posttraumatic stress disorder
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Patients diagnosed with posttraumatic stress disorder (2) Individuals who can understand the nature of this study and provide informed consent
Exclusion criteria
Exclusion criteria: (1) Patients with duration of illness less than 6 months (2) Individuals who received specific psychotherapy (e.g., prolonged exposure therapy, cognitive processing therapy, and eye movement desensitization and reprocessing therapy) within 3 months prior to the recruitment into the study (3) Patients with comorbid schizophrenia, severe manic phase of bipolar disorder, or intellectual disability (4) Individuals with serious suicidal ideation (5) Individuals with severe physical illnesses that can interfere with study participation (6) Pregnant women (7) Individuals with the following physical conditions that are described in manufacturer's package insert as "careful administration": -History of epilepsy or convulsion -Renal dysfunction -Factors increasing urine pH -Severe liver dysfunction (8) Patients considered unqualified for the study by their attending physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1) PTSD diagnosis/severity (PTSD Diagnostic Scale: PDS) | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) PTSD severity (Impact of Event Scale-Revised: IES-R) (2) Cognitive function (Repeatable Battery for the Assessment of Neuropsychological Status: RBANS) (3) Depressive symptoms (Beck Depression Inventory-II) (4) Anxiety symptoms (State-Trait Anxiety Inventory) (5) Cognitive changes after traumatic events (Posttraumatic Cognitions Inventory) (6) Overall symptom severity/improvement (Clinical Global Impression) (7) Adverse events (UKU Side-Effect Rating Scale) | — |
Countries
Japan
Contacts
National Institute of Mental Health, National Center of Neurology and Psychiatry Department of Behavioral Medicine