BRL29060A (Paroxetine Hydrochloride Hydrate) in Posttraumatic Stress Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00839397
First received: January 29, 2009
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Post-Traumatic Stress Disorder
Drug: Paroxetine
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: BRL29060A in Posttraumatic Stress Disorder

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change from baseline in the Clinician-Administered Posttraumatic Stress Disorder Scale One Week Symptom Status Version (CAPS-SX) total score [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of responders based on the CGI Global Improvement [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in the CAPS-SX re-experiencing cluster score [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in the CAPS-SX avoidance/numbing cluster score [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in the CAPS-SX hyperarousal cluster score [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in the CGI Severity of Illness score [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 52
Study Start Date: May 2002
Study Completion Date: June 2005
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Paroxetine
A 52-week, non-comparative, uncontrolled study (However, the baseline phase is single blind)
Drug: Paroxetine

Subjects will take the treatment phase medication once daily after an evening meal. All subjects will be maintained at Dose Level II (20 mg/day) for the first 2 weeks. If a sufficient clinical response ("1. Very much improved" or "2. Much improved" based on the CGI Global Improvement) is achieved, the subject will continue on the same dose level. When the clinical response is not sufficient but the investigational product is well tolerated, the dose will be increased to Dose Level III (30 mg/day) and then to Dose Level IV (40 mg/day) at intervals of at least 2 weeks until a sufficient response is reached. Once a sufficient response is obtained, the treatment will be continued at that dose. The treatment phase will last for a total of 52 weeks. In those patients receiving Dose Level III or IV, dosage reductions to the next lowest level (Dose Level II or III) consequent to an adverse event are permitted.

Dosage adjustment will be made at the discretion of the PI or Sub-PI


  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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%.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00839397

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Yoshiharu Kim, MD, PhD; Nozomu Asukai, MD, PhD; Takako Konishi, MD, PhD; Hiroshi Kato, MD, PhD; Hideto Hirotsune, MD; Masaharu Maeda, MD, PhD; Hirotaka Inoue, PhD; Hiroyasu Narita, PhD; and Masaru Iwasaki, MD, PhD. Clinical evaluation of paroxetine in post-traumatic stress disorder (PTSD): 52-week, non-comparative open- label study for clinical use experience. Psychiatry and Clinical Neurosciences 2008; 62: 646-652.

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00839397     History of Changes
Other Study ID Numbers: 29060/799
Study First Received: January 29, 2009
Last Updated: March 6, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on October 01, 2014