NCT00672776.
| Methods | Study type: Interventional (clinical trial) Actual enrolment: 40 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (participant, care provider, investigator, outcomes assessor) |
| Participants | Inclusion criteria: Quote: "Male and female patients meeting Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV) criteria for PTSD assessed by the Structured Clinical Interview for DSM IV (SCID); All patients with PTSD will be greater than 18 years of age, and will be required to give informed consent; Patients will be recruited from newspaper advertisements and fliers; All patients must be free of major medical illness on the basis of history and physical examination, lab testing, and electrocardiogram, and must not be actively abusing substances or alcohol; Patients should be free of psychotropic medications for four weeks before the study" Exclusion Criteria: Quote: "Pregnant and breast‐feeding women will not be studied. Female subjects will be required to have a negative pregnancy test before the study. Female subjects of childbearing age will be advised to use barrier contraception for the duration of the study, in addition to other forms of contraception that they may be using; Serious medical or neurological illness or a hypersensitivity to paroxetine; Past or present steroid use; Electroconvulsive therapy (ECT) within the 6 months prior to study entry; Organic mental disorders or epilepsy; History of head trauma; Cerebral infectious disease or dyslexi; History of psychosis, schizophrenia, or eating disorders; Active suicidality or homicidality" |
| Interventions | Experimental: 1, paroxetine Placebo comparator: 2, placebo |
| Outcomes | Primary outcome measures: brain function with traumatic reminders (Time frame: 3 months), PET measurement of brain activation before and after paroxetine or placebo treatment |
| Notes | Study start date: June 2008 Actual primary completion date: September 2007 Actual study completion date: September 2007 Principal investigator: J. Douglas Bremner, M.D. |