Status:
TERMINATED
Combined Treatment of Prolonged Exposure and Pramipexole for Posttraumatic Stress Disorder and Depression
Lead Sponsor:
Research Foundation for Mental Hygiene, Inc.
Conditions:
PTSD
MDD
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief Summary
This pilot study aims to test the safety, feasibility, and initial efficacy of combined 10 week treatment of prolonged exposure (PE) and Pramipexole in patients with comorbid posttraumatic stress diso...
Detailed Description
Approximately half of the individuals with posttraumatic stress disorder (PTSD) present with major depressive disorder (MDD). Compared to PTSD alone, patients with comorbid PTSD-MDD demonstrate greate...
Eligibility Criteria
Inclusion
- Males or females between the ages of 18 and 60
- Current DSM-V diagnosis of PTSD comorbid with MDD
- CAPS-5 ≥ 25, and 17-item HRSD ≥ 17
- Able to give consent, fluent in English
Exclusion
- Prior or current diagnosis with traumatic brain injury, bipolar disorder, psychotic disorder, gambling or impulse control disorders, or dementia
- History of psychosis, psychotic disorder, mania or bipolar disorder
- Severe substance use disorder excluding nicotine (i.e., nicotine use disorder and mild-moderate alcohol/cannabis use disorder are accepted)
- Individuals at risk for suicide based on history and current mental state. BDI-II suicide item \> 2 or CGI-Severity baseline score of 7.
- Treatment with antidepressants or other psychotropic medication in the past 4 weeks (or 6 weeks for fluoxetine; an exception will be made for zolpidem used intermittently for sleep).
- Pregnancy or plans to become pregnant during the period of the study.
- Current psychotherapy
- Current unstable or untreated medical illness
- Any condition that would exclude clinical MRI exam (e.g. pacemaker, paramagnetic metallic prosthesis, surgical clips, shrapnel, necessity for constant medicinal patch, some tattoos, severe obesity, claustrophobia)
- History of untoward reaction to pramipexole
Key Trial Info
Start Date :
February 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 26 2019
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT03765138
Start Date
February 19 2019
End Date
August 26 2019
Last Update
November 26 2019
Active Locations (1)
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1
New York State Psychiatric Institute
New York, New York, United States, 10032