Combined Treatment of Prolonged Exposure and Pramipexole for Posttraumatic Stress Disorder and Depression
Condition: PTSD; MDD
MeSH terms: Depression
Intervention: PE/Pramipexole
Intervention description: Experimental: PE/Pramipexole Prolonged Exposure (PE) Therapy consists of 10 sessions of 90-minute duration, normally conducted once a week. Elements of PE include imaginal and in vivo exposure to trauma reminders; breathing retraining; cognitive restructuring; and PTSD psychoeducation.
Pramipexole: In addition to receiving PE as described above, patients will have Pramipexole treatment. Daily dose will be started at 0.25 mg/day and increased by 0.25 mg/day every 3-4 days to a target of 2.5mg day by week 5. Beginning week 6 daily dose will be increased weekly by 0.5 mg/day to a maximum dose of 4mg. Dose will be increased as tolerated unless the patient has achieved remission and will be decreased in the event of intolerable adverse events.
Intervention MeSH terms: Pramipexole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

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 disorder (PTSD) and depression (MDD). Resting state functional
      connectivity (rsFC) will be assessed at baseline and en of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males or females between the ages of 18 and 60

          2. Current DSM-V diagnosis of PTSD comorbid with MDD

          3. CAPS-5 ≥ 25, and 17-item HRSD ≥ 17

          4. Able to give consent, fluent in English

        Exclusion Criteria:

          1. Prior or current diagnosis with traumatic brain injury, bipolar disorder, psychotic
             disorder, gambling or impulse control disorders, or dementia

          2. History of psychosis, psychotic disorder, mania or bipolar disorder

          3. Severe substance use disorder excluding nicotine (i.e., nicotine use disorder and
             mild-moderate alcohol/cannabis use disorder are accepted)

          4. Individuals at risk for suicide based on history and current mental state. BDI-II
             suicide item > 2 or CGI-Severity baseline score of 7.

          5. 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).

          6. Pregnancy or plans to become pregnant during the period of the study.

          7. Current psychotherapy

          8. Current unstable or untreated medical illness

          9. 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)

         10. History of untoward reaction to pramipexole