Posttraumatic Stress Disorder Research
Principal Investigator: Franklin Schneier, MD
Overview of the Study:
Sertraline (Zoloft) and paroxetine (Paxil) are the only medications that have been FDA-approved for treatment of PTSD, but they are not fully effective for all patients. One approach to improve treatment of PTSD is to combine these SSRI-type medications with another medication, Mirtazapine (Remeron, Avanza, Zispin) that is a marketed antidepressant. The combination of SSRI medication with mirtazapine has improved response in studies of treatment of depression. The overall goal of this study is to examine whether combined mirtazapine and sertaline treatment is superior to sertraline alone in the treatment of PTSD over 24 weeks.
Sixty patients with chronic PTSD will be randomized to double-blind treatment with:
- sertraline + mirtazapine
- sertraline + placebo
Patients who show at least a minimal response after 12 weeks will continue for another 12 weeks on the same study treatment.
Principal Investigator: Yuval Neria, PhD
Overview of the Study:
PTSD is a common anxiety disorder that follows exposure to an overwhelming traumatic event. People diagnosed with PTSD tend to experience severe difficulties in emotional, social, and occupational functioning. The most effective psychotherapy for PTSD is Prolonged Exposure treatment. Yet even with this treatment, a large number of patients continue to experience PTSD symptoms. The question why some patients who receive prolonged exposure treatment will recover from PTSD while other patients will not remained unanswered.
Our study will seek to answer this question by investigating brain circuitry involved in PTSD and in response to Prolonged Exposure treatment. Patients with PTSD and trauma exposed people who didn’t develop PTSD, and are interested in participating in the study will be assessed by functional MRI and Skin Conductance Response (SCR) measures to determine the neural activation to a an extinction learning task. All PTSD patients and half of the trauma exposed individuals will repeat these procedures 10 weeks later, after PTSD patients have completed 10 weeks of intensive Prolonged Exposure treatment. Clinical ratings of PTSD severity will be conducted at four time points: before treatment, at week 7, after treatment and at 3 months follow-up.
NO LONGER RECRUITING
Principal Investigator: John Markowitz, MD
Overview of the Study:
Posttraumatic stress disorder (PTSD) is a prevalent, debilitating psychiatric disorder. Only two types of treatment have shown efficacy for chronic PTSD in replicated research: exposure-based cognitive behavioral therapies (CBTs) and serotonin reuptake inhibitors. Prolonged Exposure (PE) studies have shown that repeated exposure to memories and reminders of trauma is an effective way to treat PTSD. Yet multiple studies also document a central role for social and interpersonal processes in recovery after trauma, and exposure to reminders of trauma may not be the only way to treat PTSD.
Interpersonal Psychotherapy (IPT), a well established treatment for mood disorders, differs in theory and technique from CBT. It focuses on the relationship between symptoms and social environment: how feelings affect interactions with other people, and how encounters with other people affect feelings. Our pilot study found IPT had great promise for PTSD. Unlike CBT treatments for PTSD, IPT targets interpersonal functioning, encouraging neither reexperiencing of traumatic memories nor out-of-session exposure to reminders of the trauma. IPT is thus a plausible alternative treatment approach. Relaxation Therapy, a treatment that helps patients learn to relax their bodies and minds, has shown benefits in treating PTSD in multiple studies.
We are now conducting a randomized psychotherapy study comparing 14 weeks of IPT, Prolonged Exposure therapy, and Relaxation therapy for 165 patients with chronic PTSD. Therapists are highly trained and expertly supervised. Expert independent evaluators make careful diagnoses and assess outcomes. Responders to treatment enter a three-month observational follow-up phase to assess whether treatment gains persist. This state-of-the-art study, funded by the National Institute of Mental Health (MH079078; clinicaltrials.gov #NCT00739765), presents a rare and nearly ideal opportunity to study psychotherapy mechanisms by contrasting three very different treatments. The study explores hypotheses about treatment mechanism by studying the timing of exposure-related change and interpersonal change in the treatments. Patients receive a small payment for completing assessments and also have the option to participate in a MRI neuroimaging study to measure the effect of psychotherapy for PTSD on the brain.