Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Yale University
With
VA Connecticut Healthcare System
Age
18–65
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
