Post-Traumatic Stress Disorder Clinical Trial
Official title:
BRL29060A in Posttraumatic Stress Disorder
Verified date | March 2014 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | Japan: Ministry of Health, Labor and Welfare |
Study type | Interventional |
This was a 52-week, non-comparative, uncontrolled study of paroxetine in Japanese PTSD patients to obtain clinical experience regarding efficacy and safety. In this study, subjects received paroxetine 20mg-40mg once daily after an evening meal.
Status | Completed |
Enrollment | 52 |
Est. completion date | June 2005 |
Est. primary completion date | November 2004 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Patients with a primary diagnosis of PTSD according to DSM-IV criteria (Posttraumatic Stress Disorder: 309.81). In order to diagnose PTSD, the Clinician-Administered PTSD Scale-DX Current and Lifetime Diagnostic Version (CAPS-DX) will be used. - Disease to Be Treated: - Duration of illness of at least 3 months at Week -1. - Score >= 50 on Criteria B, C and D of CAPS-SX. - Age: >=18 - <65 years (at the time of acquisition of informed consent) - Sex: No restriction - Hospitalization Status: No restriction - Informed consent: Gives his/her informed consent. In case of a subject who is under the age of 20, his/her parent/guardian must also give his/her written informed consent. Exclusion Criteria: Exclusion Criteria at Week -1 - Patients diagnosed with Axis I disorders (excluding PTSD) such as major depression, dysthymia, simple phobia, OCD, or panic disorder as a primary diagnosis according to DSM-IV criteria within 24 weeks prior to Week -1. However, patients with depressive disorders are allowed to enroll in the study, if PTSD was present before the depressive disorders appeared and PTSD is the predominant disorder. - Patients presenting a current major depressive episode that preceded the diagnosis of PTSD. However, patients with depressive disorders are allowed to enroll in the study, if PTSD was present before the depressive disorders appeared and PTSD is the predominant disorder. - Patients receiving disability payments because of PTSD or any other psychiatric disorder. - Patients currently engaged in compensation litigation whereby personal gain would be achieved from prolonged symptoms of PTSD or any other psychiatric disorders. - Patients taking St. Johns Wort. - Patients who meet DSM-IV criteria for substance abuse (alcohol or drugs) or substance dependence within 24 weeks prior to Week -1. - Patients who have attempted suicide within 24 weeks prior to Week -1 or who pose, in the investigator's judgement using the M.I.N.I. "C. Suicidality", a high suicidal risk. - Women who are pregnant or lactating, who may be pregnant, or who plan for pregnancy during the study. - Patients who have taken MAO inhibitors within 1 week prior to Week -1 (or within 2 weeks prior to Week 0). - Patients who have had electroconvulsive therapy (ECT) within 12 weeks prior to Week -1. - Patients who have been treated with another investigational drug within 12 weeks prior to Week -1. - Patients with a history or complication of manic psychosis. - Patients with a history or complication of convulsive disorder (epilepsy, etc.). - Patients with a complication of glaucoma. - Patients with a known tendency for bleeding or those with predisposing conditions. - Patients with a history of hypersensitivity to paroxetine. - Patients with any serious organic disorder in the brain. - Patients with any serious physical symptom such as cardiac, hepatic, renal or hematopoietic dysfunction. - Patients with a history or complication of cancer or malignant tumor. - Others whom the investigator or sub-investigator considers ineligible for the study. Exclusion Criterion at Week 0 - Patients whose placebo run-in medication compliance is less than 80%. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
Kim Y, Asukai N, Konishi T, Kato H, Hirotsune H, Maeda M, Inoue H, Narita H, Iwasaki M. Clinical evaluation of paroxetine in post-traumatic stress disorder (PTSD): 52-week, non-comparative open-label study for clinical use experience. Psychiatry Clin Neurosci. 2008 Dec;62(6):646-52. doi: 10.1111/j.1440-1819.2008.01862.x. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in the Clinician-Administered Posttraumatic Stress Disorder Scale One Week Symptom Status Version (CAPS-SX) total score | 52 weeks | No | |
Secondary | Proportion of responders based on the CGI Global Improvement | 52 weeks | No | |
Secondary | Change from baseline in the CAPS-SX re-experiencing cluster score | 52 weeks | No | |
Secondary | Change from baseline in the CAPS-SX avoidance/numbing cluster score | 52 weeks | No | |
Secondary | Change from baseline in the CAPS-SX hyperarousal cluster score | 52 weeks | No | |
Secondary | Change from baseline in the CGI Severity of Illness score | 52 weeks | No | |
Secondary | Adverse events (AEs), abnormal findings in each examination/test, and their details: Laboratory tests (hematology, clinical chemistry, electrolytes, urinalysis), Blood pressure, pulse rate, body weight | 52 weeks | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04317820 -
Deep Brain Reorienting in Post-traumatic Stress Disorder
|
N/A | |
Completed |
NCT05112003 -
Translingual Neurostimulation for the Virtual Treatment of Post-Traumatic Stress Disorder: A Feasibility Pilot
|
N/A | |
Recruiting |
NCT04518267 -
Anger and Psychotrauma: Data From Military and Civilians
|
||
Completed |
NCT02502604 -
Cognitive Training Program for Individuals With Depression and Post-Traumatic Stress Disorder
|
N/A | |
Terminated |
NCT02234687 -
A mGlu2/3 Agonist in the Treatment of PTSD
|
Phase 1 | |
Completed |
NCT02256566 -
Cognitive Training for Mood and Anxiety Disorders
|
N/A | |
Terminated |
NCT02520726 -
PTSD Prevention Study Examining the Efficacy of Sertraline in Burn Victims
|
Phase 4 | |
Completed |
NCT01738308 -
The Effects of Healing Touch on Post Operative Pediatric Patients
|
N/A | |
Completed |
NCT02213900 -
Preventing Post-Operative Delirium in Patients Undergoing a Pneumonectomy, Esophagectomy or Thoracotomy
|
Phase 4 | |
Completed |
NCT01517711 -
Tramadol Extended-Release (ER) for Posttraumatic Stress Disorder (PTSD)
|
Phase 4 | |
Completed |
NCT01437891 -
Sentra AM® and Sentra PM® for Post-traumatic Stress Disorder (PTSD) and Gulf War Fibromyalgia (GWF)
|
N/A | |
Completed |
NCT01199107 -
Maximizing Treatment Outcome and Examining Sleep in Post-traumatic Stress Disorder (PTSD)
|
Phase 3 | |
Completed |
NCT01998100 -
Maximizing Treatment Outcome in Post-Traumatic Stress Disorder (PTSD)
|
Phase 3 | |
Completed |
NCT01231711 -
Improving Quality-of-life and Depressive Symptoms of Combat Veterans Via Internet-based Intervention
|
Phase 1 | |
Completed |
NCT00680524 -
Telephone-based Care for OEF/OIF Veterans With PTSD
|
N/A | |
Completed |
NCT00838006 -
Psychophysiologic Predictors of Post-deployment Mental Health Outcomes
|
N/A | |
Completed |
NCT00348036 -
Group Intervention for Interpersonal Trauma
|
N/A | |
Completed |
NCT00525226 -
Evaluating the Effects of Stress in Pregnancy
|
N/A | |
Completed |
NCT00183690 -
Prolonged Exposure Therapy Versus Active Psychotherapy in Treating Post-Traumatic Stress Disorder in Adolescents
|
Phase 1 | |
Completed |
NCT00158262 -
Effect of Propranolol on Preventing Posttraumatic Stress Disorder
|
Phase 4 |