Paroxetine-CR to Treat Post-Traumatic Stress Disorder (PTSD) Symptomatic After Initial Exposure Therapy

This is a systematic controlled study examining the use of augmentation with pharmaotherapy for PTSD patients remaining symptomatic despite CBT (exposure therapy). The aims of the study include examination of: (1) the efficacy of paroxetine-CR compared to placebo as additions to ongoing exposure therapy in patients who failed to respond to brief, intensive CBT; (2) the tolerability of paroxetine-CR compared to placebo as additions to ongoing exposure therapy in patients who failed to respond to brief, intensive CBT; (3) the outcome of patients at 6 months follow-up to randomized treatment. Patients will initially have intensive (8 sessions over 4 weeks) prolonged exposure therapy. Patients who remain symptomatic will be randomzied to receive either flexibly-dosed paroxetine-CR (12.5 mg/d - 62.5 mg/d) or placebo in conjunction with additional 5 sessions of prolonged exposure over 10 weeks.

Inclusion criteria

• Male or female outpatients at least 18 years of age with a primary (the condition that is most central to the patient's current distress) psychiatric diagnosis of PTSD as defined by DSM-IV criteria
• Patients must have remained symptomatic (CGI-S > or = 3) and a score of at least 6 on the SPRINT after a minimum of 7 sessions of prolonged exposure (delivered within 6 weeks) to be eligible for randomized treatment.

Exclusion criteria

• Serious medical illness or instability for which hospitalization may be likely within the next 3 months
• Pregnant or lactating women or those of childbearing potential not using medically accepted forms of contraception
• Concurrent use of other psychotropic medications
• Lifetime diagnosis of schizophrenia or any other psychotic disorder, mental retardation, organic mental disorders, or bipolar disorder
• Obsessive-Compulsive Disorder, eating disorders, or alcohol/substance abuse disorders within the last 6 months
• A current primary diagnosis of major depression, dysthymia, social anxiety disorder, and generalized anxiety disorder
• A history of hypersensitivity or poor response to paroxetine or those using antidepressants, buspirone, or beta-blockers within 2 weeks of randomization
• Concurrent dynamic or supportive psychotherapy if started within 2 months prior to onset of study entry