Combined Treatment of Prolonged Exposure and Pramipexole for Posttraumatic Stress Disorder and Depression
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|ClinicalTrials.gov Identifier: NCT03765138|
Recruitment Status : Recruiting
First Posted : December 5, 2018
Last Update Posted : December 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|PTSD MDD||Combination Product: PE/Pramipexole||Phase 3|
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 greater distress and poorer treatment outcome. Functional magnetic resonance imaging (fMRI) show that relative to PTSD alone, PTSD-MDD is associated with decreased resting state functional connectivity (rs-FC) in both fear- and reward-processing circuits. In addition, our data suggest that Prolonged Exposure (PE), first-line PTSD treatment, may successfully target impairments in the fear circuits, but not in the reward circuits, which may explain the treatment-refractory quality of PTSD-MDD.
The goal of this pilot study is to test the feasibility, safety and initial efficacy of an integrated therapeutic approach targeting both fear and reward impairments in PTSD-MDD patients. Specifically, the investigators will examine a combination treatment with PE, shown to effectively address fear circuitry deficits, and Pramipexole, a dopamine agonist, shown to increase reward circuit function and to have promise in treating depression but not previously studied in PTSD. The central hypothesis is that combined PE/Pramipexole will a) improve PTSD and depressive symptoms in PTSD-MDD patients, and b) increase functional connectivity of fear and reward pathways as measured by fMRI rs-FC. In this pilot study, 15 adults aged 18-60 years with PTSD-MDD will receive combined 10-week of PE and Pramipexole up to the maximum dose of 4mg a day. Clinical assessment will be conducted at baseline, week 5, post treatment and at 3-month follow up. Behaviorally assessments including the probabilistic reward task (PRT) and attention allocation tasks, and fMRI scans for resting state functional connectivity (rs-FC) will be conducted at baseline and end of treatment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Combined Prolonged Exposure and Pramipexole Treatment for Patients With PTSD and Depression|
|Estimated Study Start Date :||November 25, 2018|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||March 1, 2020|
Experimental: Prolonged Exposure/Pramipexole Prolonged Exposure (PE) Therapy consists of 10 sessions of 90-minute duration, normally conducted once a week. In addition to receiving PE as described above, patients will have Pramipexole treatment.
Combination Product: PE/Pramipexole
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.
- Change in PTSD symptoms as measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) [ Time Frame: Baseline, Week 5, Week 10, 3 month follow up ]The CAPS is the gold standard in PTSD assessment. It is a 30-item structured interview used for current (past week or month) and lifetime diagnosis of PTSD. The CAPS was designed to be administered by clinicians and clinical researchers who have a working knowledge of PTSD. The full interview takes 45-60 minutes to administer. Scores range from 0 to 80 with higher values represent a worse outcome.
- Change in depressive symptoms as measured by the Hamilton Rating Scale for Depression (HRSD). [ Time Frame: Baseline, Week 5, Week 10, 3 month follow up ]The Hamilton Rating Scale for Depression is a 17-item instrument that was designed to measure frequency and intensity of depressive symptoms in individuals with major depressive disorder. Ratings are made using either a five- or a three-point scale, yielding total scores from 0 to 61, with higher values represent a worse outcome.
- Changes in functional connectivity of fear and reward pathways as measured by functional magentic resonance imaging (fMRI) resting state functional connectivity (rs-FC). [ Time Frame: baseline and week 10. ]The investigators will use fMRI scans at baseline and posttreatment to assess connectivity in fear and reward circuits
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03765138
|Contact: Shay Arnon, BA||(646) 774-8106||Shay.Arnon@nyspi.columbia.edu|
|Contact: Sara Such, BA||646-774-8104||Sara.Such@nyspi.columbia.edu|
|United States, New York|
|New York State Psychiatric Institute||Recruiting|
|New York, New York, United States, 10032|
|Contact: Yuval Neria, PhD 646-774-8092 Yuval.email@example.com|
|Contact: Franklin Schneier, MD 646 823 3863 Franklin.firstname.lastname@example.org|
|Principal Investigator:||Yuval Neria, PhD||Columbia Psyhciatry and New York State Psychiatric Institute|