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Effects of Duloxetine on Fear Conditioning in Posttraumatic Stress Disorder (PTSD)

Primary Purpose

Posttraumatic Stress Disorder

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Duloxetine

About this trial

This is an interventional basic science trial for Posttraumatic Stress Disorder focused on measuring PTSD

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion criteria:

Patients with PTSD (age range 18-65 years) as determined by the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, non-patient version (First et al., 1996)
Willingness to participate in a naturalistic treatment study using duloxetine and in two fear conditioning tests, one at baseline and one at the end of the 8 weeks treatment study. We will include PTSD subjects on medications (possible medications include antidepressants, benzodiazepines, and neuroleptics) who have no or only partial treatment response or PTSD patients who are untreated. Treatment will be switched to duloxetine and the previous antidepressant medication will be discontinued.
PTSD subjects will have a minimum score of 50 on the Clinician-Administered PTSD Scale (CAPS; Blake et al, 1995).
Participants will be enrolled until the number of 20 subjects who complete the study is reached.
All subjects are required to be in a medically stable condition as determined by a thorough physical examination, including ECG, blood work and urine analysis.
No vulnerable subjects will be recruited for this study.

Exclusion criteria:

comorbid diagnosis of bipolar illness, schizophrenia or other psychotic disorders or presence of psychotic symptoms
acute or chronic suicidality
acute or chronic unstable medical conditions (including severely impaired hepatic function as indicated with abnormal PT and PTT, abnormal CBC, and liver enzymes more than 50% above the upper normal range, not well controlled blood pressure)
current diagnosis of substance abuse or dependence
unsuccessful treatment history with duloxetine, known hypersensitivity to duloxetine or any of its inactive ingredients
administration of any investigational drug up to 90 days before entry into the study
intake of monoamino oxides inhibitors up to 90 days before entry into the study or during the study
subjects with a positive screen for drugs of abuse
no startle or skin conductance response, or excessively high startle response to the startle probe (100 dB acoustic stimuli) during the pretest
patients with uncontrolled narrow-angle glaucoma
Pregnant as indicated by urine pregnancy test or unwillingness to prevent conception during the course of the study.

Sites / Locations

VA Connecticut Healthcare System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PTSD

Arm Description

Duloxetine

Outcomes

Primary Outcome Measures

Anxiolytic and antidepressant effects of duloxetine in patients with chronic PTSD

Secondary Outcome Measures

Full Information

NCT ID

NCT00763178

First Posted

December 25, 2007

Last Updated

April 21, 2015

Sponsor

Yale University

Collaborators

VA Connecticut Healthcare System

1. Study Identification

Unique Protocol Identification Number

NCT00763178

Brief Title

Effects of Duloxetine on Fear Conditioning in Posttraumatic Stress Disorder (PTSD)

Official Title

Effects of Duloxetine on Fear Conditioning in PTSD

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Completed

Study Start Date

February 2007 (undefined)

Primary Completion Date

April 2009 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

Collaborators

VA Connecticut Healthcare System

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Chronic posttraumatic stress disorder (PTSD) is a debilitating disorder and treatment response to pharmacological interventions has been modest for these patients. Chronic elevated anxiety and associated psychophysiological parameters including increased heart rate and alterations in skin conductance are key symptoms of chronic PTSD. Selective serotonin reuptake inhibitors (SRIs) are considered treatment of first choice for these patients, however a substantial portion of patients treated with SRIs do not respond sufficiently. Therefore, there is a need to establish novel and effective treatment strategies for these patients. Recently, duloxetine has received considerable attention since it was shown in multiple controlled trials to be an effective treatment for people with major depressive disorder (MDD), a condition which is often co-morbid with PTSD. In chronic PTSD, the psychophysiological responses at baseline and in response to treatment with duloxetine have been inadequately studied and may provide novel insight into antidepressant and anxiolytic mechanisms of this compound. Primary Aim 1: Evaluate the anxiolytic and antidepressant effects of duloxetine in patients with chronic PTSD. Secondary Aim 2: Evaluate the effects of duloxetine on fear conditioned psychophysiological responses (including startle eyeblink, skin conductance, and cardiovascular inter-beat interval) at baseline and after 8 weeks of naturalistic treatment in chronic PTSD patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Posttraumatic Stress Disorder

Keywords

PTSD

7. Study Design

Primary Purpose

Basic Science

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PTSD

Arm Type

Experimental

Arm Description

Duloxetine

Intervention Type

Drug

Intervention Name(s)

Duloxetine

Other Intervention Name(s)

Cymbalta

Intervention Description

Dosage given according to the following schedule: Week 1: 30mg QD, Week 2: 60mg QD, Week 3: 60mg QD, Week 4-6: Flexible dosing according to clinical situation, dose range between 60-120mg QD, Weeks 7 + 8: fixed dose

Primary Outcome Measure Information:

Title

Anxiolytic and antidepressant effects of duloxetine in patients with chronic PTSD

Time Frame

8 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Patients with PTSD (age range 18-65 years) as determined by the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, non-patient version (First et al., 1996) Willingness to participate in a naturalistic treatment study using duloxetine and in two fear conditioning tests, one at baseline and one at the end of the 8 weeks treatment study. We will include PTSD subjects on medications (possible medications include antidepressants, benzodiazepines, and neuroleptics) who have no or only partial treatment response or PTSD patients who are untreated. Treatment will be switched to duloxetine and the previous antidepressant medication will be discontinued. PTSD subjects will have a minimum score of 50 on the Clinician-Administered PTSD Scale (CAPS; Blake et al, 1995). Participants will be enrolled until the number of 20 subjects who complete the study is reached. All subjects are required to be in a medically stable condition as determined by a thorough physical examination, including ECG, blood work and urine analysis. No vulnerable subjects will be recruited for this study. Exclusion criteria: comorbid diagnosis of bipolar illness, schizophrenia or other psychotic disorders or presence of psychotic symptoms acute or chronic suicidality acute or chronic unstable medical conditions (including severely impaired hepatic function as indicated with abnormal PT and PTT, abnormal CBC, and liver enzymes more than 50% above the upper normal range, not well controlled blood pressure) current diagnosis of substance abuse or dependence unsuccessful treatment history with duloxetine, known hypersensitivity to duloxetine or any of its inactive ingredients administration of any investigational drug up to 90 days before entry into the study intake of monoamino oxides inhibitors up to 90 days before entry into the study or during the study subjects with a positive screen for drugs of abuse no startle or skin conductance response, or excessively high startle response to the startle probe (100 dB acoustic stimuli) during the pretest patients with uncontrolled narrow-angle glaucoma Pregnant as indicated by urine pregnancy test or unwillingness to prevent conception during the course of the study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alexander Neumeister, MD

Organizational Affiliation

Yale University

Official's Role

Principal Investigator

Facility Information:

Facility Name

VA Connecticut Healthcare System

City

West Haven

State/Province

Connecticut

ZIP/Postal Code

06516

Country

United States

12. IPD Sharing Statement

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Effects of Duloxetine on Fear Conditioning in Posttraumatic Stress Disorder (PTSD)

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