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

This study has been completed.
VA Connecticut Healthcare System
Information provided by (Responsible Party):
Yale University Identifier:
First received: December 25, 2007
Last updated: April 21, 2015
Last verified: April 2015

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.

Condition Intervention Phase
Posttraumatic Stress Disorder Drug: Duloxetine Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effects of Duloxetine on Fear Conditioning in PTSD

Resource links provided by NLM:

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Anxiolytic and antidepressant effects of duloxetine in patients with chronic PTSD [ Time Frame: 8 weeks ]

Enrollment: 26
Study Start Date: February 2007
Study Completion Date: December 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PTSD
Drug: Duloxetine

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

Other Name: Cymbalta


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00763178

United States, Connecticut
VA Connecticut Healthcare System
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Yale University
VA Connecticut Healthcare System
Principal Investigator: Alexander Neumeister, MD Yale University
  More Information

Responsible Party: Yale University Identifier: NCT00763178     History of Changes
Other Study ID Numbers: 0612002110
Study First Received: December 25, 2007
Last Updated: April 21, 2015

Keywords provided by Yale University:

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents processed this record on September 25, 2017