fMRI Predictors of Treatment Response in Posttraumatic Stress Disorder (PTSD)

Completed · Not applicable

Conditions studied: Posttraumatic Stress Disorder (PTSD)

In brief

To employ a fear learning-extinction paradigm with functional magnetic resonance imaging (fMRI) and skin conductance response (SCR) assessments among patients with posttraumatic stress disorder (PTSD) and trauma exposed healthy controls, aiming to a) clarify neural circuits underlying PTSD and b) to probe brain based predictors of symptomatic improvement in response to Prolonged Exposure (PE) treatment, and first line treatment for PTSD.

Key facts

Study ID

NCT01576510

Run by

Research Foundation for Mental Hygiene, Inc.

People needed

95

Starts

2010-08-01

Expected to finish

2014-06-01

Last updated by the study team

2014-06-24

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Males or females between the ages of 18 and 60
• Current DSM-IV PTSD
• CAPS score equal or greater than 50.
• Able to give consent, fluent in English or Spanish.

You may not qualify if…

• History of Axis I psychiatric diagnosis (other than as specified), e.g., psychotic disorder, bipolar disorder, obsessive compulsive disorder (OCD), tic disorder, or eating disorder. Note that comorbid current major depressive disorder will be allowed in up to one half of the PTSD group. This will enable inclusion of this common comorbidity, but also enable an assessment of whether or not the presence of this comorbid diagnosis is driving any observed significant between-group differences.
• Depression which is antecedent to PTSD; score of > 25 on the Hamilton Rating Scale for Depression (HAM-D-17-item); significant depression and /or depression related impairment that is judged to warrant pharmacotherapy or combined medication and psychotherapy.
• Individuals at risk for suicide based on history and current mental state.
• History of substance/alcohol dependence within the past six months, and abuse within past two months
• Patients who are receiving effective medication for their PTSD and/or depression
• Antipsychotic, antidepressant, or mood stabilizer medications in the last 4 weeks prior to the study (6 weeks for fluoxetine). Standing daily dosing of benzodiazepine class of medication in the 2 weeks prior to the study (as needed use of benzodiazepines is not an exclusion, but must be clinically judged to tolerate no benzodiazepines for the 72-hour period before each of the fMRI days). Triptan anti-migraine medications. Other medications that may interfere with fear circuitry and fear memory such as blood-brain-barrier-penetrating β-blockers.
• Pregnancy, or plans to become pregnant during the period of the study.
• Paramagnetic metallic implants or devices contraindicating magnetic resonance imaging or any other non-removable paramagnetic metal in the body.
• Formal CBT psychotherapy initiated within 3 months of beginning this study.
• Medical illness that could interfere with assessment of diagnosis, treatment response or biological measures (SCR, fMRI), including organic brain impairment from stroke, CNS tumor, or demyelinating disease; and renal, thyroid, hematologic or hepatic impairment
• Current unstable or untreated medical illness, and resting SBP≥140 and DBP≥90 and HR<60 and HR>100
• Any condition that would exclude clinical MR exam (e.g. pacemaker, paramagnetic metallic prosthesis, surgical clips, shrapnel, necessity for constant medicinal patch, some tattoos)
• Significant claustrophobia that would preclude ability to remain calm within the MRI scanner

Where it is running

• New York State Psychiatric Institute — New York, New York, United States

Full record on ClinicalTrials.gov

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