Effects of Duloxetine on Fear Conditioning in Posttraumatic Stress Disorder (PTSD)
Recruitment status was Recruiting
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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 |
- 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 |
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| Contact: Sue Kasserman, BSN | 203-932-5711 ext 4447 | sue.kasserman@va.gov |
| United States, Connecticut | |
| VA Connecticut Healthcare System | Recruiting |
| West Haven, Connecticut, United States, 06516 | |
| 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 Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Serotonin Agents Physiological Effects of Drugs Adrenergic Uptake Inhibitors Adrenergic Agents Dopamine Uptake Inhibitors Dopamine Agents Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013