Status:
TERMINATED
Cognitive Behavioral Therapy Versus Sertraline in the Treatment of Post-Traumatic Stress Disorder
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Post-Traumatic Stress Disorder
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
Brief Summary
This study will evaluate which parts of the brain are affected by treatment with behavioral therapy versus medication therapy in people with post-traumatic stress disorder.
Detailed Description
Post-traumatic stress disorder (PTSD) is an anxiety disorder that can develop after exposure to a traumatic event. PTSD symptoms may include emotional numbness, loss of interest in activities that wer...
Eligibility Criteria
Inclusion
- For people with PTSD:
- Meets DSM-IV criteria for PTSD
- Medically healthy
- Right handed
- Learned English prior to age 5
- Agrees to use an effective form of contraception throughout the study
- For healthy controls:
- Medically healthy
- Right handed
- Has experienced a qualifying traumatic event
- Does not meet DSM-IV criteria for present or past PTSD
- Learned English prior to age 5
- Agrees to use an effective form of contraception throughout the study
Exclusion
- For people with PTSD:
- Meets DSM-IV criteria for panic disorder within 6 months prior to study entry
- Current suicide risk
- History of DSM-IV diagnosis of any the following conditions: schizophrenia, bipolar mood disorder, obsessive compulsive disorder (including trichotillomania), or eating disorder
- Meets DSM-IV criteria for substance use or dependence within the 6 months prior to study entry
- Any substance abuse within 2 weeks prior to study entry
- Score of greater than 22 on the 17-item Hamilton Rating Scale for Depression (HAM-D) with depressive symptoms secondary to PTSD
- Current participation in cognitive behavioral psychotherapy that is specifically designed to treat PTSD
- Concomitant psychoactive medications
- History of cerebrovascular accident (CVA) or any disorder that causes chronic neurological problems
- Medical illness with central nervous system (CNS) involvement or currently taking medication that affects the CNS
- Unstable general medical illness requiring intervention (e.g., HIV infection)
- Pregnant, breastfeeding, or plans to become pregnant
- Presence of internal metallic objects, such as heart pacemaker, shrapnel, bullets, surgical prostheses, surgical clips, or pins
- History of gastric bypass surgery
- For healthy controls:
- Any history of generalized anxiety disorder or panic disorder
- Any history of psychotic disorder, bipolar disorder, or cyclothymia
- Any history of substance abuse or dependence within the 6 months prior to study entry
- Any substance use within 2 weeks prior to study entry
- Any other Axis I disorder within the year prior to study entry, including obsessive-compulsive disorder and trichotillomania
- Unstable general medical illness requiring intervention (e.g., HIV infection)
- Presence of internal metallic objects, such as heart pacemaker, shrapnel, bullets, surgical prostheses, surgical clips, or pins
- Concomitant psychoactive medications
- Patients with a history of cerebrovascular accident (CVA) or any disorder that causes chronic neurological problems
- Medical illness with central nervous system (CNS) involvement or currently taking medication that affects the CNS
- Cognitive impairment or severe Axis II disorder that will likely affect participation in the study
- Pregnant, breastfeeding, or plans to become pregnant
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00391430
Start Date
May 1 2005
End Date
July 1 2009
Last Update
July 21 2021
Active Locations (1)
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1
NYU Institute for Trauma & Resilience
New York, New York, United States, 10016