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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Yale University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
VA Connecticut Healthcare System
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00763178
First received: December 25, 2007
Last updated: September 29, 2008
Last verified: September 2008
  Purpose

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
Phase 0

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 25
Study Start Date: February 2007
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PTSD
Duloxetine
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


  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00763178

Contacts
Contact: Sue Kasserman, BSN 203-932-5711 ext 4447 sue.kasserman@va.gov

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

No publications provided

Responsible Party: Dr. Alexander Neumeister, Yale University
ClinicalTrials.gov Identifier: NCT00763178     History of Changes
Other Study ID Numbers: 0612002110, M120627
Study First Received: December 25, 2007
Last Updated: September 29, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
PTSD

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Duloxetine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Adrenergic Uptake Inhibitors
Adrenergic Agents
Dopamine Uptake Inhibitors
Dopamine Agents

ClinicalTrials.gov processed this record on August 21, 2014