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

• Status: Terminated
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: New York University School of Medicine; NYU Langone Health
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Sertraline

Criteria

Inclusion Criteria:

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 Criteria:

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