Cognitive Behavioral Therapy Versus Sertraline in the Treatment of Post-Traumatic Stress Disorder

Stopped early · Phase 4

Conditions studied: Post-Traumatic Stress Disorder

In brief

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.

Key facts

Study ID

NCT00391430

Run by

NYU Langone Health

People needed

39

Starts

2005-05-01

Expected to finish

2009-07-01

Last updated by the study team

2021-07-21

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• NYU Institute for Trauma & Resilience — New York, New York, United States

Full record on ClinicalTrials.gov

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