Combined Treatment of Prolonged Exposure and Pramipexole for Posttraumatic Stress Disorder and Depression
Stopped early · Phase 3
Conditions studied: PTSD, MDD
In brief
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 disorder (PTSD) and depression (MDD). Resting state functional connectivity (rsFC) will be assessed at baseline and en of treatment.
Key facts
- Study ID
- NCT03765138
- Run by
- Research Foundation for Mental Hygiene, Inc.
- People needed
- 1
- Starts
- 2019-02-19
- Expected to finish
- 2019-08-26
- Last updated by the study team
- 2019-11-26
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- New York State Psychiatric Institute — New York, New York, United States
Full record on ClinicalTrials.gov
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