead

Responsible Party

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UCSF / VAMC / NCIRE

Principal Investigators

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Thomas C Neylan, MD

Role: PRINCIPAL_INVESTIGATOR

UCSF / VAMC / NCIRE

Other Identifiers

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NEY-608

Identifier Type: -

Identifier Source: org_study_id