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Clinical Evaluation of BRL29060A (Paroxetine Hydrochloride Hydrate) in Posttraumatic Stress Disorder (PTSD)

This study is currently recruiting participants.
Verified by GlaxoSmithKline, September 2008

Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00557622
  Purpose

This is a single-blind, placebo-controlled, parallel group study to evaluate the efficacy of BRL29060A (paroxetine hydrochloride hydrate, hereafter paroxetine) administered orally over the dose range of 20 mg to 50 mg once daily after supper for 12 weeks in Japanese patients with posttraumatic stress disorder (PTSD) as assessed by the change from baseline in CAPS-SX total score. Also the effect of paroxetine on regional cerebral blood flow (rCBF) induced by subthreshold emotional arousing (or symptom stimulating) tasks will be determined using functional magnetic resonance imaging (fMRI) for exploratory assessment of the correlation between the change in rCBF and the efficacy.

The sample size is 30 subjects. The study period consists of 4 weeks of run-in phase, 12 weeks of treatment phase, 0-3 weeks of taper phase and follow-up examination at 2 weeks after the last dose, for a total of 18-21 weeks.

Subjects will visit the clinic at the start of run-in phase, Week -2, the start of treatment phase, Weeks 2, 4, 6, 8 and 12 of treatment, and follow-up examination.


Condition Intervention Phase
Posttraumatic Stress Disorder (PTSD)
Drug: BRL29060A
Phase II

MedlinePlus related topics:   Post-Traumatic Stress Disorder    Stress   

ChemIDplus related topics:   Paroxetine    Paroxetine hydrochloride    Paroxetine Mesylate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Clinical Evaluation of BRL29060A (Paroxetine Hydrochloride Hydrate) in Posttraumatic Stress Disorder (PTSD) - A Placebo-Controlled, Single-Blind Comparative Study -

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • •CAPS-SX score (at week 12)

Secondary Outcome Measures:
  • •Cerebral regional blood flow •CGI-GI •CGI-SI •CAPS-SX score (at week 4 and 8), subtotal in re-experiencing, avoidance and numbing, and increased arousal symptom •Study continuation rate [ Time Frame: A total of 18-21 Weeks ]
  • Change from the baseline of regional blood flow; Proportion of responders of CGI Global Improvement; Change from the baseline of CGI Severity of Illness
  • Change from the baseline of CAPS-SX total score (at week4 and week 8); Change from the baseline of CAPS-SX score relating re-experiencing; Change from the baseline of CAPS-SX score relating avoidance and numbing
  • Change from the baseline of CAPS-SX score relating increased arousal symptom; Study continuation rate

Estimated Enrollment:   30
Study Start Date:   November 2007
Estimated Study Completion Date:   May 2008
Estimated Primary Completion Date:   May 2008 (Final data collection date for primary outcome measure)

  Eligibility
Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Patients who are primarily diagnosed with PTSD (Posttraumatic Stress Disorder: 309.81) using DSM-IV-TR criteria. The CAPS-DX (Clinician-Administered PTSD Scale-DX) and M.I.N.I. (The Mini International Neuropsychiatric Interview, Japanese version 5.0.0. [2003]) will be used for diagnosis
  • Pathologic condition: Patients who experienced a motor vehicle accident (MVA) with severe or potential severe physical injury more than 3 months ago but less than 12 months ago
  • Patients aged 20 and <65 at the time of signing the Informed consent
  • Male and female patients
  • Inpatient/outpatient status: Both are permitted
  • Patients who are able to give written informed consent in person (i.e., patients who are capable of giving written informed consent on their own)
  • Patients whose combined score of the CAPS-SX standard B, C, and D is over 50

Exclusion Criteria:

  • Patients primarily diagnosed with a DSM-IV-TR Axis I disorder other than PTSD (e.g. major depressive disorder, dysthymic disorder, specific phobia [simple phobia], obsessive-compulsive disorder, panic disorder, etc.) within 6 months of week -4 (start of baseline phase)
  • Patients presenting with a current major depressive episode that preceded the diagnosis of PTSD
  • Patients receiving disability payments due to PTSD or other psychiatric diseases
  • Patients currently engaged in compensation litigation whereby personal gain would be achieved from prolonged symptoms of PTSD or any other psychiatric disorders
  • Patients who meet the DSM-IV-TR criteria for substance abuse or dependence (alcohol or drugs) within 6 months of Week -4 (start of baseline phase)
  • Patients with history of a suicide attempt within 6 months before Week -4 (start of baseline phase), or have, in the opinion of the investigator, "C. high risk of suicide" according to the MINI at Week -4
  • Patients who are pregnant, lactating or of childbearing potential and are likely to become pregnant
  • Patients receiving electro-convulsive therapy (ECT) prior to Week -4 (start of baseline phase)
  • Patients receiving another investigational product within 12 weeks before Week -4 (start of baseline phase)
  • Patients with a history or complication of manic psychosis
  • Patients with a history or complication of convulsive disorder (epilepsy, etc.)
  • Patients with a diagnosis or complication of a cognitive disorder (MMSE ?24 points)
  • Patients with a history and complication of serious cerebral organic disorder. (e.g. cerebrovascular disorder, meningitis, degenerative disease and other neurological disorders and seizures; however, bleeding in the upper arachnoid membrane should not be excluded)
  • Patients unable or unwilling to undergo the fMRI procedure (e.g., cerebrovascular clipping surgery, pacemaker, any internal metals with magnetism, and claustrophobia)
  • Patients with glaucoma
  • Patients with a known tendency for bleeding or those with predisposing conditions
  • Patients with a history of hypersensitivity to paroxetine
  • Patients with serious physical symptoms (cardiac, hepatic and renal dysfunction, or hematopoietic dysfunction, etc.). For seriousness, Grade 3 of "Criteria for seriousness of adverse reactions to drugs, etc. (Yakuan No.80)" is used as an index
  • Patients with a history or complication of cancer or malignant tumour
  • Patients with chronic hepatitis type B and/or C which is positive of hepatitis B surface antigen (HBsAg) and/or hepatitis C antibody
  • Others whom the investigator or sub-investigator considers ineligible for or unable to participate in the investigation
  • Criteria at Week 0 (start of Treatment Phase):

Subjects whose drug compliance rate for Drug 1 (Run-in Phase placebo) is <80% between Week -4 and Week 0;

Subjects whose CAPS-SX total score of the standard B, C, and D at Week 0 varied by 25% or more compared with those at Week -2

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00557622

Locations
Japan
GSK Clinical Trial Call Center     Recruiting
      Tokyo, Japan, 113
      Contact: GSK Clinical Trials Call Center     1-877-379-3718        

Sponsors and Collaborators
GlaxoSmithKline

Investigators
Study Director:     GSK Clinical Trials, MD     GlaxoSmithKline    
  More Information


Study ID Numbers:   PIR109164
First Received:   November 12, 2007
Last Updated:   September 5, 2008
ClinicalTrials.gov Identifier:   NCT00557622
Health Authority:   Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:
Paroxetine  
PTSD (Posttraumatic Stress Disorder)  
CAPS  
fMRI  

Study placed in the following topic categories:
Anxiety Disorders
Mental Disorders
Stress Disorders, Post-Traumatic
Stress
Paroxetine
Serotonin
Stress Disorders, Traumatic

Additional relevant MeSH terms:
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Pharmacologic Actions
Pathologic Processes
Serotonin Agents
Therapeutic Uses
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on October 07, 2008




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